Standardizing abortion research outcomes (STAR): Results from an international consensus development study.

OBJECTIVE: To develop a minimum data set, known as a core outcome set, for future abortion randomized controlled trials. STUDY DESIGN: We extracted outcomes from quantitative and qualitative systematic reviews of abortion studies to assess using a modified Delphi method. Via email, we invited researchers, clinicians, patients, and healthcare organization representatives with expertise in abortion to rate the importance of the outcomes on a 9-point Likert scale. After 2 rounds, we used descriptive analyses to determine which outcomes met the predefined consensus criteria. We finalized the core outcome set during a series of consensus development meetings. RESULTS: We entered 42 outcomes, organized in 15 domains, into the Delphi survey. Two-hundred eighteen of 251 invitees (87%) provided responses (203 complete responses) for round 1 and 118 of 218 (42%) completed round2. Sixteen experts participated in the development meetings. The final outcome set includes 15 outcomes: 10 outcomes apply to all abortion trials (successful abortion, ongoing pregnancy, death, hemorrhage, uterine infection, hospitalization, surgical intervention, pain, gastrointestinal symptoms, and patients' experience of abortion); 2 outcomes apply to only surgical abortion trials (uterine perforation and cervical injury), one applies only to medical abortion trials (uterine rupture); and 2 apply to trials evaluating abortions with anesthesia (over-sedation/respiratory depression and local anesthetic systemic toxicity). CONCLUSION: Using robust consensus science methods we have developed a core outcome set for future abortion research. IMPLICATIONS: Standardized outcomes in abortion research could decrease heterogeneity among trials and improve the quality of systematic reviews and clinical guidelines. Researchers should select, collect, and report these core outcomes in future abortion trials. Journal editors should advocate for core outcome set reporting.

'I felt the world crash down on me': Women's experiences being denied legal abortion in Colombia.

BACKGROUND: In 2006, Colombia's constitutional court overturned a complete ban on abortion, liberalizing the procedure. Despite a relatively liberal new law, women still struggle to access safe and legal abortion services. We aimed to understand why women are denied services in Colombia, and what factors determine if and how they ultimately terminate pregnancies. METHODS: We recruited women denied abortion at a private facility in Bogota. Twenty-one participants completed an initial interview and eight completed a second longer interview. Two researchers documented themes and developed and applied a codebook to transcripts using ATLAS.ti. RESULTS: Participants faced barriers, such as lack of knowledge of service availability and delayed pregnancy recognition, leading to denial. Five out of eight participants ultimately received abortions in public hospitals, due to support from partners and a robust referral system; nevertheless, they received poor care. Those who continued pregnancies endured stigmatizing events and inaccurate medical counselling at referral facilities. Several women contemplated illegal abortion though were afraid to attempt it. CONCLUSION: We propose the following recommendations: 1) increase awareness about availability and legality of abortion services to prevent delay and consequent denial; 2) provide counseling and referral upon denial; and 3) train providers in interpersonal quality abortion care.

Delays and barriers to care in Colombia among women obtaining legal first- and second-trimester abortion.

OBJECTIVE: To evaluate delays before first- or second-trimester legal abortion and barriers to care in Colombia. METHODS: A secondary analysis was undertaken of data from a prospective cohort study of women undergoing first-trimester (<12 weeks) and second-trimester (12-15 weeks) abortion between February and July 2012. Participants (aged ≥18 years with access to a telephone) reported key dates in their abortion process and barriers to care. Univariate and multivariate analyses were performed. RESULTS: Overall, 100 women in the first trimester and 200 in the second trimester were included. Second-trimester clients experienced longer delays in each step of the abortion process than did first-trimester clients (P<0.001 for all three intervals examined), with the largest delay being time to suspicion of pregnancy (37 days vs 17 days). Difficulty accessing care was associated with the second trimester (odds ratio 5.1, 95% CI 2.9-9.1) and low socioeconomic status (odds ratio 2.3, 95% CI 1.2-4.3). Financial barriers were the most common (30 [30.0%] first-trimester clients; 86 [43.0%] second-trimester clients). CONCLUSION: Despite partial decriminalization of abortion in 2006, Colombian women still face barriers to legal services that probably contribute to late presentation. Interventions promoting early pregnancy recognition and information about how to access legal abortion could reduce the need for second-trimester services.

Denial of abortion in legal settings.

BACKGROUND: Factors such as poverty, stigma, lack of knowledge about the legal status of abortion, and geographical distance from a provider may prevent women from accessing safe abortion services, even where abortion is legal. Data on the consequences of abortion denial outside of the US, however, are scarce. METHODS: In this article we present data from studies among women seeking legal abortion services in four countries (Colombia, Nepal, South Africa and Tunisia) to assess sociodemographic characteristics of legal abortion seekers, as well as the frequency and reasons that women are denied abortion care. RESULTS: The proportion of women denied abortion services and the reasons for which they were denied varied widely by country. In Colombia, 2% of women surveyed did not receive the abortions they were seeking; in South Africa, 45% of women did not receive abortions on the day they were seeking abortion services. In both Tunisia and Nepal, 26% of women were denied their wanted abortions. CONCLUSIONS: The denial of legal abortion services may have serious consequences for women's health and wellbeing. Additional evidence on the risk factors for presenting later in pregnancy, predictors of seeking unsafe illegal abortion, and the health consequences of illegal abortion and childbirth after an unwanted pregnancy is needed. Such data would assist the development of programmes and policies aimed at increasing access to and utilisation of safe abortion services where abortion is legal, and harm reduction models for women who are unable to access legal abortion services.

Acceptability and clinical outcomes of first- and second-trimester surgical abortion by suction aspiration in Colombia.

OBJECTIVE(S): Since partial decriminalization of abortion in Colombia, Oriéntame has provided legal abortion services through 15 weeks gestation in an outpatient primary care setting. We sought to document the safety and acceptability of the second trimester compared to the first-trimester surgical abortion in this setting. STUDY DESIGN: This was a prospective cohort study using a consecutive sample of 100 women undergoing surgical first-trimester abortion (11 weeks 6 days gestational age or less) and 200 women undergoing second-trimester abortion (12 weeks 0 days-15 weeks 0 days) over a 5-month period in 2012. After obtaining informed consent, a trained interviewer collected demographic and clinical information from direct observation and the patient's clinical chart. The interviewer asked questions after the procedure regarding satisfaction with the procedure, physical pain and emotional discomfort. Fifteen days later, the interviewer assessed satisfaction with the procedure and any delayed complications. RESULTS: There were no major complications and seven minor complications. Average measured blood loss was 37.87 mL in the first trimester and 109 mL in the second trimester (p<.001). Following the procedure, more second-trimester patients reported being very satisfied (81% vs. 94%, p=.006). Satisfaction was similar between groups at follow-up. There were no differences in reported emotional discomfort after the procedure or at follow-up, with the majority reporting no emotional discomfort. The majority of women (99%) stated that they would recommend the clinic to a friend or family member. CONCLUSIONS: Second-trimester surgical abortion in an outpatient primary care setting in Colombia can be provided safely, and satisfaction with these services is high. IMPLICATIONS: This is one of the first studies from Latin America, a region with a high proportion of maternal mortality due to unsafe abortion, which documents the safety and acceptability of surgical abortion in an outpatient primary care setting. Findings could support increased access to safe abortion services, particularly in the second trimester.

Updated WHO guidance on safe abortion: health and human rights.

Since its first publication in 2003, the World Health Organization's "Safe abortion: technical and policy guidance for health systems" has had an influence on abortion policy, law, and practice worldwide. To reflect significant developments in the clinical, service delivery, and human rights aspects of abortion care, the Guidance was updated in 2012. This article reviews select recommendations of the updated Guidance, highlighting 3 key themes that run throughout its chapters: evidence-based practice and assessment, human rights standards, and a pragmatic orientation to safe and accessible abortion care. These themes not only connect the chapters into a coherent whole. They reflect the research and advocacy efforts of a growing field in women's health and human rights.

A randomized controlled safety trial of the diaphragm and cellulose sulfate microbicide gel in sexually active women in Zimbabwe.

BACKGROUND: Cellulose sulfate (CS) is an antimicrobial and contraceptive agent. We assessed its safety when used alone or with the diaphragm in Harare, Zimbabwe. STUDY DESIGN: This was a randomized controlled safety trial with three arms: diaphragm with 6% CS gel vs. diaphragm with KY gel vs. CS gel alone. Participants were instructed to use their study products before every sex act for a period of 6 months. Safety end points were assessed monthly by questionnaires and urinanalysis and bimonthly by clinical examinations, colposcopy, wet mounts and gram stains. RESULTS: One hundred nineteen monogamous women were enrolled (28% HIV+) and 105 (88%) completed the study. No urinary tract infections were diagnosed during the study; 81.4% women had symptoms and/or signs of genital irritation considered at least possibly related to the gel or device, and 41.5% had changes in vaginal flora. There were no statistically significant differences between treatment groups in safety end points. All six women with deep epithelial disruption were diaphragm users, and all such findings were on the external genitalia. Of those, 4 had herpetic ulcers which were unrelated to products use. CONCLUSIONS: Cellulose sulfate appeared safe when used for 6 months alone or with a diaphragm.

Postpartum contraception: the New Mexico Pregnancy Risk Assessment Monitoring System.

OBJECTIVE: To examine factors associated with postpartum contraception, including the relationship between ethnicity and postpartum contraceptive use. METHODS: We used data from the New Mexico Pregnancy Risk Assessment Monitoring System, which monitors selected maternal events occurring before, during and after pregnancy. RESULTS: Our findings in 4096 women revealed that women who are aged >or=35 years, unmarried and lacking a postpartum visit have increased risk of no postpartum contraception. The odds of postpartum contraception were over three times greater in women with a postpartum visit [adjusted odds ratio (OR)=3.06, 95% confidence interval (CI): 2.17-4.31) and over 50% greater in married women (adjusted OR=1.57, 95% CI: 1.16-2.11). Hispanic women were more likely than were Native Americans to use postpartum contraception (OR=1.25, 95% CI: 0.95-1.64). CONCLUSION: Focused contraception counseling, especially in the postpartum setting, is important to help ensure the well-being of women and children.