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1.
Eur J Contracept Reprod Health Care ; 28(2): 141-146, 2023 Apr.
Article in English | MEDLINE | ID: covidwho-2311365

ABSTRACT

PURPOSE: To evaluate feasibility and acceptability of a medical abortion service that offers: a telemedicine visit (in place of an in-person visit) during a mandatory waiting period, and at-home follow-up with the use of multi-level pregnancy tests (MLPT). METHODS: Participants were screened for eligibility in clinic, and during the waiting period, received a telephone call to confirm desire to proceed with the service. Participants were mailed a study package containing mifepristone, misoprostol, two multi-level pregnancy tests, and instructions for their use. Follow-up consultation took place by phone to evaluate abortion completeness. The analysis was descriptive. RESULTS: One-hundred twenty-two participants were enrolled in the study, and 120 chose to proceed with the abortion after the waiting period and were sent a study package. One participant was lost to follow up. The majority of participants did not experience problems receiving the study package (94.1%, n = 112), took mifepristone (100%, n = 119), misoprostol (99.2%, n = 118), and MLPTs (99.1%, n = 116) as instructed, and forwent additional clinic visits (91.6%, n = 109). All participants were satisfied with the service. Most participants had a complete abortion without a procedure (95.8%, n = 114). CONCLUSIONS: The adapted telemedicine medical abortion service was feasible and satisfactory to participants and has the potential to make medical abortion more patient-centered where waiting periods are mandated.


Subject(s)
Misoprostol , Telemedicine , Pregnancy , Female , Humans , Mifepristone , Georgia , Prospective Studies , Self Administration , Ambulatory Care
2.
Semin Reprod Med ; 40(5-06): 268-276, 2022 11.
Article in English | MEDLINE | ID: covidwho-2310052

ABSTRACT

Mifepristone medication abortion was first approved in China and France more than 30 years ago and is now used in more than 60 countries worldwide. It is a highly safe and effective method that has the potential to increase population access to abortion in early pregnancy, closer to home. In both Canada and the United States, the initial regulations for distribution, prescribing, and dispensing of mifepristone were highly restricted. However, in Canada, where mifepristone was made available in 2017, most restrictions on the medication were removed in the first year of its availability. The Canadian regulation of mifepristone as a normal prescription makes access possible in community primary care through a physician or nurse practitioner prescription, which any pharmacist can dispense. In this approach, people decide when and where to take their medication. We explore how policy-maker-engaged research advanced reproductive health policy and facilitated this rapid change in Canada. We discuss the implications of these policy advances for self-management of abortion and demonstrate how in Canada patients "self-manage" components of the abortion process within a supportive health care system.


Subject(s)
Abortion, Spontaneous , Misoprostol , Pregnancy , Female , Humans , United States , Mifepristone/therapeutic use , Canada , Reproductive Health , Health Policy
4.
BMJ Sex Reprod Health ; 49(3): 176-182, 2023 07.
Article in English | MEDLINE | ID: covidwho-2257162

ABSTRACT

OBJECTIVE: To examine the numbers and characteristics of women and pregnant people in Malta seeking at-home medical abortion using online telemedicine from 2017 to 2021. DESIGN: Population-based study. SETTING: Republic of Malta PARTICIPANTS: Between 1 January 2017 and 31 December 2021, 1090 women and pregnant people requested at-home medical abortion through one online telemedicine provider (Women on Web). Mifepristone and misoprostol were shipped to 658 women (60.4% of requests). MAIN OUTCOME MEASURES: The numbers and demographics of persons to which abortion pills were shipped, their reasons for accessing abortion, and reasons for requesting medical abortion via telemedicine between January 2017 and December 2021 were analysed. Selected data were compared across different groups. RESULTS: The number of people in Malta to whom medical abortion pills were shipped increased significantly in the 5 years analysed. Women and pregnant people requesting medical abortion were diverse with respect to age, pregnancy circumstances and reasons for seeking an abortion. More than half had existing children and over 90% reached out to Women on Web at <7 weeks. Among those completing a medical abortion, 63% did not use contraception, and in 30% there was contraception failure. The most common reasons for ordering medical abortion pills online were difficulty accessing abortion because of legal restrictions (73%) and abortion pills not being available (45%) in the country. CONCLUSIONS: Despite a complete ban on abortion, the number of women and pregnant people residing in Malta completing at-home medical abortions is considerable and has been steadily increasing.


Subject(s)
Abortion, Induced , Misoprostol , Self-Management , Telemedicine , Pregnancy , Child , Female , Humans , Malta , Abortion, Induced/methods , Misoprostol/therapeutic use
5.
Anaerobe ; 80: 102699, 2023 Apr.
Article in English | MEDLINE | ID: covidwho-2176141

ABSTRACT

We analyzed our challenging experience with a randomized controlled trial of misoprostol for prevention of recurrent C. difficile. Despite careful prescreening and thoughtful protocol modifications to facilitate enrollment, we closed the study early after enrolling just 7 participants over 3 years. We share lessons learned, noting the importance of feasibility studies, inclusion of biomarker outcomes, and dissemination of such findings to inform future research design and implementation successes.


Subject(s)
COVID-19 , Clostridioides difficile , Clostridium Infections , Misoprostol , Humans , COVID-19/prevention & control , Misoprostol/therapeutic use , Clostridioides , Feasibility Studies , Clostridium Infections/prevention & control
6.
BMC Womens Health ; 22(1): 333, 2022 08 05.
Article in English | MEDLINE | ID: covidwho-2196219

ABSTRACT

BACKGROUND: Abortion is highly restricted in Indonesia; self-administered misoprostol can safely induce an abortion. Brick and mortar pharmacies, a common place to purchase misoprostol off-label in other parts of the world, are monitored closely by the government authority in Indonesia which controls drugs so that they cannot function outside the law without risking arrest and prosecution. An online marketplace has sprung up in response that sells misoprostol through in-country distributors. Such procurement offers a level of safety and anonymity to the buyer and seller. So as to understand online access to misoprostol, we created a protocol to identify the most visible universe of sellers. METHODS: We carried out a mystery client methodology to replicate the experiences of women procuring misoprostol online. Our study consisted of five stages: (1) identify the universe of online sellers using the most common search terms, drawn from multiple platforms to capture diversity in interactions as well as products sold (2) remove duplicates across sites as determined by their telephone numbers (3) draw a roughly probability proportional to size sample (4) contact sellers as mystery clients through text/chat, depending on the platform, and engage with them and (5) attempt to purchase drugs offered by the seller. Descriptive statistics are presented. RESULTS: The listing generated 727 sites: 441 websites, 153 marketplace sellers, and 133 Instagram profiles. After removing duplicate listings, we identified 281 unique sellers. We selected all sellers with greater than 12 listings, 60% of sellers with 4-12 listings, 50% of sellers with 2-3 listings, and 40% of sellers with only one listing. Mystery clients were able to send initial messages to 110 sellers, of which 16 never responded. The interaction progressed to purchasing misoprostol with 76 sellers, 64 of whom sent drugs. CONCLUSIONS: As women seek to terminate unwanted pregnancies in legally restrictive settings, online sales of misoprostol must be considered. With the Covid pandemic constraining movement, the importance of this way of procuring misoprostol will likely become more appealing. Understanding this unregulated landscape is important if we are to try to improve women's ability to safely conduct an abortion in highly restrictive settings.


Subject(s)
Abortifacient Agents, Nonsteroidal , Abortion, Induced , COVID-19 , Misoprostol , Abortifacient Agents, Nonsteroidal/therapeutic use , Abortion, Induced/methods , Female , Humans , Indonesia , Pregnancy
7.
Lancet ; 400(10353): 670-679, 2022 08 27.
Article in English | MEDLINE | ID: covidwho-2016259

ABSTRACT

BACKGROUND: Telemedicine for medical abortion increases access to safe abortion but its use has not been described in a controlled trial. We aimed to investigate the effectiveness, adherence, safety, and acceptability of a modified telemedicine protocol for abortion compared with standard care in a low-resource setting. METHODS: In this randomised, controlled, non-inferiority trial we recruited women seeking medical abortion at or before 9 gestational weeks at four public health clinics in South Africa. Participants were randomly allocated (1:1) by computer-generated blocks of varying sizes to telemedicine or standard care. The telemedicine group received asynchronous online abortion consultation and instruction, self-assessed gestational duration, and had a uterine palpation as a safety measure. Participants in this group took 200 mg mifepristone and 800 µg misoprostol at home. The standard care group received in-person consultation and instruction together with an ultrasound, took 200 mg mifepristone in clinic and 800 µg misoprostol at home. Our primary outcome was complete abortion after initial treatment, assessed at a 6-week interview. Our non-inferiority margin was 4%. Group differences were assessed by modified intention-to-treat (mITT) analysis and per protocol. The trial is registered at ClinicalTrials.gov, NCT04336358, and the Pan African Clinical Trials Registry, PACTR202004661941593. FINDINGS: Between Feb 28, 2020, and Oct 5, 2021, we enrolled 900 women, 153 (17·0%) of whom were discontinued before the abortion and were not included in the analysis. By mITT analysis, 355 (95·4%) of 372 women in the telemedicine group had a complete abortion compared with 338 (96·6%) of 350 in the standard care group (odds ratio 0·74 [95% CI 0·35 to 1·57]). The risk difference was -1·1% (-4·0 to 1·7). Among women who completed treatment as allocated (per protocol), 327 (95·6%) of 342 women in telemedicine group had complete abortion, compared with 338 (96·6%) of 350 in the standard care group (0·77 [0·36 to 1·68]), with a risk difference of -1·0% (-3·8 to 1·9). One participant (in the telemedicine group) had a ruptured ectopic pregnancy, and a further four participants were admitted to hospital (two in each group), of whom two had blood transfusions (one in each group). INTERPRETATION: Asynchronous online consultation and instruction for medical abortion and home self-medication, with uterine palpation as the only in-person component, was non-inferior to standard care with respect to rates of complete abortion, and did not affect safety, adherence, or satisfaction. FUNDING: Grand Challenges Canada and the Swedish Research Council.


Subject(s)
Abortion, Induced , Abortion, Spontaneous , Misoprostol , Telemedicine , Female , Humans , Mifepristone , Pregnancy , South Africa
8.
Am J Ther ; 29(5): e534-e543, 2022.
Article in English | MEDLINE | ID: covidwho-2001509

ABSTRACT

BACKGROUND: The U.S. Supreme Court's Dobbs v. Jackson Women's Health Organization decision on June 24, 2022 effectively overturned federal constitutional protections for abortion that have existed since 1973 and returned jurisdiction to the states. Several states implemented abortion bans, some of which banned abortion after 6 weeks and others that permit abortion under limited exceptions, such as if the health or the life of the woman is in danger. Other states introduced bills that define life as beginning at fertilization. As a result of these new and proposed laws, the future availability of mifepristone, one of two drugs used for medical abortion in the United States, has become the topic of intense debate and speculation. AREAS OF UNCERTAINTY: Although its safety and effectiveness has been confirmed by many studies, the use of mifepristone has been politicized regularly since its approval. Areas of future study include mifepristone for induction termination and fetal demise in the third trimester and the management of leiomyoma. DATA SOURCES: PubMed, Society of Family Planning, American College of Obstetricians and Gynecologists, the World Health Organization. THERAPEUTIC ADVANCES: The use of no-touch medical abortion, which entails providing a medical abortion via a telehealth platform without a screening ultrasound or bloodwork, expanded during the COVID-19 pandemic, and studies have confirmed its safety. With the Dobbs decision, legal abortion will be less accessible and, consequently, self-managed abortion with mifepristone and misoprostol will become more prevalent. CONCLUSIONS: Mifepristone and misoprostol are extremely safe medications with many applications. In the current changing political climate, physicians and pregnancy-capable individuals must have access to these medications.


Subject(s)
Abortion, Induced , COVID-19 Drug Treatment , Misoprostol , Self-Management , Abortion, Induced/methods , Female , Humans , Mifepristone/adverse effects , Misoprostol/adverse effects , Pandemics , Pregnancy , United States
9.
J Perinat Med ; 50(9): 1180-1188, 2022 Nov 25.
Article in English | MEDLINE | ID: covidwho-1987191

ABSTRACT

OBJECTIVES: With an increasing incidence of labor induction the socioeconomic costs are increasing and the burden on hospital capacities is rising. In addition, the worldwide SARS-CoV-2 pandemic asks for improvements in patient care during pregnancy and delivery while decreasing the patient-staff contact. Here, we are retrospectively analyzing and comparing a mechanical ripening device that is utilized as an outpatient procedure to misoprostol and dinoprostone as inpatient induction methods in a low risk cohort. METHODS: This is a retrospective comparative analysis of obstetric data on patients who presented for cervical ripening and labor induction. Ninety-six patients received a mechanical ripening agent as an outpatient procedure. As a control group, we used 99 patients with oral misoprostol (PGE1) and 42 patients with vaginal dinoprostone (PGE2) for cervical ripening in an inpatient setting. Data from 2016 until 2020 were analysed. RESULTS: Baseline characteristics showed no significant differences. Delivery modes were similar in all groups. The time period from patient admission to onset of labor was significantly shorter in the outpatient group (p<0.001): 10.9 h/0.5 days (±13.6/0.6) for osmotic dilator vs. 17.9 h/0.7 days (±13.1/0.5) for oral misoprostol vs. 21.8 h/0.8 days (±15.9/0.7) for vaginal dinoprostone. With 20.4 h/0.8 days (±14.3/0.6) the osmotic dilator group displayed significantly the shortest inpatient stay from admission to delivery (p=0.027). The patient subgroup of misoprostol had 25.7 h/1.1 days (±14.9/0.6) of inpatient stay from admission to delivery and the patient group of dinoprostone 27.5 h/1.1 days (±16.0/0.7). There were fewer hospital days in the outpatient group: 84.9 h/3.5 days vs. 88.9 h/3.7 days vs. 93.6 h/3.9 days (outpatient osmotic dilator vs. inpatient misoprostol and dinoprostone, respectively). CONCLUSIONS: New approaches are required to decrease individual contacts between patients and staff while maintaining a high quality patient care in obstetrics. This analysis reveals that outpatient mechanical cervical ripening can be as safe and effective as inpatient cervical ripening with PGE1/PGE2, while lowering patient-staff contact and total hospital stays and therefore decreasing the socioeconomic costs.


Subject(s)
COVID-19 , Misoprostol , Oxytocics , Pregnancy , Female , Humans , Cervical Ripening , Dinoprostone , Retrospective Studies , Alprostadil , Inpatients , Pandemics , Outpatients , SARS-CoV-2 , COVID-19/epidemiology , Labor, Induced/methods , Socioeconomic Factors , Administration, Intravaginal
10.
BMJ Sex Reprod Health ; 48(3): 185-192, 2022 07.
Article in English | MEDLINE | ID: covidwho-1932771

ABSTRACT

BACKGROUND: The Scottish government introduced legislation during the COVID-19 outbreak to permit medical abortion at home with telemedicine. All women received an initial telephone consultation. For those choosing medical abortion, we provided self-administered medications to eligible women with pregnancies under 12 weeks' gestation. AIMS: To assess adherence to the recommended abortion drug regimen, with particular focus on the number of misoprostol doses used and the interval between mifepristone and misoprostol administration and the induction-expulsion interval. Additionally, to evaluate use of analgesia, antiemetics and antibiotics, and the side effects, pain and bleeding profile of medical abortion at home. METHODS: We conducted a prospective cohort study of 663 women choosing medical abortion at home via telemedicine at an NHS abortion service in Edinburgh, Scotland between 1 April and 9 July 2020. Interviewer-administered questionnaires were completed at telephone follow-up 4 and 14 days following treatment. Outcome measures were self-reported and included use of mifepristone and misoprostol, induction-expulsion interval (time from misoprostol administration until expulsion of pregnancy), antiemetics, antibiotics, analgesia use, pain scores, rates of side effects, bleeding and preparedness for treatment. RESULTS: Among the respondents, 652/663 women (98%) answered at least one questionnaire, and 594/663 (89.6%) used both abortion medications as directed (24-72 hours between medications). The mean (SD) induction-expulsion interval was 4.3 (4.3) hours. Antiemetics were used by 611/663 (92%), 383/599 (64%) completed the course of prophylactic antibiotics, and 616/663 (93%) used analgesia, with mean (SD) worst-pain scores of 6.7 (2.2) out of 10. Regarding side effects, 510/663 (77%) experienced either nausea, vomiting, diarrhoea or headache, 101/663 (15%) experienced headache and 510/663 (77%) experienced bleeding that was heavier than a period; 554/663, (84%) felt prepared for their treatment by teleconsultation. CONCLUSION: Patients are able to correctly self-administer abortion medications following a telemedicine consultation. Further research is required to optimise pain management and gastrointestinal side effects during medical abortion.


Subject(s)
Abortion, Induced , Antiemetics , COVID-19 , Misoprostol , Telemedicine , Anti-Bacterial Agents , COVID-19/epidemiology , Female , Headache/etiology , Humans , Mifepristone/therapeutic use , Misoprostol/adverse effects , Pain/etiology , Pregnancy , Prevalence , Prospective Studies , Referral and Consultation , Telephone
11.
BMJ Sex Reprod Health ; 48(4): 288-294, 2022 10.
Article in English | MEDLINE | ID: covidwho-1807457

ABSTRACT

BACKGROUND: During the COVID-19 pandemic, the British governments issued temporary approvals enabling the use of both medical abortion pills, mifepristone and misoprostol, at home. This permitted the introduction of a fully telemedical model of abortion care with consultations taking place via telephone or video call and medications delivered to women's homes. The decision was taken by the governments in England and Wales to continue this model of care beyond the original end date of April 2022, while at time of writing the approval in Scotland remains under consultation. METHODS: We interviewed 30 women who had undergone an abortion in England, Scotland or Wales between August and December 2021. We explored their views on the changes in abortion service configuration during the pandemic and whether abortion via telemedicine and use of abortion medications at home should continue. RESULTS: Support for continuation of the permission to use mifepristone and misoprostol at home was overwhelmingly positive. Reasons cited included convenience, comfort, reduced stigma, privacy and respect for autonomy. A telemedical model was also highly regarded for similar reasons, but for some its necessity was linked to safety measures during the pandemic, and an option to have an in-person interaction with a health professional at some point in the care pathway was endorsed. CONCLUSIONS: The approval to use abortion pills at home via telemedicine is supported by women having abortions in Britain. The voices of patients are essential to shaping acceptable and appropriate abortion service provision.


Subject(s)
COVID-19 , Misoprostol , COVID-19/epidemiology , Female , Humans , Mifepristone/therapeutic use , Misoprostol/therapeutic use , Pandemics , Pregnancy , United Kingdom/epidemiology
12.
BMJ Sex Reprod Health ; 48(2): 146-148, 2022 04.
Article in English | MEDLINE | ID: covidwho-1784852
13.
BMJ ; 376: o819, 2022 03 29.
Article in English | MEDLINE | ID: covidwho-1769885
15.
Am J Obstet Gynecol ; 226(5): 710.e1-710.e21, 2022 05.
Article in English | MEDLINE | ID: covidwho-1588396

ABSTRACT

BACKGROUND: Mifepristone, used together with misoprostol, is approved by the United States Food and Drug Administration for medication abortion through 10 weeks' gestation. Although in-person ultrasound is frequently used to establish medication abortion eligibility, previous research demonstrates that people seeking abortion early in pregnancy can accurately self-assess gestational duration using the date of their last menstrual period. OBJECTIVE: In this study, we establish the screening performance of a broader set of questions for self-assessment of gestational duration among a sample of people seeking abortion at a wide range of gestations. STUDY DESIGN: We surveyed patients seeking abortion at 7 facilities before ultrasound and compared self-assessments of gestational duration using 11 pregnancy dating questions with measurements on ultrasound. For individual pregnancy dating questions and combined questions, we established screening performance focusing on metrics of diagnostic accuracy, defined as the area under the receiver operating characteristic curve, sensitivity (or the proportion of ineligible participants who correctly screened as ineligible for medication abortion), and proportion of false negatives (ie, the proportion of all participants who erroneously screened as eligible for medication abortion). We tested for differences in sensitivity across individual and combined questions using McNemar's test, and for differences in accuracy using the area under the receiver operating curve and Sidak adjusted P values. RESULTS: One-quarter (25%) of 1089 participants had a gestational duration of >70 days on ultrasound. Using the date of last menstrual period alone demonstrated 83.5% sensitivity (95% confidence interval, 78.4-87.9) in identifying participants with gestational durations of >70 days on ultrasound, with an area under the receiver operating characteristic curve of 0.82 (95% confidence interval, 0.79-0.85) and a proportion of false negatives of 4.0%. A composite measure of responses to questions on number of weeks pregnant, date of last menstrual period, and date they got pregnant demonstrated 89.1% sensitivity (95% confidence interval, 84.7-92.6) and an area under the receiver operating curve of 0.86 (95% confidence interval, 0.83-0.88), with 2.7% of false negatives. A simpler question set focused on being >10 weeks or >2 months pregnant or having missed 2 or more periods had comparable sensitivity (90.7%; 95% confidence interval, 86.6-93.9) and proportion of false negatives (2.3%), but with a slightly lower area under the receiver operating curve (0.82; 95% confidence interval, 0.79-0.84). CONCLUSION: In a sample representative of people seeking abortion nationally, broadening the screening questions for assessing gestational duration beyond the date of the last menstrual period resulted in improved accuracy and sensitivity of self-assessment at the 70-day threshold for medication abortion. Ultrasound assessment for medication abortion may not be necessary, especially when requiring ultrasound could increase COVID-19 risk or healthcare costs, restrict access, or limit patient choice.


Subject(s)
Abortion, Induced , Abortion, Spontaneous , COVID-19 , Misoprostol , Abortion, Induced/methods , Abortion, Spontaneous/drug therapy , Female , Gestational Age , Humans , Mifepristone/therapeutic use , Misoprostol/therapeutic use , Pregnancy , Self-Assessment
16.
Lancet Glob Health ; 10(1): e105-e113, 2022 01.
Article in English | MEDLINE | ID: covidwho-1586172

ABSTRACT

BACKGROUND: Clinical trials have established the high effectiveness and safety of medication abortion in clinical settings. However, barriers to clinical abortion care have shifted most medication abortion use to out-of-clinic settings, especially in the context of the COVID-19 pandemic. Given this shift, we aimed to estimate the effectiveness of self-managed medication abortion (medication abortion without clinical support), and to compare it to effectiveness of clinician-managed medication abortion. METHODS: For this prospective, observational cohort study, we recruited callers from two safe abortion accompaniment groups in Argentina and Nigeria who requested information on self-managed medication abortion. Before using one of two medication regimens (misoprostol alone or in combination with mifepristone), participants completed a baseline survey, and then two follow-up phone surveys at 1 week and 3 weeks after taking pills. The primary outcome was the proportion of participants reporting a complete abortion without surgical intervention. Legal restrictions precluded enrolment of a concurrent clinical control group; thus, a non-inferiority analysis compared abortion completion among those in our self-managed medication abortion cohort with abortion completion reported in historical clinical trials using the same medication regimens, restricted to participants with pregnancies of less than 9 weeks' gestation. This study was registered with ISCRTN, ISRCTN95769543. FINDINGS: Between July 31, 2019, and April 27, 2020, we enrolled 1051 participants. We analysed abortion outcomes for 961 participants, with an additional 47 participants reached after the study period. Most pregnancies were less than 12 weeks' duration. Participants in follow-up self-managed their abortions using misoprostol alone (593 participants) or the combined regimen of misoprostol plus mifepristone (356 participants). At last follow-up, 586 (99%) misoprostol alone users and 334 (94%) combined regimen users had a complete abortion without surgical intervention. For those with pregnancies of less than 9 weeks' gestation, both regimens were non-inferior to medication abortion effectiveness in clinical settings. INTERPRETATION: Findings from this prospective cohort study show that self-managed medication abortion with accompaniment group support is highly effective and, for those with pregnancies of less than 9 weeks' gestation, non-inferior to the effectiveness of clinician-managed medication abortion administered in a clinical setting. These findings support the use of remote self-managed models of early abortion care, as well as telemedicine, as is being considered in several countries because of the COVID-19 pandemic. FUNDING: David and Lucile Packard Foundation. TRANSLATIONS: For the Arabic, French, Bahasa Indonesian, Spanish and Yoruba translations of the Article see Supplementary Materials section.


Subject(s)
Abortion, Induced , Self Administration , Self-Management/methods , Abortifacient Agents/administration & dosage , Argentina , COVID-19 , Cohort Studies , Female , Humans , Mifepristone/administration & dosage , Misoprostol/administration & dosage , Nigeria , Pregnancy , Prospective Studies , Surveys and Questionnaires
18.
Cochrane Database Syst Rev ; 6: CD014484, 2021 06 22.
Article in English | MEDLINE | ID: covidwho-1453529

ABSTRACT

BACKGROUND: Misoprostol given orally is a commonly used labour induction method. Our Cochrane Review is restricted to studies with low-dose misoprostol (initially ≤ 50 µg), as higher doses pose unacceptably high risks of uterine hyperstimulation. OBJECTIVES: To assess the efficacy and safety of low-dose oral misoprostol for labour induction in women with a viable fetus in the third trimester of pregnancy. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov,  the WHO International Clinical Trials Registry Platform (14 February 2021) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised trials comparing low-dose oral misoprostol (initial dose ≤ 50 µg) versus placebo, vaginal dinoprostone, vaginal misoprostol, oxytocin, or mechanical methods; or comparing oral misoprostol protocols (one- to two-hourly versus four- to six-hourly; 20 µg to 25 µg versus 50 µg; or 20 µg hourly titrated versus 25 µg two-hourly static). DATA COLLECTION AND ANALYSIS: Using Covidence, two review authors independently screened reports, extracted trial data, and performed quality assessments. Our primary outcomes were vaginal birth within 24 hours, caesarean section, and hyperstimulation with foetal heart changes. MAIN RESULTS: We included 61 trials involving 20,026 women. GRADE assessments ranged from moderate- to very low-certainty evidence, with downgrading decisions based on imprecision, inconsistency, and study limitations. Oral misoprostol versus placebo/no treatment (four trials; 594 women) Oral misoprostol may make little to no difference in the rate of caesarean section (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.59 to 1.11; 4 trials; 594 women; moderate-certainty evidence), while its effect on uterine hyperstimulation with foetal heart rate changes is uncertain (RR 5.15, 95% CI 0.25 to 105.31; 3 trials; 495 women; very low-certainty evidence). Vaginal births within 24 hours was not reported. In all trials, oxytocin could be commenced after 12 to 24 hours and all women had pre-labour ruptured membranes. Oral misoprostol versus vaginal dinoprostone (13 trials; 9676 women) Oral misoprostol probably results in fewer caesarean sections (RR 0.84, 95% CI 0.78 to 0.90; 13 trials, 9676 women; moderate-certainty evidence). Subgroup analysis indicated that 10 µg to 25 µg (RR 0.80, 95% CI 0.74 to 0.87; 9 trials; 8652 women) may differ from 50 µg (RR 1.10, 95% CI 0.91 to 1.34; 4 trials; 1024 women) for caesarean section. Oral misoprostol may decrease vaginal births within 24 hours (RR 0.93, 95% CI 0.87 to 1.00; 10 trials; 8983 women; low-certainty evidence) and hyperstimulation with foetal heart rate changes (RR 0.49, 95% CI 0.40 to 0.59; 11 trials; 9084 women; low-certainty evidence). Oral misoprostol versus vaginal misoprostol (33 trials; 6110 women) Oral use may result in fewer vaginal births within 24 hours (average RR 0.81, 95% CI 0.68 to 0.95; 16 trials, 3451 women; low-certainty evidence), and less hyperstimulation with foetal heart rate changes (RR 0.69, 95% CI 0.53 to 0.92, 25 trials, 4857 women, low-certainty evidence), with subgroup analysis suggesting that 10 µg to 25 µg orally (RR 0.28, 95% CI 0.14 to 0.57; 6 trials, 957 women) may be superior to 50 µg orally (RR 0.82, 95% CI 0.61 to 1.11; 19 trials; 3900 women). Oral misoprostol probably does not increase caesarean sections overall (average RR 1.00, 95% CI 0.86 to 1.16; 32 trials; 5914 women; low-certainty evidence) but likely results in fewer caesareans for foetal distress (RR 0.74, 95% CI 0.55 to 0.99; 24 trials, 4775 women). Oral misoprostol versus intravenous oxytocin (6 trials; 737 women, 200 with ruptured membranes) Misoprostol may make little or no difference to vaginal births within 24 hours (RR 1.12, 95% CI 0.95 to 1.33; 3 trials; 466 women; low-certainty evidence), but probably results in fewer caesarean sections (RR 0.67, 95% CI 0.50 to 0.90; 6 trials; 737 women; moderate-certainty evidence). The effect on hyperstimulation with foetal heart rate changes is uncertain (RR 0.66, 95% CI 0.19 to 2.26; 3 trials, 331 women; very low-certainty evidence). Oral misoprostol versus mechanical methods (6 trials; 2993 women) Six trials compared oral misoprostol to transcervical Foley catheter. Misoprostol may increase vaginal birth within 24 hours (RR 1.32, 95% CI 0.98 to 1.79; 4 trials; 1044 women; low-certainty evidence), and probably reduces the risk of caesarean section (RR 0.84, 95% CI 0.75 to 0.95; 6 trials; 2993 women; moderate-certainty evidence). There may be little or no difference in hyperstimulation with foetal heart rate changes (RR 1.31, 95% CI 0.78 to 2.21; 4 trials; 2828 women; low-certainty evidence). Oral misoprostol one- to two-hourly versus four- to six-hourly (1 trial; 64 women) The evidence on hourly titration was very uncertain due to the low numbers reported. Oral misoprostol 20 µg hourly titrated versus 25 µg two-hourly static (2 trials; 296 women) The difference in regimen may have little or no effect on the rate of vaginal births in 24 hours (RR 0.97, 95% CI 0.80 to 1.16; low-certainty evidence). The evidence is of very low certainty for all other reported outcomes. AUTHORS' CONCLUSIONS: Low-dose oral misoprostol is probably associated with fewer caesarean sections (and therefore more vaginal births) than vaginal dinoprostone, and lower rates of hyperstimulation with foetal heart rate changes. However, time to birth may be increased, as seen by a reduced number of vaginal births within 24 hours. Compared to transcervical Foley catheter, low-dose oral misoprostol is associated with fewer caesarean sections, but equivalent rates of hyperstimulation. Low-dose misoprostol given orally rather than vaginally is probably associated with similar rates of vaginal birth, although rates may be lower within the first 24 hours. However, there is likely less hyperstimulation with foetal heart changes, and fewer caesarean sections performed due to foetal distress. The best available evidence suggests that low-dose oral misoprostol probably has many benefits over other methods for labour induction. This review supports the use of low-dose oral misoprostol for induction of labour, and demonstrates the lower risks of hyperstimulation than when misoprostol is given vaginally. More trials are needed to establish the optimum oral misoprostol regimen, but these findings suggest that a starting dose of 25 µg may offer a good balance of efficacy and safety.


Subject(s)
Labor, Induced/methods , Misoprostol/administration & dosage , Oxytocics/administration & dosage , Administration, Intravaginal , Administration, Oral , Apgar Score , Cesarean Section/statistics & numerical data , Dinoprostone/administration & dosage , Drug Administration Schedule , Female , Heart Rate, Fetal/drug effects , Humans , Intensive Care, Neonatal/statistics & numerical data , Oxytocin/administration & dosage , Parturition , Placebos/administration & dosage , Pregnancy , Randomized Controlled Trials as Topic , Time Factors , Uterus/drug effects
19.
BJOG ; 128(11): 1752-1761, 2021 10.
Article in English | MEDLINE | ID: covidwho-1429453

ABSTRACT

OBJECTIVE: To explore the experiences of women in Scotland who accessed medical abortion at home up to 12 weeks' gestation, delivered via a telemedicine abortion service implemented in response to the coronavirus (COVID-19) pandemic, to identify areas for improvement and inform service provision. DESIGN: Qualitative interview study. SETTING: Abortion service in one National Health Service health board in Scotland. POPULATION OR SAMPLE: Twenty women who accessed telemedicine abortion services and self-administered mifepristone and misoprostol at home up to 12 weeks' gestation. METHODS: Thematic analysis of semi-structured qualitative interviews, informed by the Framework analytic approach. MAIN OUTCOME MEASURES: Women's experiences of accessing telemedicine for medical abortion at home, specifically: acceptability of the telephone consultation and remote support; views on no pre-abortion ultrasound scan; and self-administration of abortion medications at home. RESULTS: Novel study findings were three-fold: (1) participants valued the option of accessing abortion care via telemedicine and emphasised the benefits of providing a choice of telephone and in-person consultation to suit those with different life circumstances; (2) the quality of abortion care was enhanced by the telemedicine service in relation to access, comfort and flexibility, and ongoing telephone support; (3) participants described being comfortable with, and in some cases a preference for, not having an ultrasound scan. CONCLUSIONS: This research demonstrates support for the continuation of telemedicine abortion services beyond the temporary arrangements in place during COVID-19, and lends weight to the argument that offering the option of telemedicine abortion care can enable women to access this essential health service. TWEETABLE ABSTRACT: #Telemedicine provision of medical #abortion at home up to 12 weeks' gestation is acceptable and highly valued by #women #Research #SRHR @nbw80 @doctorjjrw @jeniharden @cameronsharon @mrc_crh @edinuniusher.


Subject(s)
Abortifacient Agents, Nonsteroidal/administration & dosage , Abortion, Induced/methods , Patient Satisfaction , Self Administration/psychology , Telemedicine/methods , Abortion, Induced/psychology , Adult , COVID-19 , Female , Health Services Accessibility , Humans , Mifepristone/administration & dosage , Misoprostol/administration & dosage , Pregnancy , Qualitative Research , SARS-CoV-2 , Scotland , State Medicine
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