Disseminated Intravascular Coagulation and Hemorrhage After Dilation and Evacuation Abortion for Fetal Death.

OBJECTIVE: To examine the association between fetal death and risk of hemorrhage and disseminated intravascular coagulation (DIC) among women undergoing dilation and evacuation (D&E) procedures. METHODS: We conducted a retrospective cohort study of all D&Es at one academic abortion clinic in San Francisco between 2009 and 2013. We abstracted data on fetal death status, demographic characteristics, and complications including hemorrhage and DIC. We examined the risk of hemorrhage and DIC among women with fetal death compared with those without. We conducted unadjusted and adjusted analyses for the outcomes of hemorrhage, DIC, and any complication. RESULTS: Among 92 cases of D&E for fetal death and 4,428 cases of D&E for other reasons, hemorrhage occurred in 10% and 7%, respectively (P=.28), and DIC occurred in 2.0% and 0.2% of the fetal death and nonfetal death cohorts (P<.001). In adjusted analysis, fetal death was associated with 2.9 times higher odds of hemorrhage (95% CI 1.4-6.0). In an unadjusted analysis, fetal death was associated with 12.3 times higher odds of DIC (95% CI 2.6-58.6) and 3.0 times higher odds of any complication (95% CI 1.6-5.9). CONCLUSION: Women undergoing D&E for fetal death are far more likely to experience DIC and hemorrhage than are women without fetal death, yet the absolute risk is low (2%). Although D&E providers should be prepared for DIC and hemorrhage, we do not recommend any specific preoperative preparation because the vast majority of D&E abortions for fetal death are uncomplicated.

Cluster randomized trial of a patient-centered contraceptive decision support tool, My Birth Control.

BACKGROUND: Research suggests the need for improvement in the patient-centeredness and comprehensiveness of contraceptive counseling. My Birth Control is a tablet-based decision support tool designed to improve women's experience of contraceptive counseling and to help them select contraceptive methods that are consistent with their values and preferences. OBJECTIVE: The objective of this study was to evaluate the effect of My Birth Control on contraceptive continuation, experience of contraceptive care, and decision quality. STUDY DESIGN: Using a cluster randomized design, randomized at the provider level, patient participants interested in starting or changing contraception interacted with My Birth Control before their family planning visit (intervention) or received usual care (control). A postvisit survey assessed experience of care method satisfaction, decision quality, and contraceptive knowledge. Surveys at 4 and 7 months assessed the primary outcome of contraceptive continuation, along with method use, satisfaction, and unintended pregnancy. Mixed-effects logistic regression models with multiple imputation for missing data were used to examine the effect of treatment assignment. RESULTS: Twenty-eight providers participated and 758 patients enrolled between December 5, 2014, and February 5, 2016. Participants were racially/ethnically diverse; less than a quarter self-identified as white. No effect was found on 7-month continuation (56.6% and 59.6% for intervention and control group respectively, odds ratio, 0.89; 95% confidence interval, 0.65-1.22). However, assignment to the intervention group increased reporting of the greatest Interpersonal Quality of Family Planning score (66.0% vs 57.4%, odds ratio, 1.45; 95% confidence interval, 1.03-2.05), the greatest scores on the informed decision and uncertainty subscales of the Decisional Conflict Scale (50.5% vs 43.2%, odds ratio, 1.34; 95% confidence interval, 1.0-1.80 and 41.6% vs 33.3%, odds ratio, 1.45; 95% confidence interval, 1.03-2.05), and greater knowledge. CONCLUSION: My Birth Control had no effect on contraceptive continuation. The intervention did enhance the experience of contraceptive counseling and informed decision making, as well as contraceptive knowledge., The intervention's effect on patient experience is important, particularly given the personal nature of contraceptive decision making and the social and historical context of family planning care.

Safety of Deep Sedation Without Intubation for Second-Trimester Dilation and Evacuation.

OBJECTIVE: To estimate the incidence of pulmonary aspiration and other anesthesia-related adverse events in women undergoing dilation and evacuation (D&E) under intravenous deep sedation without tracheal intubation in an outpatient setting. METHODS: We reviewed all D&Es done under anesthesiologist-administered intravenous deep sedation without tracheal intubation between February 2009 and April 2013. The study's primary outcome was pulmonary aspiration; secondary outcomes included other anesthesia-related complications. We calculated the incidence of anesthesia-related adverse events as well as a 95% CI around the point estimate. RESULTS: During the 51-month study period, 4,481 second-trimester abortions were completed. Of these, 2,523 (56%) were done under deep sedation without tracheal intubation, 652 (26%) between 14 and 19 6/7 weeks of gestation, and 1,871 (74%) between 20 and 24 weeks of gestation. Seven cases of anesthesia-related complications were identified: two cases of pulmonary aspiration (0.08%, 95% CI 0.01-0.29%), four cases of upper airway obstruction (0.016%, 95% CI 0.04-0.41%), and one case of lingual nerve injury (0.04%, 95% CI 0.001-0.22%). CONCLUSION: Deep sedation without tracheal intubation for women undergoing D&E has a low incidence of anesthesia-related complications.

Immediate versus delayed postpartum use of levonorgestrel contraceptive implants: a randomized controlled trial in Uganda.

BACKGROUND: Use of long-acting, highly effective contraception has the potential to improve women's ability to avoid short interpregnancy intervals, which are associated with an increased risk of maternal morbidity and mortality, and preterm delivery. In Uganda, contraceptive implants are not routinely available during the immediate postpartum period. OBJECTIVE: The purpose of this study was to compare the proportion of women using levonorgestrel contraceptive implants at 6 months after delivery in women randomized to immediate or delayed insertion. STUDY DESIGN: This was a randomized controlled trial among women in Kampala, Uganda. Women who desired contraceptive implants were randomly assigned to insertion of a 2-rod contraceptive implant system containing 75 mg of levonorgestrel immediately following delivery (within 5 days of delivery and before discharge from the hospital) or delayed insertion (6 weeks postpartum). The primary outcome was implant utilization at 6 months postpartum. RESULTS: From June to October 2015, 205 women were randomized, 103 to the immediate group and 102 to the delayed group. Ninety-three percent completed the 6 month follow-up visit. At 6 months, implant use was higher in the immediate group compared with the delayed group (97% vs 68%; P < .001), as was the use of any highly effective contraceptive (98% vs 81%; P = .001). Women in the immediate group were more satisfied with the timing of implant placement. If given the choice, 81% of women in the immediate group and 63% of women in the delayed group would choose the same timing of placement again (P = .01). There were no serious adverse events in either group. CONCLUSION: Offering women the option of initiating contraceptive implants in the immediate postpartum period has the potential to increase contraceptive utilization, decrease unwanted pregnancies, prevent short interpregnancy intervals, and help women achieve their reproductive goals.

Choice of the levonorgestrel intrauterine device, etonogestrel implant or depot medroxyprogesterone acetate for contraception after aspiration abortion.

OBJECTIVE: Women who have abortions are at high risk of contraception discontinuation and subsequent unintended pregnancy. The objective of this analysis was to identify factors associated with choice of highly effective, long-acting, progestin-only contraceptive methods after abortion. STUDY DESIGN: Women presenting for surgical abortion who selected the levonorgestrel intrauterine device (IUD), the progestin implant or the progestin injection (depot medroxyprogesterone acetate or DMPA) as their postabortion contraceptives were recruited to participate in a 1-year prospective cohort study. We used multivariable multinomial logistic regression to identify factors associated with choosing long-acting reversible contraceptives (IUD or implant) compared to DMPA. RESULTS: A total of 260 women, aged 18-45 years, enrolled in the study, 100 of whom chose the IUD, 63 the implant and 97 the DMPA. The women were 24.9 years old on average; 36% were black, and 29% were Latina. Fifty-nine percent had had a previous abortion, 66% a prior birth, and 55% were undergoing a second-trimester abortion. In multivariable analyses, compared with DMPA users, women who chose the IUD or the implant were less likely to be currently experiencing intimate partner violence (IPV); reported higher stress levels; weighed more; and were more likely to have finished high school, to have used the pill before and to report that counselors or doctors were helpful in making the decision (all significant at p<.05, see text for relative risk ratios and confidence intervals.) In addition, women who chose the IUD were less likely to be black (p<.01), and women who chose the implant were more likely to report that they would be unhappy to become pregnant within 6 months (p<.05) than DMPA users. CONCLUSION: A variety of factors including race/ethnicity, past contraceptive use, feelings towards pregnancy, stress and weight were different between LARC and DMPA users. Notably, current IPV was associated with choice of DMPA over the IUD or implant, implying that a desire to choose a hidden method may be important to some women and should be included in counseling. IMPLICATIONS: In contraceptive counseling, after screening for IPV, assessing patient's stress and taking a history about past contraceptive use, clinicians should discuss whether these factors might affect a patient's choice of method.

Buccal misoprostol plus laminaria for cervical preparation before dilation and evacuation at 21-23 weeks of gestation: a randomized controlled trial.

OBJECTIVE: To describe the effectiveness of buccal misoprostol as an adjunct to laminaria for cervical ripening before later second-trimester abortion by dilation and evacuation (D&E). METHODS: A randomized, double-blinded, placebo-controlled trial of 196 women undergoing D&E between 21 and 23 weeks of gestation. Subjects had overnight laminaria and 400 mcg buccal misoprostol or placebo 3-4 h before the abortion. We used logarithmic transformation of the primary outcome--D&E procedure duration--to achieve a normal distribution. RESULTS: Mean D&E duration was 1.7 min shorter with misoprostol (p=.02). The median duration was 9.7 versus 10.4 min in the misoprostol and placebo groups, respectively (p=.09). Cervical dilation was slightly greater with misoprostol (median 75 mm vs. 73 mm, p=.04); however, physicians did not find the misoprostol D&Es easier to complete. Half of subjects reported severe pain after misoprostol vs. 11% with placebo (p<.001). CONCLUSION: Adjuvant buccal misoprostol results in slightly shorter D&Es at the cost of more side effects.

Same-day synthetic osmotic dilators compared with overnight laminaria before abortion at 14-18 weeks of gestation: a randomized controlled trial.

OBJECTIVE: To increase access to early second-trimester surgical abortion by determining noninferiority of same-day synthetic osmotic dilators compared with overnight Laminaria for cervical preparation before early second-trimester dilation and evacuation. METHODS: We enrolled women between 14 and 18 weeks of gestation and randomized them to same-day synthetic osmotic dilators or overnight Laminaria. Study participants and clinicians were blinded to group assignment. The primary outcome was procedure duration. The trial was powered to assess noninferiority of synthetic osmotic dilators to exclude a mean difference of 5 minutes or longer. RESULTS: We enrolled 72 patients: 36 were randomized to same-day synthetic osmotic dilators and 36 to overnight Laminaria. Mean procedure duration was 8.1 and 5.9 minutes, respectively, with a mean difference of 2.1 minutes (97.5% confidence interval -0.3 to 4.5). Same-day synthetic osmotic dilators resulted in less initial cervical dilation than overnight Laminaria (mean circumference 48 compared with 60 mm Pratt, P<.001) and required more mechanical dilation (69% compared with 27%, P=.001). There was no difference in complications, all of which were minor, or in the median procedural difficulty score rated by physicians. Most patients in both groups would choose a same-day procedure if necessary in the future. CONCLUSION: Despite less initial cervical dilation and a greater need for mechanical dilation, same-day synthetic osmotic dilators are not inferior to overnight Laminaria with respect to procedure duration. Same-day osmotic dilation is preferred by patients and may be a reasonable alternative to overnight Laminaria for cervical preparation before early second-trimester dilation and evacuation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00775983. LEVEL OF EVIDENCE: I.

Immediate versus delayed initiation of the contraceptive patch after abortion: a randomized trial.

BACKGROUND: Immediate start of the contraceptive patch has not been studied in women after surgical abortion. STUDY DESIGN: Women presenting for surgical abortion who had chosen the transdermal patch for contraception were randomized to either delayed start of the patch (beginning the Sunday after their abortion) or immediate start (directly observed application of the patch in the clinic). Subjects were contacted at 2 and 6 months to assess contraceptive use. RESULTS: Two hundred ninety-eight women were randomized, and the follow-up rate was 71% at 2 months and 53% at 6 months. Method continuation did not differ by timing of initiation. At 2 months, 71% in the delayed-start group and 74% in the immediate-start group were using the patch [p=.6, with a difference of 3.1%, 95% confidence interval (CI)=-17.2% to +11.2%]. At 6 months, 55% in the delayed-start group and 43% in the immediate-start group were using the patch (p=.13, with a difference of 11.9%, 95% CI=-19.2% to +34%). CONCLUSION: Immediate initiation of the contraceptive patch after surgical abortion was not associated with increased use of patch at 2 or 6 months.

An over-the-counter simulation study of a single-tablet emergency contraceptive in young females.

OBJECTIVES: To evaluate use of a single-tablet (levonorgestrel 1.5 mg) emergency contraceptive administered to young females under simulated over-the-counter conditions. Secondary objectives were to assess repeat use, pregnancy, and adverse events. METHODS: Females aged 11-17 years requesting emergency contraception at teen reproductive health clinics in five cities were eligible to participate. Participants read the study product label and determined whether and how to use the product without interacting with providers. Study product was dispensed to participants who appropriately selected to use it; participants were contacted 1, 4, and 8 weeks later to assess use, pregnancy, and adverse events. The incidences of outcomes were calculated and regression analysis was used to assess the effect of age and use status (ever used or no previous use) on primary outcomes. RESULTS: Of the 345 females enrolled, 279 were younger than age 17 years. Among the 340 participants included in the selection analysis, 311 (91.5%) (97.5% confidence interval 87.5- 94.5%) participants appropriately selected to use or not use product. Among the 298 participants who used product, 274 (92.9%) (97.5% confidence interval 88.8-95.8%) correctly used it as labeled. Selection and correct use were not associated with age. Fifty-seven participants (18.8%) used additional emergency contraception over the study period and seven (2.3%) participants who used product became pregnant; there were no unusual adverse events. CONCLUSION: Restricting young females' use of a single-tablet emergency contraceptive by prescription only is not warranted, because females younger than 17 years can use it in a manner consistent with over-the-counter access. LEVEL OF EVIDENCE: II.

Contraceptive discontinuation and repeat unintended pregnancy within 1 year after an abortion.

BACKGROUND: We examined 12-month hormonal contraceptive continuation and pregnancy rates by abortion history. STUDY DESIGN: Women who wanted to avoid pregnancy for at least 1 year were recruited at four San Francisco Bay area family planning clinics on regular service days and on abortion care days. Participants completed baseline and follow-up questionnaires. Multivariable Cox models assessed the factors associated with method discontinuation and pregnancy. RESULTS: Women who were enrolled into the study on the day of their abortion were 20% more likely to discontinue their contraceptive method than women who never had an abortion [adjusted hazard ratio (AHR)=1.21, 95% confidence interval (CI)=1.03-1.42]. Women who had a recent abortion or previous abortion were 60% more likely to have a pregnancy during follow-up than women who never had an abortion (AHR=1.63, 95% CI =1.21-2.20, and AHR=1.66, 95% CI=1.18-2.33, respectively). CONCLUSION: The experience of having an unintended pregnancy and abortion does not lead to behavioral changes that protect against another unintended pregnancy.

One-year contraceptive continuation and pregnancy in adolescent girls and women initiating hormonal contraceptives.

OBJECTIVE: To assess contraceptive discontinuation, switching, factors associated with method discontinuation, and pregnancy among women initiating hormonal contraceptives. METHODS: This was a 12-month longitudinal cohort study of adolescent girls and women (n=1,387) aged 15 to 24 years attending public family planning clinics who did not desire pregnancy for at least 1 year and selected to initiate the patch, ring, depot medroxyprogesterone acetate, or pills. Participants completed follow-up assessments at 3, 6, and 12 months after baseline. Life table analysis was used to estimate survival rates for contraceptive continuation. Cox proportional hazards models were used to estimate factors associated with method discontinuation. RESULTS: The continuation rate (per 100 person-years) at 12 months was low for all methods; however, it was lowest for patch and depot medroxyprogesterone acetate initiators, 10.9 and 12.1 per 100 person years, respectively (P≤.003); continuation among ring initiators was comparable to pill initiators, 29.4 and 32.7 per 100 person-years, respectively (P=.06). Discontinuation was independently associated with method initiated and younger age. The only factors associated with lower risk of discontinuation were greater intent to use the method and being in school or working. The pregnancy rate (per 100 person-years) was highest for patch and ring initiators (30.1 and 30.5) and comparable for pill and depot medroxyprogesterone acetate initiators (16.5 and 16.1; P<.001). CONCLUSION: The patch and the ring may not be better options than the pill or depot medroxyprogesterone acetate for women at high risk for unintended pregnancy. This study highlights the need for counseling interventions to improve contraceptive continuation, education about longer-acting methods, and developing new contraceptives that women may be more likely to continue. LEVEL OF EVIDENCE: II.

Impact of an intervention to improve contraceptive use through follow-up phone calls to female adolescent clinic patients.

CONTEXT: Adolescent females often have questions or concerns about their contraceptive methods, and they may discontinue use if these questions are not answered. Little evidence exists on whether follow-up phone calls to address young women's concerns can help sustain contraceptive use. METHODS: Between 2005 and 2007, a total of 805 females aged 14-18 attending a reproductive health clinic in San Francisco were randomly assigned to receive either regular clinic services or regular clinic services plus nine follow-up phone calls over 12 months. The young women were surveyed at baseline and roughly six, 12 and 18 months later to measure condom and contraceptive use, rates of pregnancy and STDs, and other outcomes and mediators. Multiple linear and logistic regression repeated measures analyses were used to assess the program's effects. RESULTS: Clinic counselors completed only 2.7 calls per patient, and made 7.8 attempts for every completed call. Although contraceptive use increased from baseline to follow-up at six months in both groups, levels of condom and contraceptive use, and rates of pregnancy and STDs, did not differ between the intervention and control groups at any of the follow-up assessments. Moreover, the intervention did not improve clinic utilization or satisfaction or have consistent positive effects on participants' attitudes. CONCLUSIONS: Reaching young women by phone after a clinic visit for contraception is challenging and does not appear to provide significant benefits beyond those provided by basic clinic services. More intensive interventions may be needed to markedly change adolescent sexual and contraceptive behavior.

Attitudes and beliefs about the intrauterine device among teenagers and young women.

BACKGROUND: Little is known about attitudes and beliefs among teenagers and young women about the intrauterine device (IUD). STUDY DESIGN: We surveyed 252 women, ages 14-27 years, presenting for appointments at an urban family planning clinic about demographics, sexual and birth control history, and opinions about the IUD. RESULTS: Fifty-five percent had not heard of the IUD. Participants who were parous were 4.4 times more likely to be interested in the IUD than nulliparous participants. Independent of parity, participants who had heard of the IUD from a health care provider were 2.7 times more likely to be interested in using the method. The study population was at high risk for sexually transmitted infections (STIs); however, 82% of participants predicted that they would increase or experience no change in their condom use with an IUD in place. CONCLUSIONS: Health care providers should be encouraged to talk to teenagers and young women who are at high risk for unintended pregnancy, both parous and nulliparous, about using the IUD.

Insertion of intrauterine contraceptives immediately following first- and second-trimester abortions.

BACKGROUND: The study was conducted to assess the continuation and patient satisfaction with intrauterine contraception (IUC) insertion immediately after elective abortion in the first and second trimesters in an urban, public hospital-based clinic. STUDY DESIGN: A cohort of 256 women who elected to have insertion of a copper-T IUC (CuT380a) or a levonorgestrel-releasing IUC (LNG-IUC) were followed postoperatively by phone calls or chart review to evaluate satisfaction and continuation with the method. RESULTS: Of our 256 subjects, 123 had first-trimester abortions and 133 had second-trimester abortions (14 or more weeks). Median time to follow-up was 8 weeks (range 7-544 days). Nineteen discontinuations occurred: eight (6.5%, 95% CI 2.8-12.4%) following first-trimester and 11 (8.3%, 95% CI 4.2-14.3%) following second-trimester abortion (p=.6). Five women reported expulsion; one (0.8%, 95% CI 0.0-4.4%) in the first-trimester group and four (3.0%, 95% CI 0.8-7.5%) in the second-trimester group. (p=.4) Seven infections resulting in discontinuation occurred (2.7%, 95% CI 1.1-5.6%); none were positive for gonorrhea or chlamydia at time of insertion. No perforations occurred. Nearly all (93.8%) of the women were satisfied with IUC. Rates of satisfaction between women after first- and second-trimester abortions were equal. CONCLUSION: In an urban clinic, IUC has high initial continuation and high patient satisfaction when inserted immediately following either first- or second-trimester abortions.