"Background: Pain is often cited as one of the worst features of medical abortion. Further, inadequate pain management may motivate some women to seek unnecessary clinical care. There is a need to identify effective methods for pain control in this setting. Methods/Design: We propose a randomized, placebo-controlled trial. 576 participants (288 nulliparous; 288 parous) from study sites in Nepal, South Africa and Vietnam will be randomly allocated to one of three treatments: (1) ibuprofen 400 mg PO and metoclopramide 10 mg PO; (2) tramadol 50 mg PO and a placebo; or (3) two placebo pills, to be taken immediately before misoprostol and repeated once four hours later. All women will be provided with supplementary analgesia for use as needed during the medical abortion. We hypothesize that women receiving prophylactic analgesia will report lower maximal pain scores in the first 8 h following misoprostol administration compared to women receiving placebos for medical abortion through 63 days’ gestation. Our primary objective is to determine whether prophylactic administration of ibuprofen and metoclopramide or tramadol provides superior pain relief compared to analgesia administration after pain begins, measured during the first eight hours after misoprostol administration. Secondary objectives include identifying covariates associated with higher reported pain scores; determining any impact of the study medicines on medical abortion success; and, qualitatively exploring women’s physical experiences of medical abortion, especially related to pain, and how can they be improved. Data sources include medical records, participant symptom diaries and interview data obtained on the day of enrollment, during the medical abortion, and at follow-up. Participants will be contacted via telephone on day 3 and return for follow-up will occur approximately 14 days after mifepristone, concluding study participation. A subset of 42 women will also be invited to undergo in-depth qualitative interviews following study completion. Discussion: Although pain is one of the most common side effects encountered with medical abortion, little is known about optimal pain management for this process. This multi-arm trial design offers an efficient approach to evaluating two prophylactic pain management regimens compared to use of pain medication as needed."
"OBJECTIVE: Analysis of factors influencing surgical intervention rate after home medical termination of pregnancy (TOP) by women in countries without access to safe services using the telemedical service 'Women on Web'. DESIGN: Cohort study. SETTING: Women with an unwanted pregnancy less than nine weeks pregnant who used the telemedicine service of Women on Web between February 2007 and September 2008 and provided follow-up information. SAMPLE: Women who used medical TOP with a known follow up. METHODS: Information from the online consultation, follow-up form and emails was used to analyze the outcome of the TOP. MAIN OUTCOME MEASURES: Ongoing pregnancy, reason for surgical intervention, perceived complications and satisfaction. RESULTS: Of the 2 323 women who did the medical TOP and had No ongoing pregnancy, 289 (12.4%) received a surgical intervention. High rates were found in Eastern Europe (14.8%), Latin America (14.4%) and Asia/Oceania (11.0%) and low rates in Western Europe (5.8%), the Middle East (4.7%) and Africa (6.1%; p=0.000). More interventions occurred with longer gestational age (p=0.000). Women without a surgical intervention more frequently reported satisfaction with the treatment (p=0.000). CONCLUSIONS: The large regional differences in the rates of reported surgical interventions after medical TOP provided by telemedicine cannot be explained by demographic factors or differences in gestational length. It is likely that these differences reflect different clinical practice and local guidelines on (incomplete) abortion rather than complications that genuinely needed surgical intervention. Surgical interventions significantly influenced women's' views on the acceptability of the TOP. "
OBJECTIVES: To collect information about how private physicians in South Africa provide medication abortion services to their patients. METHODS: In April 2003 we asked physicians in private practice in South Africa who had purchased mifepristone (Mifegyne) from the South African distributor about the medication abortion regimen they offered, satisfaction with the method, and how services have been incorporated into their practices. RESULTS: Forty-four providers participated in the survey. They report using a range of doses and regimens. Most respondents offer mifepristone-misoprostol to their patients, although a significant minority also offer misoprostol-alone for pregnancy termination. While the majority of medication abortion providers also offer surgical abortions, a significant number of Non-surgical providers were only offering medication abortion. CONCLUSION: South African medication abortion providers find the method acceptable, indicate that their staff are largely supportive of offering it to their patients, and report that clients like the method. Those surveyed believe that most of their patients are eligible for the regimen, although uptake has been limited.
BACKGROUND AND METHODOLOGY: South Africa's Choice on Termination of Pregnancy Act of 1996 provides for safe termination of pregnancy (TOP) in designated facilities in the public and private health sectors. In 2001, mifepristone-misoprostol medical abortion was approved for TOP up to 56 days, but this method is Not yet available in the public sector. Information on the operational requirements for integrating mifepristone-misoprostol medical abortion into South Africa's public sector safe abortion services is required to guide policy decisions. This study trained health workers to provide medical abortion to 290 women attending three TOP sites. Prospective data were collected to ascertain women's experience of the method, pregnancy outcome, women's and provider's acceptability of the method, and the operational requirements for providing medical abortion. RESULTS: Twenty-nine (10%) women were lost to follow-up; 261 (90%) women had a confirmed abortion outcome, of whom 93% had a complete abortion. Given the option, the vast majority of women opted to use misoprostol at home. No serious side effects were reported; pain (66%), and heavy bleeding (67%) were the most common side effects. Most (96%) women were very satisfied with the experience. Health providers were satisfied with providing medical abortion and recommended its introduction to complement existing surgical TOP services. DISCUSSION AND CONCLUSION: This study demonstrates that integration of medical abortion into public sector services is feasible. The results of this study will guide policy decisions about integrating medical abortion into South Africa's public sector safe abortion services, within the context of the existing enabling legislative framework.
OBJECTIVE: To examine the acceptability and feasibility of medical abortion in Nigeria. METHODS: In total, 250 women who were eligible for legal pregnancy termination with a gestational age of up to 63 days since last menstrual period were enrolled in Benin City and Zaria between May 2005 and October 2006. Participants received 200 mg of oral mifepristone in the clinic and then took 400 μg of oral misoprostol 2 days later—choosing to either return to the clinic or take it at home. Women returned 2 weeks later for an assessment of abortion status. RESULTS: The vast majority (96.3%) of women had successful complete abortions. Ultrasound was used to determine outcome in less than one-third (28.9%) of participants. Most women (83.2%) took the misoprostol at home. Almost all (96.2%) participants were satisfied or very satisfied with the abortion method. CONCLUSION: The introduction of medical abortion with mifepristone and misoprostol could greatly expand current method options and improve the quality of reproductive health care in Nigeria and other settings in which access to legal abortion services is limited.
|OBJECTIVE: To test the effectiveness and acceptability of an outpatient medical abortion protocol with 200 mg mifepristone and 400 mcg sublingual misoprostol at 64-70 days' last menstrual period (LMP) and compare it to the already known efficacy of the 57-63 days' LMP gestational age range. STUDY DESIGN: We conducted a prospective, comparative open-label trial in six hospitals and clinics in Ukraine, Georgia, India and Tunisia. We enrolled 714 reproductive age women with pregnancies 57 to 70 days who presented requesting abortion. Medical abortions were managed with the current service delivery protocol (200 mg oral mifepristone followed in 24-48 h by 400 mcg sublingual misoprostol). Data on safety, efficacy and acceptability were collected. The main outcome measure was complete abortion without surgical intervention at any point.
RESULTS:A total of 703 cases were analyzable for efficacy. Success rates did Not differ significantly in the two groups [57-63-day group: 94·8%; 64-70-day group: 91.9%; Relative Risk (RR): 0.79 (0.61-1.04)]. Ongoing pregnancy rates also did Not differ significantly (57-63 days: 1.8%; 64-70 days: 2.2%; RR: 1.10 (0.65-1.87)].
CONCLUSION:A medical abortion regimen of 200 mg mifepristone followed in 24-48 h by 400 mcg sublingual misoprostol is effective through 70 days' gestation and may be offered within existing outpatient abortion services. IMPLICATIONS:A regimen of 200 mg mifepristone followed in 24-48 h by 400 mcg sublingual misoprostol is effective up to 70 days' LMP. The findings have important implications for expanding access to outpatient medical abortion services in settings where the cost of misoprostol is of concern or a two-pill misoprostol regimen is the standard of care.