Medical management of early pregnancy loss with mifepristone and misoprostol in emergency departments compared to a Complex Family Planning office: Implementation of a COVID-19 institutional policy change.

OBJECTIVES: To evaluate the implementation of mifepristone and misoprostol for medical management of early pregnancy loss (EPL) in emergency departments (EDs) by comparing efficacy, complication, and follow-up rates for patients treated in EDs to the Complex Family Planning (CFP) outpatient office. STUDY DESIGN: In COVID-19's first wave, we expanded medical management of EPL to our EDs. This retrospective study evaluated 72 patients receiving mifepristone and misoprostol for EPL from April 1, 2020 to March 31, 2021, comparing treatment success, safety outcomes, and follow-up rates by location. RESULTS: Thirty-three (46%) patients received care in the ED and 39 (54%) at CFP. Treatment success was lower in EDs (23, 70%) compared to CFP (34, 87%), but after adjusting for insurance status and pregnancy type (miscarriage, uncertain viability, unknown location), this was not significant: adjusted odds ratio 0.48 (95% CI 0.13-1.81). More ED patients underwent emergent interventions (3 vs 0) including two emergent uterine aspirations, one uterine artery embolization, and two blood transfusions. Two cases were attributed to misdiagnosis (cesarean scar and cervical ectopic pregnancies interpreted as incomplete miscarriages) and one to guideline nonadherence. No complications occurred in the CFP group. Follow-up rates were over 80% in both groups. More ED patients engaged in telehealth follow-up (67% vs 18%, p ≤ 0.0001). CONCLUSIONS: In this small sample, we observed a trend toward less successful treatment in the ED compared to the CFP office. Both correctly making uncommon diagnoses and adhering to new guidelines presented implementation challenges. IMPLICATIONS: Implementing mifepristone and misoprostol for EPL in our EDs achieved lower rates of pregnancy resolution compared to outpatient management. Complex uncommon diagnoses and implementing new care pathways in EDs may have contributed to complications and highlighted opportunities for improvement. Additional studies are needed to further quantify safety outcomes for EPL management in EDs.

Impact of Group Prenatal Care on Contraceptive Use at Twelve Weeks Postpartum.

OBJECTIVES: To compare the prevalence of highly effective contraceptive use by 12 weeks postpartum among participants of Centering Pregnancy®, a model of group prenatal care (GPC), and traditional prenatal care (TPC), and to investigate differences in contraceptive method choice by type of prenatal care. METHODS: We performed a retrospective review of all eligible patients who participated in GPC (n = 143) and a random sample of patients participating in TPC (n = 290) who followed up at our institution within 12 weeks of delivery. Our primary outcome was the proportion of participants using a highly effective contraceptive method within 12 weeks postpartum. Contraceptives were classified in tiers (Tier 1, long-acting reversible and permanent contraception; Tier 2, oral contraceptive pills, transdermal patch, vaginal ring, or injection; Tier 3, barrier and fertility awareness methods, withdrawal, spermicide; and no method). Tier 1 and Tier 2 methods were considered highly effective. RESULTS: The prevalence of highly effective contraceptive use by 12 weeks postpartum was 63.6% (91 of 143) and 63.1% (183 of 290) among participants in GPC and TPC, respectively (p = 0.99). We found no difference in Tier 1 versus other method use (adjusted odds ratio (aOR) 1.05, 95% CI 0.95-1.15, p = 0.34) or Tier 2 versus other method use between groups (aOR 0.98, 95% CI 0.89-1.08, p = 0.69), in a multivariable model controlling for demographic and clinical factors. CONCLUSIONS FOR PRACTICE: The prevalence of highly effective contraceptive use at 12 weeks postpartum was not different between GPC and TPC participants in this study. GPC was not associated with increased use of Tier 1 or Tier 2 contraceptive methods.

Pregnancies lost and found: a quality improvement project to increase follow-up for early pregnancy complications.

Pregnancy of unknown location (PUL) and medically managed ectopic pregnancy (EP) require longitudinal surveillance to avoid adverse outcomes; however, patients with PUL/EP in the United States (U.S.) are often unable to adhere to recommended treatment plans. This quality improvement (QI) project sought to improve PUL/EP follow-up using a three-pronged intervention: standardised recall procedures, direct patient-provider communication and electronic medical record (EMR) documentation templates and tracking. We compared patients with PUL/EP managed before and after the QI project. Our primary outcome was completion of PUL/EP clinical care. Demographics, initial diagnoses and adverse outcomes were similar between 87 pre-QI and 81 post-QI patients. Significantly more patients completed PUL/EP clinical care post-QI (80.2 vs. 65.5% p = .03). Post-QI, more providers contacted patients at standard intervals (100 vs. 57.1%, p < .0001), and EMR documentation was improved (100 vs. 69.0%, p < .001). Simple changes to PUL/EP management improved completion of clinical care and compliance with standardised recall and documentation.IMPACT STATEMENTWhat is already known on this subject? Pregnancy of unknown location (PUL) and medically managed ectopic pregnancy (EP) require longitudinal surveillance to avoid adverse outcomes; however, patients with PUL/EP in the United States (U.S.) are often unable to adhere to recommended treatment plans.What do the results of this study add? By standardising recall procedures, ensuring direct communication between patients and providers using a dedicated cell phone, and integrating case tracking and documentation into the electronic medical record (EMR), this quality improvement (QI) project improved completion of clinical follow-up for patients with PUL/EP (overall, 80.2 vs. 65.5% pre-QI, p=.03) and for the subgroup with medically managed EP not requiring surgery (76.5 vs. 36.4% pre-QI, p= .05). We also improved providers' compliance with standardised recall procedures and EMR documentation post-QI (p < .0001). There was no difference in the number of attempts to contact patients, or in the number of surveillance blood draws actually performed. Post-QI, survey responses indicated that patients were easily able to contact their provider and understood the importance of follow-up processes.What are the implications of these findings for clinical practice and/or research? Early pregnancy care providers can utilise simple strategies to improve follow-up of patients with PUL and medically managed EP, without increasing burdens to their health systems. Patients' favourable experiences with this management support its implementation.

Knowledge and Attitudes About Sterilization and Long-Acting Reversible Contraception.

OBJECTIVES: To describe understanding of the irreversible nature of permanent contraception and knowledge and attitudes about long-acting reversible contraception (LARC) among individuals seeking and not seeking permanent contraception. METHODS: We performed a cross-sectional survey among patients with Medicaid insurance attending an obstetrics and gynecology clinic in [location]. The survey consisted of 20 true/false and Likert questions assessing knowledge and perceptions about permanent contraception and LARC. Sixty-seven participants were needed to detect a small-to-medium Cohen's effect size f2 = 0.20, with 95% power and alpha = 0.05. RESULTS: Ninety potential participants were contacted and 67 were recruited. Forty-three participants desired permanent contraception and 24 did not. Approximately half of all participants were not aware that permanent contraception is irreversible. Participants who desired permanent contraception had lower LARC knowledge scores (62% correct versus 70%, p = 0.042) and more negative perceptions about LARC (54% versus 38%, p = 0.048). Fewer participants desiring permanent contraception identified LARC efficacy as equal to permanent contraception (32% versus 83%, p < 0.01), and fewer would consider using LARC (intrauterine device: 23% versus 58%, p < 0.01; implant: 16% versus 46%, p < 0.01). These differences persisted in multivariable models adjusting for age, gravidity, and parity. CONCLUSIONS FOR PRACTICE: Individuals who desire permanent contraception may not be aware of its permanence, or of equally effective alternatives. They were also found to have more negative perceptions of LARC in our sample. Additional research is needed to understand factors underlying these differences. Counseling practices should be tailored to ensure accurate knowledge about permanent contraception and LARC for all people seeking to avoid pregnancy.

Ultrasound assessment of postplacental copper intrauterine device position 6 months after placement during cesarean delivery.

OBJECTIVE: The objective was to describe the sonographic position of copper intrauterine devices (IUDs) 6 months after insertion during cesarean delivery. STUDY DESIGN: This prospective, observational study followed participants who received a copper IUD during cesarean delivery. We performed pelvic examination at 6 weeks and 6 months and sonography at 6 months to determine IUD position. Patients had additional examinations as needed to address complications. RESULTS: Sixty-nine participants provided outcomes through 6 months: 41 (59%) had correctly positioned IUDs, 21 (30%) had malpositioned intrauterine IUDs, 5 experienced expulsion (3 partial, 2 complete), and 2 had elective removal; 52 (75%) had missing strings. Missing strings at 6 weeks predicted an incorrect IUD position in 22 of 52 participants (positive predictive value 42%), and visible or palpable strings predicted a correct IUD position in 7 of 12 participants (negative predictive value 58%). CONCLUSION: Although 59% of copper IUDs placed during cesarean were correctly positioned at 6 months, nearly one third were malpositioned. IMPLICATIONS: Ultrasound may be indicated for patients receiving a copper IUD during cesarean delivery as checking IUD strings alone does not assure correct placement. Providers offering postpartum IUDs should ensure that appropriate processes for the evaluation and management of devices with missing strings or abnormal position are available to all patients regardless of insurance status.

Effect of contraceptive choice on rapid repeat pregnancy.

OBJECTIVE: To describe the prevalence of rapid repeat pregnancy (RRP), defined as repeat pregnancy within 18 months of delivery, in a large health system and to determine the impact of contraceptive method on RRP. STUDY DESIGN: Retrospective cohort. RESULTS: The prevalence of RRP among patients who delivered in August 2014 (n=804) was 27.2%. After controlling for age and sociodemographic characteristics, women experiencing RRP were less likely to have used long-acting reversible contraception (LARC) [adjusted odds ratio (aOR) 0.45, 95% confidence interval (CI) 0.24-0.85, p=.014; RRP in 19% of implant and 18% of IUD users)] and more likely to have been prescribed a progestin-only pill (aOR 5.106, 95% CI 2.157-12.083, p<.001; RRP in 53% of users) compared to women choosing all other reversible contraceptive methods. CONCLUSIONS: Postpartum LARC decreases the odds of RRP, while a prescription for progestin-only pills is not protective.

Postpartum contraceptive counseling for first-time adolescent mothers: a randomized controlled trial.

PURPOSE: Rapid repeat pregnancy is common among adolescent mothers and is associated with increased risks of adverse perinatal and maternal outcomes. Increasing contraceptive uptake among postpartum adolescents may decrease these outcomes through pregnancy prevention. This randomized controlled trial of 100 postpartum adolescent women assessed the effect of a standardized immediate postpartum contraceptive counseling intervention emphasizing healthy birth spacing and the use of long-acting reversible contraceptives (LARC). METHODS: After a baseline survey about reproductive health and pregnancy intentions, all subjects received routine postpartum contraceptive counseling. The intervention group also received the standardized counseling intervention. All participants had access to immediate postpartum contraceptive implant initiation or to intrauterine device (IUD) insertion at postpartum follow-up. Contraceptive use and repeat pregnancy were assessed quarterly for 12 months. Differences in repeat pregnancy, as well as contraceptive initiation, continuation, and satisfaction were analyzed. RESULTS: There was no difference in repeat pregnancy or contraceptive initiation, continuation or satisfaction between the study groups. However, regardless of group assignment, all subjects who desired the contraceptive implant used the method, compared to 15% of subjects who desired the IUD (p < 0.001). Three pregnancies occurred among subjects who desired the IUD versus none amongst subjects who desired the implant (p = 0.10). CONCLUSIONS: This standardized postpartum contraceptive counseling intervention did not affect teens' repeat pregnancies or contraceptive use. However, immediate postpartum availability of the contraceptive implant was associated with increased utilization of this method when compared to the IUD. Future postpartum contraceptive efforts should investigate procedures to improve teens' access to postpartum contraception. CLINICALTRIALS. GOV IDENTIFIER: NCT01814930.

A Decision Analysis Model of 1-Year Effectiveness of Intended Postplacental Compared With Intended Delayed Postpartum Intrauterine Device Insertion.

OBJECTIVE: To compare, using decision analysis methodology, the 1-year probability of pregnancy after intended postplacental intrauterine device (IUD) insertion with intended delayed insertion at an outpatient postpartum visit (delayed postpartum placement). METHODS: We developed an evidence-based decision model with the primary outcome of 1-year probability of pregnancy. We compared 1-year probability of pregnancy after intended postplacental or intended delayed postpartum IUD placement. We obtained estimates from the literature for the proportions of the following: mode of delivery, successful IUD placement, IUD type, postpartum visit attendance, IUD expulsion, IUD discontinuation, and contraceptive use, choice, and efficacy after IUD discontinuation. We performed sensitivity analyses and a Monte Carlo simulation to account for variations in proportion estimates. RESULTS: One-year probabilities of pregnancy among a theoretical cohort of 2,500,000 women intending to receive a postplacental IUD after vaginal birth and 1,250,000 women intending to receive a postplacental IUD after cesarean birth were 17.3% and 11.2%, respectively; the 1-year probability of pregnancy among a theoretical cohort of 2,500,000 women intending to receive a delayed postpartum IUD was 24.6%. For delayed postpartum IUD placement to have effectiveness equal to postplacental placement, 91.4% of women delivering vaginally and 99.7% of women delivering by cesarean would need to attend postpartum care. Once placed, the effectiveness of postplacental IUDs was lower than that of delayed postpartum IUDs: 1-year probabilities of pregnancy after IUD placement at a vaginal birth, cesarean birth, and an outpatient postpartum visit were 15.4%, 6.6%, and 3.9%, respectively. CONCLUSION: After accounting for factors that affect successful IUD placement and retention, this decision model indicates that intended postplacental IUD insertion results in a lower 1-year probability of pregnancy as compared with intended delayed postpartum IUD insertion.

Six-month expulsion of postplacental copper intrauterine devices placed after vaginal delivery.

BACKGROUND: Immediate placement of an intrauterine device after vaginal delivery is safe and convenient, but longitudinal data describing clinical outcomes have been limited. OBJECTIVE: We sought to determine the proportion of TCu380A (copper) intrauterine devices expelled, partially expelled, malpositioned, and retained, as well as contraceptive use by 6 months postpartum, and determine risk factors for expulsion and partial expulsion. STUDY DESIGN: In this prospective, observational study, women who received a postplacental TCu380A intrauterine device at vaginal delivery were enrolled postpartum. Participants returned for clinical follow-up at 6 weeks, and for a research visit with a pelvic exam and ultrasound at 6 months. We recorded intrauterine device outcomes and 6-month contraceptive use. Partial expulsion was defined as an intrauterine device protruding from the external cervical os, or a transvaginal ultrasound showing the distal end of the intrauterine device below the internal os of the cervix. Multinomial logistic regression models identified risk factors associated with expulsion and partial expulsion by 6 months. The area under the receiver operating characteristics curve was used to assess the ability of a string check to predict the correct placement of a postplacental intrauterine device. The primary outcome was the proportion of intrauterine devices expelled at 6 months. RESULTS: We enrolled 200 women. Of 162 participants with follow-up data at 6 months, 13 (8.0%; 95% confidence interval, 4.7-13.4%) experienced complete expulsion and 26 (16.0%; 95% confidence interval, 11.1-22.6%) partial expulsion. Of 25 malpositioned intrauterine devices (15.4%; 95% confidence interval, 10.2-21.9%), 14 were not at the fundus (8.6%; 95% confidence interval, 5.2-14.1%) and 11 were rotated within the uterus (6.8%; 95% confidence interval, 3.8-11.9%). Multinomial logistic regression modeling indicated that higher parity (odds ratio, 2.05; 95% confidence interval, 1.21-3.50; P = .008) was associated with expulsion. Provider specialty (obstetrics vs family medicine; odds ratio, 5.31; 95% confidence interval, 1.20-23.59; P = .03) and gestational weight gain (normal vs excess; odds ratio, 9.12; 95% confidence interval, 1.90-43.82; P = .004) were associated with partial expulsion. Long-acting reversible contraceptive method use at 6 months was 80.9% (95% confidence interval, 74.0-86.6%). At 6 weeks postpartum, 35 of 149 (23.5%; 95% confidence interval, 16.9-31.1%) participants had no intrauterine device strings visible. Sensitivity of a string check to detect an incorrectly positioned intrauterine device was 36.2%, and specificity of the string check to predict a correctly positioned intrauterine device was 84.5%. This corresponds to an area under the receiver operating characteristics curve of 0.5. CONCLUSION: This prospective assessment of postplacental TCu380A intrauterine device placement, with ultrasound to confirm device position, finds a complete intrauterine device expulsion proportion of 8.0% at 6 months. The association of increasing parity with expulsion is consistent with prior research. The clinical significance of covariates associated with partial expulsion (provider specialty and gestational weight gain) is unclear. Due to the observational study design, any associations cannot imply causality. The proportion of partially expelled and malpositioned intrauterine devices was high, and the area under the receiver operating characteristics curve of 0.5 indicates that a string check is a poor test for assessing device position. Women considering a postplacental intrauterine device should be counseled about the risk of position abnormalities, as well as the possibility of nonvisible strings, which may complicate clinical follow-up. The clinical significance of intrauterine device position abnormalities is unknown; future research should evaluate the influence of malposition and partial expulsion on contraceptive effectiveness and side effects.

A randomized pilot evaluation of individual-level abortion stigma resulting from Pennsylvania mandated abortion counseling.

OBJECTIVE: The objective was to investigate the effect of mandated abortion counseling requirements intended to dissuade women from having abortions on patients' individual-level abortion stigma. METHODS: We randomized women presenting for abortion to complete a demographic survey and the validated Individual Level Abortion Stigma (ILAS) scale either before (unexposed) or after (exposed) hearing the mandatory Pennsylvania Abortion Control Act counseling via a standardized video. A sample size of 46 (23 per group) allowed us to detect a 1-standard-deviation difference in mean ILAS score between the groups. The ILAS scale ranges from 0 to 3.5, with higher scores indicating greater stigma. RESULTS: From November 2015 to April 2016, 46 participants completed the study. All baseline characteristics were balanced except that the unexposed group had a greater proportion of low-income participants. The mean ILAS score among all participants was 1.02±0.60. ILAS scores were significantly higher among the unexposed group (median 1.25, interquartile range [IQR] 0.7-1.9) compared to the exposed group (median 0.75, IQR 0.5-1.05; p=.016). However, when controlling for participant income category, the effect of the mandated counseling on stigma scores was no longer present (p=.068). CONCLUSIONS: In this randomized trial, stigma scores were higher among women who had not heard the mandated abortion counseling when compared with stigma scores for those who had heard the script, but this effect was confounded by participants' income category. IMPLICATIONS: Despite the small sample size in this pilot study, differences in stigma scores for women exposed and unexposed to mandated counseling approached significance even after controlling for income category. Women who heard the mandated counseling had reduced stigma scores. A larger study is needed to better characterize this effect. Further research is needed to understand how state policies, counseling interactions and socioeconomic status are related to abortion stigma.

Doulas for surgical management of miscarriage and abortion: a randomized controlled trial.

BACKGROUND: Women undergoing office-based surgical management of a failed or undesired pregnancy often report fear of pain and anxiety pertaining to the procedure. Doulas are trained to specifically address women's physical and emotional needs in obstetric care, and recently have extended their practice to support women through all pregnancy outcomes. OBJECTIVE: We sought to evaluate the impact of doulas on patients' physical and emotional responses to surgical management of a first-trimester failed or undesired pregnancy under local anesthesia. STUDY DESIGN: In this nonblinded, randomized trial, women received doula support or routine care during office uterine aspiration for failed or unwanted pregnancies in the first trimester. The primary outcome was pain measured on a 100-mm visual analog scale. Secondary outcomes included satisfaction, emotional state, sense of personal empowerment, and ability to cope immediately and 1 month after the procedure, as well as medical assistants' assessment of the doula's utility. A sample size of 35 per group (N = 70) was planned to detect a 20% difference in pain score. RESULTS: From April 2014 through January 2015, 129 women were screened and 70 were randomized. The 2 study groups were similar on all baseline characteristics. The primary outcome was not different between the doula and control groups (pain score 70.7 ± 24.5 mm vs 59.7 ± 32.5 mm, P = .11, respectively), even after controlling for procedure indication (P = .20). While 97% of women who received doula support reported this helped with their experience, there was no statistically significant difference in satisfaction, emotional response, sense of empowerment, or perceived ability to cope between the 2 groups of women immediately following or 1 month after the procedure. Of all study participants, 72% reported that it was important to have someone with them during the procedure, but that the support person did not have to be a doula. CONCLUSION: Doula support during office uterine aspiration for failed or undesired pregnancies is well received and desired by women undergoing this procedure despite no significant effect on physical comfort or emotional responses related to the procedure. This may suggest an unmet psychosocial need for procedure-related support among such women.

The Women's Health Initiative trial and related studies: 10 years later: a clinician's view.

The Women's Health Initiative (WHI) assessed the long-term effects of hormone therapy (HT) in postmenopausal women. The WHI started HT treatment on women aged 50-79 years in order to ascertain these effects. The study was ended early, due to findings of increased risk of coronary heart disease, breast cancer, stroke, and thromboembolic complications in women receiving estrogen plus progestin, compared to placebo. An increased risk of thromboembolic complications was also demonstrated in the estrogen only component of the WHI. The WHI results were initially reported for all subjects, and showed little difference when data were not analyzed by age. New WHI sub-analyses stratifying results by age, and an extended follow-up of the WHI offer a more complete picture of the effects of HT, revealing that starting HT in postmenopausal women less than ten years from last menstrual period appears to have less risk. In addition, hysterectomized women treated with estrogen only in the WHI have showed less risk of adverse outcomes than women in the estrogen plus progestin group. In this paper, we review data supporting the use of HT administered to postmenopausal women, showing it to have more benefit than risk for symptom control, prevention of bone mineral loss and fracture, and improvement of the metabolic profile in women who began HT when they were less than 60 years of age and had their last menstrual period less than ten years previous. In hysterectomized women treated with estrogen only, a reduction in breast cancer risk was noted in all age groups. The WHI raised many important questions. Ten years later, some have been answered, including confirmation that HT for most newly menopausal women is safe and effective. The treatment of the aging woman, including hormone treatment after menopause, should remain one of our highest research priorities. This article is part of a Special Issue entitled 'Menopause'.

Lymph node dissection in the surgical management of atypical endometrial hyperplasia.

OBJECTIVE: The aim of this study was to evaluate the effect of lymph node dissection in patients with atypical endometrial hyperplasia. STUDY DESIGN: Patients undergoing surgical management of atypical endometrial hyperplasia during the study period were retrospectively identified. Clinical and pathologic information was analyzed. RESULTS: Eighty-eight patients comprised our cohort. Median age was 54 years (range, 37-85 years). Sixty-seven patients had lymph node dissection at the time of surgery for atypical endometrial hyperplasia, whereas 21 did not. Twenty-five of 88 (28.4%) had endometrial carcinoma on final uterine pathology. Stages were as follows: 4 IA, 15 IB, 3 IC, 2 IIB, and 1 IIIC. Surgical outcomes were not statistically significant between staged and unstaged groups. Information from lymph node dissection influenced management decisions in 7 of the 25 (28%) cancer patients. CONCLUSION: Lymph node dissection did not adversely affect surgical outcomes in patients with atypical endometrial hyperplasia. Because many of these patients have concurrent endometrial cancer, we recommend consideration of lymph node dissection in atypical endometrial hyperplasia patients undergoing definitive surgical treatment.

Fortuitous detection of endocervical adenocarcinoma in situ: a report of 2 cases.

BACKGROUND: The Pap smear and oncogenic human papillomavirus (HPV) testing are highly effective in screening for cervical cancer precursors. Cervical glandular abnormalities, however, are more difficult to detect and monitor than are squamous lesions. CASES: We present 2 cases of premenopausal women with normal Pap smears, but oncogenic HPV infection and metrorrhagia. Biopsies revealed adenocarcinoma in situ, and cold-knife conization was performed. CONCLUSION: Because glandular cancerous precursors can remain undetected by Pap screening, thorough evaluation of symptomatic patients with high-risk HPV is imperative.

Postpartum radical trachelectomy for IB1 squamous cell carcinoma of the cervix diagnosed in pregnancy.

Standard management of stage IB1 cervical cancer in pregnancy is radical hysterectomy with fetus in situ if diagnosis precedes viability, or cesarean radical hysterectomy. Postpartum abdominal radical trachelectomy was performed as an alternative, fertility-preserving surgery in a 30-year-old nulliparous woman diagnosed with stage IB1 cervical at 21 weeks' gestation.