Olivera Vragovic

Mifepristone in Second-Trimester Medical Abortion : A Randomized Controlled Trial

OBJECTIVE: To investigate the adjunctive use of mifepristone in second-trimester induction abortions using misoprostol 1 day after feticidal digoxin. METHODS: This is a randomized, placebo-controlled, double-blind trial of mifepristone in second-trimester induction termination using misoprostol after feticidal digoxin. Women seeking abortion between 18 and 23 weeks of gestation were offered enrollment. At the time of digoxin amnioinfusion, participants received a randomly allocated, identical-appearing capsule containing either mifepristone, 200 mg, or placebo. Patients returned the following day for induction with buccal misoprostol. The primary outcome was the time interval from the first misoprostol dose to abortion. Analysis utilized survival curves with log-rank testing. RESULTS: Of 64 women, 32 received mifepristone and 32 received placebo. The groups did not differ by ethnicity, age, parity, reason for termination, or gestational age. Median procedure time was significantly shorter for those who received mifepristone, 10 hours (95% confidence interval [CI] 8–12), than those who did not, 18 hours (95% CI 15–22), P<.01, and those parous, 10 hours (95% CI 9–14), compared with nulliparous, 16 hours (95% CI 12–22, P=.02). Other findings in the mifepristone compared with placebo group included rates of placental retention, 3.1% compared with 6.3% (P=.61), length of hospitalization, 0.66 days compared with 0.8 days (P=.23), and analgesic requirements, 27.2 mg compared with 39.3 mg morphine (P=.22). Side effects during induction were similar between groups. CONCLUSION: Addition of mifepristone in second-trimester termination inductions using misoprostol significantly reduces the abortion time interval. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00382538 LEVEL OF EVIDENCE: I

Somali immigrant women's perceptions of cesarean delivery and patient-provider communication surrounding female circumcision and childbirth in the USA.

To explore perceptions of cesarean delivery and patient–provider communication surrounding female circumcision and childbirth through interviews with Somali women residing in the USA.

Abnormal anal cytology in HIV-infected women

OBJECTIVE The purpose of this study was to assess the prevalence of and risk factors for abnormal anal cytology and human papillomavirus (HPV) infections in women who are human immunodeficiency virus (HIV) positive. STUDY DESIGN We conducted an observational single center study of 100 HIV-infected women with cervical and anal specimens that were obtained for cytologic and high-risk HPV testing with Hybrid Capture 2. RESULTS Seventeen women had abnormal anal cytology; 16 women had anal HPV; 21 women had abnormal cervical cytology, and 24 women had cervical HPV. Abnormal anal cytology was associated with cervical HPV infection, abnormal cervical cytology, and anal HPV infection in univariate analysis. In multivariate analysis, abnormal anal cytology was associated with a CD4 count <200 cells/mm(3), a history of sexually transmitted disease, and concurrent cervical cytologic abnormality. CONCLUSION HIV-infected women are at high risk for abnormal cytology and HPV infections of both the anus and cervix. Risk factors for abnormal anal cytology include abnormal cervical cytology, cervical and anal HPV infections, and low CD4 count.

Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14–16 weeks: a randomized trial ☆ ☆☆ ★

BACKGROUND Cervical preparation is recommended before second-trimester abortion. We investigated the use of a pharmacologic method of preparation, mifepristone, as compared to osmotic dilators for surgical abortions at 14-16 weeks. STUDY DESIGN This was a randomized, parallel-group study with concealed allocation. Women were allocated to receive osmotic dilators or mifepristone 200 mg orally 24 h prior to abortion. The study population was 50 women seeking surgical abortion at 14-16 menstrual weeks in a hospital-based abortion service. The primary outcome was the length of time to perform the procedure; the study had 80% power to detect a difference of more than 3 min in procedure time. Secondary outcomes included cervical dilation, side effects and acceptability. RESULTS The mean abortion time for the osmotic dilator group was 8.00 min [95% confidence interval (CI) 6.75-11.47], and that for the mifepristone group was 9.87 min (95% CI 8.93-11.36). Side effects of pain were more common in the osmotic dilator group. CONCLUSION Mifepristone did not increase the time for abortion by more than the prespecified margin (3 min). Women preferred mifepristone to osmotic dilators.

Mifepristone and Misoprostol Compared With Osmotic Dilator Insertion Before Surgical Abortion at 15–18 Weeks

BACKGROUND: Cervical preparation is recommended before surgical evacuation of second-trimester pregnancies. Both mechanical (osmotic dilator) and pharmacologic (misoprostol) methods are used in the United States. Mifepristone facilitates medical abortion in the second trimester. The combination of mifepristone and misoprostol may effectively permit evacuation without the need for osmotic dilators. METHODS: A randomized controlled trial of 50 women was performed to compare pharmacologic cervical preparation with mifepristone and misoprostol with mechanical preparation with osmotic dilators. Group 1 was administered mifepristone 200 mg orally 24 hours before uterine evacuation plus misoprostol 400 mcg buccally 2 hours before the procedure. Group 2 underwent osmotic dilator insertion 24 hours before the procedure. The primary outcome was total procedure time from insertion of the speculum to removal of the speculum. RESULTS: For total procedure time, mifepristone (median 13.0 minutes) was noninferior to osmotic dilators (median 14.5 minutes, P=.99). Operative time (from intrauterine instrumentation to speculum removal) was also noninferior (mifepristone median 7.0 minutes, osmotic dilator median 8.5 minutes, P=.51). Initial dilation was less with mifepristone (41 French compared with 56 French), but procedure dilation was similar (58 French compared with 60 French). Physicians rated the ease of procedure similarly for both techniques. Women had more cramping and bleeding overnight with osmotic dilators. Women in both groups said they would prefer mifepristone if they ever needed another procedure. CONCLUSION: Use of a pharmacologic method of cervical preparation did not result in longer procedure times and was acceptable to both operators and patients.

Early medical abortion with methotrexate and misoprostol: outcomes and satisfaction among women aged 15-21 years.

STUDY OBJECTIVE To compare the outcomes of women aged 15-21 yr to those of older women in a multicenter case series of early medical abortion. DESIGN, SETTING, PARTICIPANTS We enrolled 1973 women at 34 outpatient Planned Parenthood sites in a case series for medical abortion in the first seven weeks of pregnancy. We used methotrexate (50 mg/m(2)) and misoprostol (800 mg vaginally, repeated as needed). We compared women who started the abortion prior to their 22(nd) birthday to older women. Outcomes of abortion were classified as documented or presumed complete medical abortion, and documented or presumed suction curettage. During the first half of the study, we did an exit interview assessing patient satisfaction. RESULTS A total of 330 women were under 22 yr and 1641 women over 21 yr. Younger women presented for abortion at the same gestational ages. Overall, younger women had a higher rate of complete medical abortion than did older women (89.4% vs 83%). However, the multiple regression model demonstrated a significant adverse effect of prior live birth (P = 0.006), but not patient age, on outcome. Younger women were less likely to have had prior live births. Younger women were more likely to return for follow-up (96.4% vs 92.9%); the regression model demonstrated a significant effect (P = 0.001) of prior birth on rates of follow-up. Side effects and satisfaction were similar for older and younger women. CONCLUSIONS Younger women having medical abortion with methotrexate and misoprostol have better outcomes and similar satisfaction levels as do older women.

Human Papillomavirus Co-testing Results Effectively Triage Normal Cervical Cytology in Hiv-positive Women Aged 30 Years and Older

Objective The aim of the study was to assess whether HIV-positive (HIV+) women aged 30 years and older with concurrent normal cervical cytology and undetectable cervical HPV have a low 3-year risk of developing cervical intraepithelial neoplasia grade 2 or higher (CIN 2+) in a clinical setting. Materials and Methods We conducted a retrospective chart review of HIV+ women aged 30 years and older at a single institution with normal cervical cytology and concurrent human papillomavirus (HPV) testing between November 2008 and December 2010. The participants were stratified by initial HPV testing results and followed to either the study end point (CIN 2+) or until the last cervical cytology or colposcopy before January 2015. Kaplan-Meier survival curves were used to analyze CIN 2+ diagnosis for follow-up with log-rank testing of the null hypothesis. Cox proportional hazard regression was performed to calculate crude and adjusted hazard ratios controlling for ethnicity and CD4 levels. Results We identified 325 HIV+ women with normal cytology and follow-up; 66 (20%) of these women had detectable HPV. The cumulative diagnosis of CIN 2+ at 4 years was significantly lower in the HPV-negative cohort compared with the HPV-positive cohort (1.4%, 95% CI = 0.3%–4.6% vs 14.5%, 95% CI = 5.8%–27.1%), respectively; the median duration to CIN 2+ diagnosis was longer in the HPV-negative cohort compared with the HPV-positive cohort (4.2 years vs 1.5 years, respectively, p < .02). Conclusions HIV+ women aged 30 years and older with concurrent normal cervical cytology and undetectable cervical HPV have a low 3-year risk of subsequent diagnosis of CIN 2+. The study validates the recently updated US recommendations for the use of co-testing in screening HIV+ women.

Health Care of Incarcerated Women: A Qualitative Study [18M]

INTRODUCTION: To describe the health care experiences of incarcerated women. METHODS: Twenty-one formerly incarcerated women participated in a qualitative study to discuss their health care experiences while in prison or jail. Data were analyzed by 2 researchers using a grounded theory approach, and interviews were stopped upon thematic saturation. RESULTS: Women who are incarcerated have high rates of mental health issues (90%), substance abuse (90%), and sexually transmitted infections (66%). Women are not routinely screened for these issues and find it challenging to receive adequate treatment. Many women are placed in solitary confinement in lieu of actual behavioral health treatment. Half of the women had been incarcerated while pregnant and reported feeling their safety was threatened. Other commonly reported themes included delays in obtaining care and medication, easy access to illegal drugs while incarcerated and lack of privacy during medical exams. The majority of women interviewed were unemployed (81%) and homeless (52%) or living in public housing (24%) post-incarceration. CONCLUSION: Incarcerated women suffer from a disproportionally higher rate of mental health and substance abuse issues than the general population. Most women reported negative experiences when attempting to access care while incarcerated. The results highlight the fragmentation and lack of standardization in correctional health systems and the need for increased resources and programmatic change.

Does the Use of Bedsider.org Increase Long-Acting Reversible Contraception Uptake in Patients Presenting for Induced First-Trimester Abortion? [21].

INTRODUCTION: The objective of this randomized controlled trial was to assess if contraceptive counseling aided by the web site Bedsider.org, as compared with routine counseling, improves uptake of long-acting reversible contraception (LARC) in women ages 18–29 years seeking first-trimester induced abortion. METHODS: Between September 2012 and November 2013, we randomized preoperative abortion clinic days to incorporate either contraceptive counseling with the aid of Bedsider.org or the health care providers routine counseling. All participants completed a precounseling questionnaire and a questionnaire at their surgical abortion appointment or at their medical abortion follow-up appointment. We assessed desired contraceptive method and usefulness of the contraceptive counseling received. RESULTS: We enrolled 345 women. Although baseline desire for a LARC method was high, 24.1% overall, there was a baseline difference in LARC desire before counseling among the Bedsider and routine groups (Bedsider, 16.7%; routine 28.3%; P=.01). For women who were counseled with Bedsider.org, 15.5% who did not initially desire LARC chose a LARC method after contraceptive counseling (P<.001). In the routine counseling group, 7.9% of women who initially did not desire LARC chose a LARC method after their abortion (P=.85). CONCLUSION AND IMPLICATION: This research supports the use of Bedsider.org, as an adjunct to counseling by an experienced health care provider, to promote postabortion LARC.

Early medical abortion with methotrexate: Outcome and satisfaction among women aged 15–20 years

Background: We investigated the outcomes of women under age 21 who participated in a multi-center case series of early medical abortion using methotrexate and misoprostol.Methods: We enrolled 1973 women in a case series for medical abortion in the first seven weeks of pregnancy, using a standardized protocol and consent for methotrexate (50 mg/m(2)) and misoprostol (800 mg vaginally, repeated as needed).For this study, women who presented for abortion prior to their 21(st) birthday were compared to older women. Outcomes of abortion were classified as complete medical abortion (CMA) and suction curettage (SC). Secondary outcomes included symptoms. We did an exit interview assessing patient satisfaction during the first year of the study, and have exit interview data for approximately half of the women enrolled.We assessed the relationship of age and outcomes first by bivariate analysis using SAS (SAS Institute, Inc., Cary, NC). A multiple logistic regression model was constructed using age, gestational age, and measures of parity.Results: There were 219 women who were under 21 (18 under the age of 18). Compared to older women, adolescents presented for abortion at the same gestational ages. Compared to older women, younger women were less likely to have finished college (2.8% vs. 38. 7%), and were less likely to have had previous pregnancies (45.4% vs 76.6%) and live births (20.2% vs. 51.3%)The distribution of symptoms during abortion, such as bleeding and cramping, was the same across age groups; the only symptom which was more frequently found in younger women was headache.Overall younger women had a slightly higher rate of CMA as older women (90.2% vs. 86.5%). However, the multiple regression (MR) model did not show an effect of the womans age on CMA. MR demonstrated an adverse effect of prior live birth, and advancing gestational age on rates of CMA; younger women were less likely to have had prior live births.Younger women were just as likely to report overall satisfaction (86.7% vs. 84.6%) with the abortion procedure and other questions of satisfaction, but were less likely to agree that the bleeding and cramping were acceptable. Conclusions: Younger women having medical abortion with methotrexate and misoprostol have similar outcomes and satisfaction levels as do older women. There is no reason to discourage adolescents who seek abortion from using a medical technique.