ABSTRACT
PURPOSE: Levonorgestrel-only emergency contraception (EC) inhibits ovulation to prevent fertilization. Misconceptions regarding its mechanism of action contribute to low use in some settings. We aimed to review the mechanism of action of Levonorgestrel EC and assess the evidence for a postovulatory effect on viable pregnancy development in the exposed and subsequent cycles. BASIC PROCEDURES: We searched Pubmed, Embase, Web of Science, clinicaltrials.gov, the Cochrane database, and the US FDA Adverse Event Reporting System. We included studies reporting on the effect of Levonorgestrel EC exposure on (1) ovulation, (2) conception, (3) implantation, (4) ectopic pregnancy, (5) pregnancy viability, and (6) fertility in subsequent cycles. Data were extracted and tabulated from included studies by two researchers. The results were analyzed and summarized in narrative form. MAIN FINDINGS: We included 33 studies. Women exposed to Levonorgestrel EC at or after the LH (luteinizing hormone) surge had similar rates of inhibited ovulation (3 studies) and conception rates (2 studies) as controls. Nine out of ten studies found no difference in endometrial receptivity to implantation after exposure to Levonorgestrel EC compared to controls. The evidence for an association between Levonorgestrel EC and reduced fallopian tube motility or ectopic pregnancy was conflicting. We found no evidence of increased miscarriage or teratogenicity (3 studies) or disrupted menstrual cycle (3 studies) after Levonorgestrel EC exposure compared to controls. PRINCIPAL CONCLUSIONS: This review supports that Levonorgestrel EC taken after ovulation does not affect implantation and results in similar conception rates compared to placebo. There is no evidence that exposure to Levonorgestrel EC affects fetal development, miscarriage, stillbirth, or subsequent menstruations.
Subject(s)
Abortion, Spontaneous , Contraception, Postcoital , Pregnancy, Ectopic , Abortion, Spontaneous/etiology , Contraception, Postcoital/adverse effects , Contraception, Postcoital/methods , Female , Fertility , Humans , Levonorgestrel , Pregnancy , Pregnancy, Ectopic/etiologyABSTRACT
Emergency contraception (EC) has been prescribed for decades, in order to lessen the risk of unplanned and unwanted pregnancy following unprotected intercourse, ordinary contraceptive failure, or rape. EC and the linked aspect of unintended pregnancy undoubtedly constitute highly relevant public health issues, in that they involve women's self-determination, reproductive freedom and family planning. Most European countries regulate EC access quite effectively, with solid information campaigns and supply mechanisms, based on various recommendations from international institutions herein examined. However, there is still disagreement on whether EC drugs should be available without a physician's prescription and on the reimbursement policies that should be implemented. In addition, the rights of health care professionals who object to EC on conscience grounds have been subject to considerable legal and ethical scrutiny, in light of their potential to damage patients who need EC drugs in a timely fashion. Ultimately, reproductive health, freedom and conscience-based refusal on the part of operators are elements that have proven extremely hard to reconcile; hence, it is essential to strike a reasonable balance for the sake of everyone's rights and well-being.
Subject(s)
Contraception, Postcoital/ethics , Health Policy , Pregnancy, Unplanned/ethics , Pregnancy, Unwanted/ethics , Reproductive Health Services/ethics , Reproductive Health Services/legislation & jurisprudence , Women's Health Services/ethics , Women's Health Services/legislation & jurisprudence , Conscientious Refusal to Treat/ethics , Conscientious Refusal to Treat/legislation & jurisprudence , Contraception, Postcoital/adverse effects , Female , Government Regulation , Humans , Patient Rights/ethics , Patient Rights/legislation & jurisprudence , Policy Making , Practice Guidelines as Topic , Practice Patterns, Physicians'/ethics , Practice Patterns, Physicians'/legislation & jurisprudence , Pregnancy , Women's Rights/ethics , Women's Rights/legislation & jurisprudenceABSTRACT
Background: The copper-intrauterine device (Cu-IUD) is the most effective emergency contraception (EC), and the only method providing ongoing contraception; however, it is underutilised in Australia.Methods: An online cross-sectional survey of clients and clinicians at a family planning service was undertaken. Clients aged 16-55 and identifying as female or transgender male were eligible. The survey explored previous experience with and knowledge of the Cu-IUD as EC among clients, current EC practices among clinicians, and barriers and enablers among clients and clinicians.Results: Of 470 clients, 64.5% had previously used EC. Only 12.7% knew the Cu-IUD was a form of EC and 2% had used it. When given information on effectiveness, side-effects and costs, 46.8% reported they would consider the Cu-IUD for EC. However, 40% viewed cost and possible side-effects as barriers. Of the 58 clinicians surveyed, 55% reported discussing Cu-IUD as EC with clients versus 94% discussing oral EC, with time pressures reported as the main barrier.Conclusion: Low awareness among clients, and limited discussion by clinicians, highlights a need for increased education and promotion strategies for the Cu-IUD as EC. With greater knowledge, demand for this option may increase. This will require processes to ensure timely access to insertions.
Subject(s)
Contraception, Postcoital/methods , Intrauterine Devices, Copper , Patient Satisfaction , Adolescent , Adult , Contraception, Postcoital/adverse effects , Cross-Sectional Studies , Female , Health Knowledge, Attitudes, Practice , Humans , Middle Aged , New South Wales , Socioeconomic Factors , Young AdultABSTRACT
Contraception counseling and provision are vital components of comprehensive health care. Unplanned pregnancy can be devastating to any woman but is particularly dangerous for those with chronic illness. Internal medicine providers are in a unique position to provide contraception, as they often intersect with women at the moment of a new medical diagnosis or throughout care for a chronic problem. A shared decision-making approach can engage patients and ensure that they choose a contraceptive method that aligns with their reproductive plans and medical needs.
Subject(s)
Contraception , Coitus Interruptus , Contraception/adverse effects , Contraception/economics , Contraception, Postcoital/adverse effects , Contraceptive Devices, Female/adverse effects , Contraceptives, Oral, Hormonal/adverse effects , Cost-Benefit Analysis , Counseling , Decision Making , Female , Humans , Insurance Coverage , Insurance, Health , Patient Education as Topic , Pregnancy , Pregnancy, Unplanned , Risk Factors , Sterilization, Reproductive/adverse effectsABSTRACT
BACKGROUND: Emergency contraception (EC) is using a drug or copper intrauterine device (Cu-IUD) to prevent pregnancy shortly after unprotected intercourse. Several interventions are available for EC. Information on the comparative effectiveness, safety and convenience of these methods is crucial for reproductive healthcare providers and the women they serve. This is an update of a review previously published in 2009 and 2012. OBJECTIVES: To determine which EC method following unprotected intercourse is the most effective, safe and convenient to prevent pregnancy. SEARCH METHODS: In February 2017 we searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, Popline and PubMed, The Chinese biomedical databases and UNDP/UNFPA/WHO/World Bank Special Programme on Human Reproduction (HRP) emergency contraception database. We also searched ICTRP and ClinicalTrials.gov as well as contacting content experts and pharmaceutical companies, and searching reference lists of appropriate papers. SELECTION CRITERIA: Randomised controlled trials including women attending services for EC following a single act of unprotected intercourse were eligible. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. The primary review outcome was observed number of pregnancies. Side effects and changes of menses were secondary outcomes. MAIN RESULTS: We included 115 trials with 60,479 women in this review. The quality of the evidence for the primary outcome ranged from moderate to high, and for other outcomes ranged from very low to high. The main limitations were risk of bias (associated with poor reporting of methods), imprecision and inconsistency.Comparative effectiveness of different emergency contraceptive pills (ECP)Levonorgestrel was associated with fewer pregnancies than Yuzpe (estradiol-levonorgestrel combination) (RR 0.57, 95% CI 0.39 to 0.84, 6 RCTs, n = 4750, I2 = 23%, high-quality evidence). This suggests that if the chance of pregnancy using Yuzpe is assumed to be 29 women per 1000, the chance of pregnancy using levonorgestrel would be between 11 and 24 women per 1000.Mifepristone (all doses) was associated with fewer pregnancies than Yuzpe (RR 0.14, 95% CI 0.05 to 0.41, 3 RCTs, n = 2144, I2 = 0%, high-quality evidence). This suggests that if the chance of pregnancy following Yuzpe is assumed to be 25 women per 1000 women, the chance following mifepristone would be between 1 and 10 women per 1000.Both low-dose mifepristone (less than 25 mg) and mid-dose mifepristone (25 mg to 50 mg) were probably associated with fewer pregnancies than levonorgestrel (RR 0.72, 95% CI 0.52 to 0.99, 14 RCTs, n = 8752, I2 = 0%, high-quality evidence; RR 0.61, 95% CI 0.45 to 0.83, 27 RCTs, n = 6052, I2 = 0%, moderate-quality evidence; respectively). This suggests that if the chance of pregnancy following levonorgestrel is assumed to be 20 women per 1000, the chance of pregnancy following low-dose mifepristone would be between 10 and 20 women per 1000; and that if the chance of pregnancy following levonorgestrel is assumed to be 35 women per 1000, the chance of pregnancy following mid-dose mifepristone would be between 16 and 29 women per 1000.Ulipristal acetate (UPA) was associated with fewer pregnancies than levonorgestrel (RR 0.59; 95% CI 0.35 to 0.99, 2 RCTs, n = 3448, I2 = 0%, high-quality evidence).Comparative effectiveness of different ECP dosesIt was unclear whether there was any difference in pregnancy rate between single-dose levonorgestrel (1.5 mg) and the standard two-dose regimen (0.75 mg 12 hours apart) (RR 0.84, 95% CI 0.53 to 1.33, 3 RCTs, n = 6653, I2 = 0%, moderate-quality evidence).Mid-dose mifepristone was associated with fewer pregnancies than low-dose mifepristone (RR 0.73; 95% CI 0.55 to 0.97, 25 RCTs, n = 11,914, I2 = 0%, high-quality evidence).Comparative effectiveness of Cu-IUD versus mifepristoneThere was no conclusive evidence of a difference in the risk of pregnancy between the Cu-IUD and mifepristone (RR 0.33, 95% CI 0.04 to 2.74, 2 RCTs, n = 395, low-quality evidence).Adverse effectsNausea and vomiting were the main adverse effects associated with emergency contraception. There is probably a lower risk of nausea (RR 0.63, 95% CI 0.53 to 0.76, 3 RCTs, n = 2186 , I2 = 59%, moderate-quality evidence) or vomiting (RR 0.12, 95% CI 0.07 to 0.20, 3 RCTs, n = 2186, I2 = 0%, high-quality evidence) associated with mifepristone than with Yuzpe. levonorgestrel is probably associated with a lower risk of nausea (RR 0.40, 95% CI 0.36 to 0.44, 6 RCTs, n = 4750, I2 = 82%, moderate-quality evidence), or vomiting (RR 0.29, 95% CI 0.24 to 0.35, 5 RCTs, n = 3640, I2 = 78%, moderate-quality evidence) than Yuzpe. Levonorgestrel users were less likely to have any side effects than Yuzpe users (RR 0.80, 95% CI 0.75 to 0.86; 1 RCT, n = 1955, high-quality evidence). UPA users were more likely than levonorgestrel users to have resumption of menstruation after the expected date (RR 1.65, 95% CI 1.42 to 1.92, 2 RCTs, n = 3593, I2 = 0%, high-quality evidence). Menstrual delay was more common with mifepristone than with any other intervention and appeared to be dose-related. Cu-IUD may be associated with higher risks of abdominal pain than mifepristone (18 events in 95 women using Cu-IUD versus no events in 190 women using mifepristone, low-quality evidence). AUTHORS' CONCLUSIONS: Levonorgestrel and mid-dose mifepristone (25 mg to 50 mg) were more effective than Yuzpe regimen. Both mid-dose (25 mg to 50 mg) and low-dose mifepristone(less than 25 mg) were probably more effective than levonorgestrel (1.5 mg). Mifepristone low dose (less than 25 mg) was less effective than mid-dose mifepristone. UPA may be more effective than levonorgestrel.Levonorgestrel users had fewer side effects than Yuzpe users, and appeared to be more likely to have a menstrual return before the expected date. UPA users were probably more likely to have a menstrual return after the expected date. Menstrual delay was probably the main adverse effect of mifepristone and seemed to be dose-related. Cu-IUD may be associated with higher risks of abdominal pain than ECPs.
Subject(s)
Contraception, Postcoital/methods , Contraceptives, Postcoital/administration & dosage , Contraception, Postcoital/adverse effects , Contraceptives, Postcoital/adverse effects , Drug Administration Schedule , Estradiol/administration & dosage , Estradiol/adverse effects , Female , Humans , Intrauterine Devices, Copper/adverse effects , Intrauterine Devices, Medicated/adverse effects , Levonorgestrel/administration & dosage , Levonorgestrel/adverse effects , Mifepristone/administration & dosage , Mifepristone/adverse effects , Norpregnadienes/administration & dosage , Norpregnadienes/adverse effects , Pregnancy , Pregnancy Rate , Randomized Controlled Trials as Topic , Unsafe SexABSTRACT
Previous studies revealed the increasing risk of tubal pregnancy following failure of levonorgestrel (LNG)-induced emergency contraception, which was attributed to the reduced ciliary motility in response to LNG. However, understanding of the mechanism of LNG-induced reduction in the ciliary beat frequency (CBF) is limited. The transient receptor potential vanilloid (TRPV) 4 channel is located widely in the female reproductive tract and generates an influx of Ca2+ following its activation under normal physiological conditions, which regulates the CBF. The present study aimed to explore whether LNG reduced the CBF in the Fallopian tubes by modulating TRPV4 channels, leading to embryo retention in the Fallopian tubes and subsequent tubal pregnancy. The study provided evidence that the expression of TRPV4 was downregulated in the Fallopian tubes among patients with tubal pregnancy and negatively correlated with the serum level of progesterone. LNG downregulated the expression of TRPV4, limiting the calcium influx to reduce the CBF in mouse oviducts. Furthermore, the distribution of ciliated cells and the morphology of cilia did not change following the administration of LNG. LNG-induced reduction in the CBF and embryo retention in the Fallopian tubes and in mouse oviducts were partially reversed by the progesterone receptor antagonist RU486 or the TRPV4 agonist 4α-phorbol 12,13-didecanoate (4α-PDD). The results indicated that LNG could downregulate the expression of TRPV4 to reduce the CBF in both humans and mice, suggesting the possible mechanism of tubal pregnancy. © 2019 The Authors. The Journal of Pathology published by John Wiley & Sons Ltd on behalf of Pathological Society of Great Britain and Ireland.
Subject(s)
Contraceptives, Postcoital/adverse effects , Levonorgestrel/adverse effects , Oviducts/drug effects , Pregnancy, Tubal/chemically induced , TRPV Cation Channels/physiology , Animals , Calcium/metabolism , Cell Line , Cilia/drug effects , Cilia/physiology , Cilia/ultrastructure , Contraception, Postcoital/adverse effects , Contraceptive Agents, Hormonal/adverse effects , Contraceptive Agents, Hormonal/pharmacology , Contraceptive Effectiveness , Contraceptives, Postcoital/pharmacology , Down-Regulation/drug effects , Epithelial Cells/drug effects , Epithelial Cells/metabolism , Fallopian Tubes/drug effects , Fallopian Tubes/metabolism , Female , Humans , Levonorgestrel/pharmacology , Mice, Inbred C57BL , Microscopy, Electron, Scanning , Oviducts/physiopathology , Oviducts/ultrastructure , Pregnancy , Pregnancy, Tubal/metabolism , Pregnancy, Tubal/physiopathology , Progesterone/blood , Receptors, Progesterone/physiology , TRPV Cation Channels/biosynthesisABSTRACT
OBJECTIVE: The current study aims to evaluate the effect of the use of single packet of levonorgestrel emergency contraceptive pills (LNG-ECPs) during breastfeeding on the health and development of the nursing infant. MATERIALS AND METHODS: The current study was an ancillary observational cohort study carried out in a university hospital. We counseled all women delivered and planning birth-space and breastfeed for at least 1 year for participation during postpartum hospital stay. Eligible participants for inclusion in the randomized controlled trial (NCT01111929) were allocated to receive adequate Lactational Amenorrhea Method (LAM) counseling (LAM-only group) or the LAM counseling in addition to counseling about LNG-ECPs use (LAM + emergency contraception (EC) group). These pills were to be used once if unprotected intercourse did occur after expiry of any of the LAM prerequisites and before the couples started to use a reliable method of contraception. We included the first 100 women in the LAM + EC who did use the pills and the first 100 women in the control group who completed the follow-up visits for 6 months to draw the infants' outcome. The primary outcome was the difference of anthropometric measurements of the infants at 3 and 6 months postpartum. Secondary outcome was the difference in the Psycho-social, fine and gross motor, and language development using Denver development screening test. RESULTS: There were no statistical significant differences between both the groups regarding the infants' weight, length, head circumference, chest circumference, and mid-arm circumference at each visit (p > .05). Additionally, there were no statistically significant differences regarding all items (psycho-social, fine and gross motor, and language) of Denver development screening test between the infants in LAM-only and LAM + EC groups (p = .081). CONCLUSIONS: The use of single packet of LNG-ECPs during breastfeeding not objectively affects health and development of nursing infants or subjectively affects the quantity of breast milk.
Subject(s)
Breast Feeding , Child Development/drug effects , Contraception, Postcoital/adverse effects , Contraceptive Agents, Female/adverse effects , Levonorgestrel/adverse effects , Adult , Cohort Studies , Female , Humans , InfantABSTRACT
Federal regulations governing access to levonorgestrel (LNG) emergency contraception (EC) have evolved since its introduction in the 1990s. LNG EC was initially available by prescription only, but is now available over-the-counter to consumers of all ages. Nonetheless, consumers seeking EC in their communities may face ongoing barriers to access, including low stock and inaccurate information provided by pharmacy staff. We conducted a review of LNG EC secret shopper studies to describe changes in EC access and barriers over time. EC access was compared across all applicable studies, which were published during 2003-2016. When possible, reasons for EC unavailability, helpfulness of pharmacy staff when EC was not in stock, and accuracy of EC information provided by pharmacy staff were described. Overall, access to EC appeared to be improving. However, EC was unavailable during 31 percent of encounters. Pharmacy staff attributed this to "low demand" (30 percent) or EC being "out of stock" (21 percent). Personal objections (9 percent) and store policy (10 percent) were also cited in studies from earlier years. Inaccurate information provided by pharmacy staff persists regarding federal EC regulations, mechanism of action, and drug administration. Pharmacy staff should remain informed about EC and its regulations in order to reduce remaining access barriers.
Subject(s)
Contraception, Postcoital/methods , Contraceptives, Postcoital/supply & distribution , Health Services Accessibility , Levonorgestrel/therapeutic use , Nonprescription Drugs/supply & distribution , Pharmacists/psychology , Adult , Contraception, Postcoital/adverse effects , Female , Humans , Levonorgestrel/administration & dosage , Pharmacies , United StatesABSTRACT
OBJECTIVES: Edit, by the French National College of Gynecologists and Obstetricians (CNGOF), recommendations based on the evidence available in the literature for the use in terms of effectiveness, safety and side effects of emergency contraception (EC). METHODS: A review of the literature was conducted by consulting Medline, Cochrane Library and international recommendations in French and English from January 1, 1979 to May 1, 2018. RESULTS: It is recommended to inform patients that EC is not 100% effective. A pregnancy test is recommended if there is a delay after taking an EC. It is recommended to use EC as soon as possible after the unprotected intercourse. In the absence of long-term contraception, in the first 72hours after unprotected intercourse, ulipristal acetate (UPA) and levonorgestrel (LNG) may be offered with a superiority of UPA from 0 to 72h. Beyond 72hours, the data suggest a better efficiency of the UPA. However, taking into account practical elements (access to EC, cost, impact on the taking of hormonal contraception after UPA), it is difficult to recommend the UPA as a priority between 0 and 72h. Menstruation is more likely to happen early with LNG. The copper IUD is an effective method that can be used in EC until 120hours after unprotected intercourse or when there is a risk of contraceptive failure. CONCLUSIONS: EC is not 100% effective. The closer the intake of EC with the unprotected intercourse, the more effective is the EC in terms of pregnancy rate.
Subject(s)
Contraception, Postcoital , Contraception, Postcoital/adverse effects , Contraception, Postcoital/methods , Female , France , Humans , Intrauterine Devices, Copper , Levonorgestrel/administration & dosage , MEDLINE , Norpregnadienes/administration & dosage , Pregnancy , Pregnancy Tests , Unsafe SexABSTRACT
BACKGROUND: Emergency contraception (EC) is using a drug or copper intrauterine device (Cu-IUD) to prevent pregnancy shortly after unprotected intercourse. Several interventions are available for EC. Information on the comparative effectiveness, safety and convenience of these methods is crucial for reproductive healthcare providers and the women they serve. This is an update of a review previously published in 2009 and 2012. OBJECTIVES: To determine which EC method following unprotected intercourse is the most effective, safe and convenient to prevent pregnancy. SEARCH METHODS: In February 2017 we searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, Popline and PubMed, The Chinese biomedical databases and UNDP/UNFPA/WHO/World Bank Special Programme on Human Reproduction (HRP) emergency contraception database. We also searched ICTRP and ClinicalTrials.gov as well as contacting content experts and pharmaceutical companies, and searching reference lists of appropriate papers. SELECTION CRITERIA: Randomised controlled trials including women attending services for EC following a single act of unprotected intercourse were eligible. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. The primary review outcome was observed number of pregnancies. Side effects and changes of menses were secondary outcomes. MAIN RESULTS: We included 115 trials with 60,479 women in this review. The quality of the evidence for the primary outcome ranged from moderate to high, and for other outcomes ranged from very low to high. The main limitations were risk of bias (associated with poor reporting of methods), imprecision and inconsistency. Comparative effectiveness of different emergency contraceptive pills (ECP)Levonorgestrel was associated with fewer pregnancies than Yuzpe (estradiol-levonorgestrel combination) (RR 0.57, 95% CI 0.39 to 0.84, 6 RCTs, n = 4750, I2 = 23%, high-quality evidence). This suggests that if the chance of pregnancy using Yuzpe is assumed to be 29 women per 1000, the chance of pregnancy using levonorgestrel would be between 11 and 24 women per 1000.Mifepristone (all doses) was associated with fewer pregnancies than Yuzpe (RR 0.14, 95% CI 0.05 to 0.41, 3 RCTs, n = 2144, I2 = 0%, high-quality evidence). This suggests that if the chance of pregnancy following Yuzpe is assumed to be 25 women per 1000 women, the chance following mifepristone would be between 1 and 10 women per 1000.Both low-dose mifepristone (less than 25 mg) and mid-dose mifepristone (25 mg to 50 mg) were probably associated with fewer pregnancies than levonorgestrel (RR 0.72, 95% CI 0.52 to 0.99, 14 RCTs, n = 8752, I2 = 0%, high-quality evidence; RR 0.61, 95% CI 0.45 to 0.83, 27 RCTs, n = 6052, I2 = 0%, moderate-quality evidence; respectively). This suggests that if the chance of pregnancy following levonorgestrel is assumed to be 20 women per 1000, the chance of pregnancy following low-dose mifepristone would be between 10 and 20 women per 1000; and that if the chance of pregnancy following levonorgestrel is assumed to be 35 women per 1000, the chance of pregnancy following mid-dose mifepristone would be between 16 and 29 women per 1000.Ulipristal acetate (UPA) was associated with fewer pregnancies than levonorgestrel (RR 0.59; 95% CI 0.35 to 0.99, 2 RCTs, n = 3448, I2 = 0%, high-quality evidence). Comparative effectiveness of different ECP dosesIt was unclear whether there was any difference in pregnancy rate between single-dose levonorgestrel (1.5 mg) and the standard two-dose regimen (0.75 mg 12 hours apart) (RR 0.84, 95% CI 0.53 to 1.33, 3 RCTs, n = 6653, I2 = 0%, moderate-quality evidence).Mid-dose mifepristone was associated with fewer pregnancies than low-dose mifepristone (RR 0.73; 95% CI 0.55 to 0.97, 25 RCTs, n = 11,914, I2 = 0%, high-quality evidence). Comparative effectiveness of Cu-IUD versus mifepristoneThere was no conclusive evidence of a difference in the risk of pregnancy between the Cu-IUD and mifepristone (RR 0.33, 95% CI 0.04 to 2.74, 2 RCTs, n = 395, low-quality evidence). Adverse effectsNausea and vomiting were the main adverse effects associated with emergency contraception. There is probably a lower risk of nausea (RR 0.63, 95% CI 0.53 to 0.76, 3 RCTs, n = 2186 , I2 = 59%, moderate-quality evidence) or vomiting (RR 0.12, 95% CI 0.07 to 0.20, 3 RCTs, n = 2186, I2 = 0%, high-quality evidence) associated with mifepristone than with Yuzpe. levonorgestrel is probably associated with a lower risk of nausea (RR 0.40, 95% CI 0.36 to 0.44, 6 RCTs, n = 4750, I2 = 82%, moderate-quality evidence), or vomiting (RR 0.29, 95% CI 0.24 to 0.35, 5 RCTs, n = 3640, I2 = 78%, moderate-quality evidence) than Yuzpe. Levonorgestrel users were less likely to have any side effects than Yuzpe users (RR 0.80, 95% CI 0.75 to 0.86; 1 RCT, n = 1955, high-quality evidence). UPA users were more likely than levonorgestrel users to have resumption of menstruation after the expected date (RR 1.65, 95% CI 1.42 to 1.92, 2 RCTs, n = 3593, I2 = 0%, high-quality evidence). Menstrual delay was more common with mifepristone than with any other intervention and appeared to be dose-related. Cu-IUD may be associated with higher risks of abdominal pain than mifepristone (18 events in 95 women using Cu-IUD versus no events in 190 women using mifepristone, low-quality evidence). AUTHORS' CONCLUSIONS: Levonorgestrel and mid-dose mifepristone (25 mg to 50 mg) were more effective than Yuzpe regimen. Both mid-dose (25 mg to 50 mg) and low-dose mifepristone(less than 25 mg) were probably more effective than levonorgestrel (1.5 mg). Mifepristone low dose (less than 25 mg) was less effective than mid-dose mifepristone. UPA was more effective than levonorgestrel.Levonorgestrel users had fewer side effects than Yuzpe users, and appeared to be more likely to have a menstrual return before the expected date. UPA users were probably more likely to have a menstrual return after the expected date. Menstrual delay was probably the main adverse effect of mifepristone and seemed to be dose-related. Cu-IUD may be associated with higher risks of abdominal pain than ECPs.
Subject(s)
Contraception, Postcoital/methods , Contraceptives, Postcoital/administration & dosage , Contraception, Postcoital/adverse effects , Contraceptives, Postcoital/adverse effects , Drug Administration Schedule , Estradiol/administration & dosage , Estradiol/adverse effects , Female , Humans , Intrauterine Devices, Copper/adverse effects , Intrauterine Devices, Medicated/adverse effects , Levonorgestrel/administration & dosage , Levonorgestrel/adverse effects , Mifepristone/administration & dosage , Mifepristone/adverse effects , Norpregnadienes/administration & dosage , Norpregnadienes/adverse effects , Pregnancy , Pregnancy Rate , Randomized Controlled Trials as Topic , Unsafe SexABSTRACT
INTRODUCTION: Emergency contraception (EC) is a way to significantly reduce the chance of becoming pregnant after an episode of unprotected intercourse. Considerable data support the safety of all available and emerging options for EC. Areas covered: This review presents a comprehensive summary of the literature regarding the safety of EC as well as directions for further study. PubMed was searched for all relevant studies published prior to June 2017. Expertopinion: All available methods of EC (i.e., ulipristal acetate pills, levonorgestrel pills, and the copper-IUD), carry only mild side effects and serious adverse events are essentially unknown. The copper IUD has the highest efficacy of EC methods. Given the excellent safety profiles of mifepristone and the levonorgestrel IUD, research is ongoing related to use of these products for EC.
Subject(s)
Contraception, Postcoital/methods , Contraceptives, Postcoital/administration & dosage , Animals , Contraception, Postcoital/adverse effects , Contraceptives, Postcoital/adverse effects , Female , Humans , Intrauterine Devices, Copper/adverse effects , Levonorgestrel/administration & dosage , Levonorgestrel/adverse effects , Norpregnadienes/administration & dosage , Norpregnadienes/adverse effects , PregnancyABSTRACT
INTRODUCTION: The emergency contraceptive ulipristal acetate (UPA) 30 mg is increasingly used by women, but there is no published data on UPA exposure in pregnancy. CASE REPORT: Here we describe five cases of unintended pregnancies following the use of UPA for emergency contraception. Of five pregnant women exposed to UPA, one decided to terminate the pregnancy for personal reasons. Two of them experienced premature rupture of membranes and the babies were born large for gestational age (LGA). The other two women experienced gestational diabetes, and one of them also delivered a LGA baby. The blood glucose levels of the mothers were normal after delivery and at six weeks postpartum. No birth defects and no growth or developmental abnormalities for the infants were reported during 6 months follow-up. CONCLUSION: Pregnant women inadvertently exposed to UPA should be monitored carefully, unless further data are available.
Subject(s)
Contraception, Postcoital/adverse effects , Contraceptive Agents, Female/adverse effects , Contraceptive Effectiveness , Norpregnadienes/adverse effects , Adult , Diabetes, Gestational/etiology , Female , Fetal Macrosomia/etiology , Fetal Membranes, Premature Rupture/etiology , Humans , Infant, Newborn , Male , Pregnancy , Pregnancy Outcome , Pregnancy, Unplanned , Retrospective StudiesABSTRACT
INTRODUCTION: After years of complex regulatory changes, levonorgestrel (LNG) emergency contraception (EC) is now approved for unrestricted sale in the United States. Timely access to EC pills is critical because they are more likely to work the sooner they are taken. This study assesses whether LNG EC is sold in accordance with current Food and Drug Administration regulations. METHODS: We distributed an online questionnaire through an EC-focused listserv for reproductive health professionals, asking data collectors to visit local stores and document product names, price, over-the-counter shelf availability, and misinformation about age restrictions. We used χ2 analysis to assess bivariate associations and t tests and Wilcoxon rank-sum tests to determine differences in means. RESULTS: We collected information about 220 stores. The majority (65%) stocked EC on over-the-counter shelves, although only 22% of these displayed it without a locked security enclosure. Chain pharmacies were more likely to shelf-stock EC than independent pharmacies (77% vs. 5%; p = .000), but variation existed among stores within the same chain. Among stores that were asked, 40% incorrectly reported an age restriction for non-prescription purchase of LNG EC, whereas 95% correctly reported that men can buy LNG EC. The average price of branded and generic LNG EC was $49.64 and $40.05, respectively. CONCLUSIONS: Changes in the regulatory status of LNG EC have resulted in widespread confusion about how EC can be sold, and its high price contributes to access barriers. Retailers should ensure that consumers can access LNG EC quickly and easily by stocking the product on over-the-counter shelves and educating staff about current regulations.
Subject(s)
Contraception, Postcoital/methods , Health Services Accessibility/legislation & jurisprudence , Levonorgestrel/therapeutic use , Nonprescription Drugs , Social Control, Formal , Adolescent , Adult , Age Factors , Contraception, Postcoital/adverse effects , Female , Humans , Levonorgestrel/administration & dosage , Male , United StatesABSTRACT
Emergency contraception (EC) may help prevent pregnancy in various circumstances, such as contraceptive method failure, unprotected sexual intercourse, or sexual assault, yet it remains underused. There are 4 approved EC options in the United States. Although ulipristal acetate requires a provider's prescription, oral levonorgestrel (LNG) is available over the counter for women of all ages. The most effective method of EC is the copper intrauterine device, which can be left in place for up to 10 years for efficacious, cost-effective, hormone-free, and convenient long-term primary contraception. Ulipristal acetate tends to be more efficacious in pregnancy prevention than is LNG, especially when taken later than 72 hours postcoitus. The mechanism of action of oral EC is delay of ovulation, and current evidence reveals that it is ineffective postovulation. Women who weigh more than 75 kg or have a body mass index greater than 25 kg/m(2) may have a higher risk of unintended pregnancy when using oral LNG EC; therefore, ulipristal acetate or copper intrauterine devices are preferable in this setting. Providers are often unaware of the range of EC options or are unsure of how to counsel patients regarding the access and use of EC. This article critically reviews current EC literature, summarizes recommendations, and provides guidance for counseling women about EC. Useful tips for health care providers are provided, with a focus on special populations, including breast-feeding women and those transitioning to long-term contraception after EC use. When treating women of reproductive age, clinicians should be prepared to counsel them about EC options, provide EC appropriately, and, if needed, refer for EC in a timely manner.
Subject(s)
Contraception, Postcoital/methods , Health Knowledge, Attitudes, Practice , Intrauterine Devices, Copper , Levonorgestrel , Norpregnadienes , Ovulation/drug effects , Administration, Oral , Attitude of Health Personnel , Body Mass Index , Breast Feeding , Contraception, Postcoital/adverse effects , Contraception, Postcoital/economics , Contraceptive Agents, Female/administration & dosage , Contraceptive Agents, Female/adverse effects , Contraceptive Agents, Female/economics , Contraceptive Agents, Female/supply & distribution , Contraceptives, Postcoital/administration & dosage , Contraceptives, Postcoital/adverse effects , Contraceptives, Postcoital/economics , Contraceptives, Postcoital/supply & distribution , Female , Humans , Intrauterine Devices, Copper/adverse effects , Intrauterine Devices, Copper/economics , Intrauterine Devices, Copper/supply & distribution , Levonorgestrel/administration & dosage , Levonorgestrel/adverse effects , Levonorgestrel/economics , Levonorgestrel/supply & distribution , Nonprescription Drugs/economics , Nonprescription Drugs/standards , Nonprescription Drugs/supply & distribution , Norpregnadienes/administration & dosage , Norpregnadienes/adverse effects , Norpregnadienes/economics , Norpregnadienes/supply & distribution , Patient Education as Topic/methods , Pregnancy , Prescription Drugs/economics , Prescription Drugs/standardsABSTRACT
OBJECTIVE: This study aims to determine whether emergency contraceptive pills (ECPs) are less safe and effective for women with obesity compared with those without obesity. STUDY DESIGN: We searched PubMed for articles through November 2015 regarding the safety and effectiveness of ECPs [ulipristal acetate (UPA), levonorgestrel (LNG) and combined estrogen and progestin] among obese users. We assessed study quality using the United States Preventive Services Task Force evidence grading system. RESULTS: We identified four pooled secondary analyses (quality: poor to fair), two of which examined UPA and three examined LNG formulations. Three analyses pooled overlapping data from a total of three primary studies and demonstrated significant associations between obesity and risk of pregnancy after ECP use. One analysis reported a 4-fold increased risk of pregnancy among women with obesity (BMI≥30kg/m2) compared with women within normal/underweight categories (BMI<25kg/m2) after use of LNG ECPs [odds ratio (OR) 4.4; 95% confidence interval (CI) 2.0-9.4]. Further analysis of the same LNG data found that, at an approximate weight of 80 kg, the rate of pregnancy rose above 6%, which is the estimated pregnancy probability without contraception; at weights less than 75 kg, the rate of pregnancy was less than 2%. Two analyses examining UPA suggested an approximate 2-fold increased risk of pregnancy among women with obesity compared with either normal/underweight women or nonobese (BMI<30kg/m2) women (OR 2.6; 95% CI 0.9-7.0 and OR 2.1; 95% CI 1.0-4.3, respectively), but CIs were wide. Finally, the fourth secondary analysis pooled data from three separate randomized controlled trials on LNG ECPs and found no increase in pregnancy risk with increasing weight or BMI and found no consistent association between pregnancy and both factors when adjusted for other covariates. CONCLUSION: While data are limited and poor to fair quality, findings suggest that women with obesity experience an increased risk of pregnancy after use of LNG ECP compared with those normal/underweight. Women with obesity may also experience an increased risk of pregnancy compared with women without obesity after use of UPA ECP, though differences did not reach statistical significance. Providers should counsel all women at risk for unintended pregnancy, including those with obesity, about the effectiveness of the full range of emergency contraception options in order for them to understand their options, to receive advanced supplies of emergency contraception as needed and to understand how to access an emergency copper intrauterine device if desired.
Subject(s)
Contraception, Postcoital/adverse effects , Contraceptive Agents, Female/adverse effects , Obesity/complications , Pregnancy, Unplanned , Body Mass Index , Body Weight , Female , Humans , Levonorgestrel/adverse effects , Norpregnadienes/adverse effects , Pregnancy , Randomized Controlled Trials as Topic , Risk Assessment , Risk FactorsABSTRACT
Female hormones play a significant role in the etiology and treatment of many women's health conditions. This article focuses on the common uses of hormonal therapy. When prescribing estrogen-containing regimens throughout the span of a woman's life, the risks are similar (ie, cardiovascular risk and venous thromboembolism), but the degree of risk varies significantly depending on a woman's particular set of risk factors and the details of the hormone regimen. In addition to estrogens and progestogens, this article also touches on the use of selective steroid receptor modulators in emergency contraception and in treatment of menopause symptoms.
Subject(s)
Contraception/methods , Contraceptive Agents, Female/therapeutic use , Contraceptive Devices, Female , Estrogen Replacement Therapy/methods , Menopause , Women's Health , Contraception/adverse effects , Contraception, Postcoital/adverse effects , Contraception, Postcoital/methods , Contraceptive Agents, Female/administration & dosage , Contraceptive Agents, Female/adverse effects , Delayed-Action Preparations , Drug Administration Routes , Estrogen Replacement Therapy/adverse effects , Estrogens/therapeutic use , Female , Flushing/drug therapy , Humans , Progestins/therapeutic use , Risk Factors , Selective Estrogen Receptor Modulators/therapeutic useABSTRACT
INTRODUCTION: Emergency contraception is a safe and effective method to prevent an unwanted pregnancy after an unprotected or inadequately protected sexual intercourse. Several methods for emergency contraception (EC) are currently registered in many countries for use in an emergency to prevent a pregnancy following an unprotected, possibly fertile intercourse or after a contraceptive accident like condom rupture. Different methods have varying modes of action, time frame of efficacy, dosage schedule and unwanted effects. Since several methods are available it is important to decide the best method. EVIDENCE ACQUISITION: In this article the available literature on emergency contraception has been reviewed and an attempt has been made to discuss the need for emergency contraception and compare different options for emergency contraception in terms of their efficacy in pregnancy prevention, their safety profile and unwanted side effects. EC repeated use and initiating a regular method after EC use are also discussed. EVIDENCE SYNTHESIS: Emergency contraceptive methods include copper Intra-uterine devices (IUD) and different types of pills like estrogen progestin combination pill (Yuzpe Regimen), Progestin only pill (LNG), antiprogestin pill (Mifepristone), and progesterone modulator Uripristal Acetate (UPA). There is a marginal difference in the mechanism of action, efficacy including time frame and ability to protect from pregnancy with regular doses in obese women, drug interactions and side effects. These are discussed in detail. CONCLUSIONS: Copper IUD is the most effective emergency contraceptive with advantage of providing continued contraception. However, it cannot be used universally due to lack of infrastructure and a trained provider as well as not being suitable option for women at risk of sexually transmitted infections. Amongst different pills LNG is more effective with fewer side effects than Yuzpe regimen. LNG and UPA are comparable with similar efficacy and side effect profile. UPA has a wider window of efficacy, in LNG efficacy declines after 72 hours. UPA is more suitable for obese women. Mifepristone is effective but is registered as EC pill only in few countries and use is limited as it is also used as an abortion pill. Yuzpe regimen is the least effective of all contraceptive pills as EC, and works only till 72 hours of unprotected sex, but is useful in places where dedicated methods are not available, as it is easily accessible. Any combined pill can be used in this regimen except triphasic pill.
Subject(s)
Contraception, Postcoital/methods , Contraceptives, Postcoital/administration & dosage , Intrauterine Devices, Copper , Contraception, Postcoital/adverse effects , Contraceptives, Postcoital/adverse effects , Contraceptives, Postcoital/pharmacology , Female , Humans , Pregnancy , Pregnancy, UnwantedABSTRACT
STUDY OBJECTIVE: To determine the awareness of, access to, and knowledge of the proper use of emergency contraception pills (ECPs) among uninsured adolescents. DESIGN: Anonymous surveys were used to assess awareness of, knowledge of, and access to ECPs. SETTING: From 2010 to 2012 at mobile primary care clinic in the San Francisco Bay Area. PARTICIPANTS: Patients were uninsured adolescents aged 13 to 25; 40% of the participants were currently or had been homeless in the past year. Ethnicity was 50% Asian, 22% Hispanic, 17% Pacific Islanders, 5.5% white, and 5.5% other/mixed ethnicity. INTERVENTIONS: Post survey completion, patients received one-on-one 15-minute dedicated ECP education. MAIN OUTCOME MEASURES: Awareness of, knowledge of, and access to ECPs. RESULTS: Of the study population of 439, 30% of the participants were 13-16 years old and 70% were 17-25 years old (mean age 17.8 years); 66% were women. Young women (86%) reported higher rates of "hearing about emergency contraception" than did young men (70%) (P < .0001). Many incorrectly identified or were uncertain if ECPs were an abortion pill (40%) or could be used as regular birth control (40%) or to prevent sexually transmitted infections (19%). Only 40% of women and 43% of men aged 17 and older correctly answered that they could obtain EC over the counter; 72% did not know that males could receive EC for use by their partner; 12% incorrectly selected that infertility was a side effect; 44% were under the false impression that EC had to be taken within 1 day of unprotected sex. CONCLUSIONS: Uninsured adolescents have high rates of ECP awareness but low ECP knowledge. These adolescents need more ECP education to alleviate misconceptions and increase practical knowledge, specifically, education about male access, side effects, over-the-counter availability for young men and women, and the 120-hour window of use.
Subject(s)
Contraception, Postcoital/methods , Contraceptives, Postcoital , Health Knowledge, Attitudes, Practice , Health Services Accessibility/statistics & numerical data , Adolescent , Adult , Aged , Contraception, Postcoital/adverse effects , Ethnicity , Female , Humans , Male , Medically Uninsured , Pregnancy , Retrospective Studies , San Francisco , Surveys and Questionnaires , Young AdultABSTRACT
Cases of ectopic pregnancy (EP) following levonorgestrel emergency contraception (LNG-EC) failure have been reported continuously, but whether there is an association between EP risk and LNG-EC is unclear. We concluded a case-control study to explore this association by recruiting 2,411 EP patients as case group, and 2,416 women with intrauterine pregnancy and 2,419 non-pregnant women as control groups. Odds ratios (ORs) and their 95% confidential intervals (CIs) were calculated and adjusted for potential confounding factors. Previous use of LNG-EC was not correlated with the EP. Compared to women who did not use contraceptives, current use of LNG-EC reduced the risk for intrauterine pregnancy (Adjusted OR [AOR] = 0.20, 95%CI: 0.14-0.27), but did not increase the risk for EP (AOR2 = 1.04, 95%CI: 0.76-1.42). Furthermore, compared to women who did not have further act of intercourse, women with unprotected further act of intercourse were at a higher risk of EP (AOR1 = 2.35, 95%CI: 1.17-4.71), and women with repeated use of LNG-EC for further intercourse during the same cycle was also associated with a higher risk for EP (AOR1 = 3.08, 95%CI: 1.09-8.71; AOR2 = 2.49, 95%CI: 1.00-6.19). A better understanding of the risk of EP following LNG-EC failure can optimize LNG-EC use and thus reduce the risk of EP.