BACKGROUND: This study was conducted to compare the safety, effectiveness and acceptability of 400 mcg sublingual misoprostol and 600 mcg oral misoprostol for treatment of incomplete abortion. STUDY DESIGN: We used an open-label randomized controlled trial conducted from July 2005 to August 2006 in a large tertiary level maternity hospital in Antananarivo, Madagascar, and a large tertiary level hospital in Chisinau, Moldova. Three hundred consenting women seeking treatment for clinically diagnosed incomplete abortion with uterine size ≤12 weeks since last menstrual period were randomized to misoprostol either 600 mcg orally or 400 mcg sublingually. The primary outcome measure was the complete resolution of clinical signs and symptoms of incomplete abortion without need for surgical intervention. Women were seen for follow-up on Day 7 and, if necessary, on Day 14 to assess abortion status. The study was powered to detect a 7% difference in efficacy with a total of 142 women required in each arm. RESULTS: Efficacy rates were 94.6% and 94.5%, for the oral and sublingual routes, respectively (RR: 1.00, 95% CI=0.95–1.06, p=.98). At 1 week follow-up, more than 80% of women had completed abortions (77.8% oral and 84.8% sublingual, p=.12). Mean pain scores were 2.95 and 3.04, respectively, for the oral and sublingual groups. Side effects included abdominal pain, bleeding, headaches and dizziness/weakness with no differences reported between the two groups. Acceptability and satisfaction were high for both routes and women indicated a preference for medical versus surgical treatment if ever needed in the future. CONCLUSION: Both treatment regimens were very effective. Four hundred micrograms of sublingual misoprostol and 600 mcg oral misoprostol appear to have similar safety and effectiveness profiles when used for the treatment of incomplete abortion. A lower 400-mcg misoprostol dose may provide an alternative treatment option as well as have potential benefits in terms of cost.
"BACKGROUND: In low-resource settings, where abortion is highly restricted and self-induced abortions are common, access to post-abortion care (PAC) services, especially treatment of incomplete terminations, is a priority. Standard post-abortion care has involved surgical intervention but can be hard to access in these areas. Misoprostol provides an alternative to surgical intervention that could increase access to abortion care. We sought to gather additional evidence regarding the efficacy of 400 mcg of sublingual misoprostol vs. standard surgical care for treatment of incomplete abortion in the environments where need for economical Non-surgical treatments may be most useful. METHODS:A total of 860 women received either sublingual misoprostol or standard surgical care for treatment of incomplete abortion in a multi-site randomized trial. Women with confirmed incomplete abortion, defined as past or present history of vaginal bleeding during pregnancy and an open cervical os, were eligible to participate. Participants returned for follow-up one week later to confirm clinical status. If abortion was incomplete at that time, women were offered an additional follow-up visit or immediate surgical evacuation. RESULTS: Both misoprostol and surgical evacuation are highly effective treatments for incomplete abortion (misoprostol: 94.4%, surgical: 100.0%). Misoprostol treatment resulted in a somewhat lower chance of success than standard surgical practice (RR = 0.90; 95% CI: 0.89-0.92). Both tolerability of side effects and women's satisfaction were similar in the two study arms. CONCLUSION: Misoprostol, much easier to provide than surgery in low-resource environments, can be used safely, successfully, and satisfactorily for treatment of incomplete abortion. Focus should shift to program implementation, including task-shifting the provision of post-abortion care to mid- and low- level providers, training and assurance of drug availability."
"OBJECTIVE: To explore 400-μg sublingual misoprostol as primary treatment in lower-level facilities with No previous experience providing post-abortion care. METHODS: Women presenting with incomplete abortion were offered a single dose of 400-μg sublingual misoprostol. Incomplete abortion was defined as uterine size consistent with fewer than 12 weeks of gestation, open cervical os, and reports of past or present history of vaginal bleeding. Women returned to the clinic 1 week after misoprostol administration for follow-up. At that time, they were discharged if the uterine evacuation was a success or were offered a second follow-up visit or surgical completion if still incomplete. RESULTS: One-hundred women received misoprostol; outcome data were unavailable for 1 woman. Complete uterine evacuation was achieved for 97 (98.0%) women. Satisfaction was high, with nearly all women indicating that they were ""satisfied"" (n=57 [57.6%]) or ""very satisfied"" (n=41 [41.4%]) with their experience. Adverse effects were considered ""tolerable"" by 72 of 97 (74.2%) women. Ninety-seven of 99 (98.0%) participants indicated that they would choose misoprostol for incomplete abortion care in the future and 95 of 97 (97.9%) stated that they would recommend it to a friend. CONCLUSION: Misoprostol is a viable option for treatment of incomplete abortion at mid-level facilities. "
OBJECTIVE: To investigate whether 600-mug oral misoprostol is an effective alternative to manual vacuum aspiration (MVA) for the treatment of incomplete abortion. METHODS: From June 16, 2004, to July 20, 2005, 230 women of reproductive age presenting with incomplete abortion were randomized in an open-label trial to either 600-mug oral misoprostol or MVA for the treatment of incomplete abortion. RESULTS: Regardless of the assigned method, more than 98% of participants experienced complete uterine evacuation following initial treatment. Efficacy, acceptability, and satisfaction ratings were similar and high for both methods. CONCLUSION: 600-mug oral misoprostol is a safe, effective, and acceptable alternative to MVA for the treatment of incomplete abortion.
"OBJECTIVE: To determine the feasibility of introducing misoprostol as first-line treatment for incomplete abortion at a secondary-level health facility. METHODS: An open-label prospective study was conducted in a secondary-level health facility in Nigeria. Eligible women diagnosed with incomplete abortion received 400-μg sublingual misoprostol as first-line treatment. Nurse-midwives took the lead in diagnosis, counseling, treatment, and assessment of final outcome. The primary outcome was the proportion of women who completed the abortion process. RESULTS: Complete evacuation was achieved in 83 of 90 (92.2%) eligible women. The most common adverse effects were abdominal pain/cramps (58 [64.4%]), heavy bleeding (21 [23.3%]), spotting (15 [16.7%]), and fever/chills (11 [12.2%]). More than 90% of women reported that the procedure was satisfactory, that pain and adverse effects were tolerable, and that bleeding was acceptable. Eighty-four (93.3%) and 86 (95.6%) women, respectively, would use the method in the future and recommend it to friends. CONCLUSION: Misoprostol is an effective, safe, and acceptable method for treating incomplete abortion. It can be successfully used as first-line treatment by nurse-midwives. Success rates over 90% are consistent with findings from previous studies in which drug administration was controlled solely by physicians."
Improving the care of women who have undergone a spontaneous or induced abortion is an important step in reducing abortion-related morbidity and mortality. Both the International Federation of Gynecology and Obstetrics (FIGO) and the World Health Organization recommend the use of manual vacuum aspiration (MVA) and misoprostol rather than sharp curettage to treat incomplete abortion. MVA was introduced into the public healthcare service in Benin in 2006 and since 2008 misoprostol has been available in 3 large maternity hospitals. The present study opted to use an oral dose of 800 mug and Not to limit to pregnancies of up to 12 weeks, but to include women with second trimester abortions. After 5 years, results show that around three-quarters of the women treated with misoprostol at 13-18 weeks of pregnancy required MVA to complete uterine evacuation and approximately one-quarter had severe bleeding, confirming that the indication of misoprostol for incomplete abortion should be limited to pregnancies of up to 12 weeks.
Preference for manual vacuum aspiration (MVA) and its use for the treatment of incomplete abortion were evaluated among 52 healthcare professionals in 7 Yaoundé hospitals in Cameroon. All but one healthcare professional preferred MVA; however, this technique was available at all times in only two hospitals. In some hospitals, MVA use was only available during the day, while in others it was Not available at all. Based on these findings, MVA kits were obtained from the International Federation of Gynecology and Obstetrics (FIGO) for training and to supply selected hospitals. The result was a dramatic increase in the use of MVA in all of the hospitals that received the kits. In one hospital, No kits were received; however, the staff had been sensitized to the problem and the equipment belonging to one of the physicians was put into service. The successful experience of this pilot project provides a rationale for expanding MVA use for incomplete abortion to the entire country.
"OBJECTIVE: To expand access to post-abortion care (PAC) services in Senegal by introducing misoprostol as a first-line treatment at the community level. METHODS: The present prospective study enrolled 481 women seeking treatment for incomplete abortion at 11 community health posts in Senegal between September 2011 and August 2012. Participants were given 400 μg of sublingual misoprostol and asked to return to the clinic 1 week later to confirm clinical status. At study completion, all women were asked to respond to a series of questions regarding their experience with this method. All care was provided by nurse midwives. RESULTS: All but three of the study women (99.4%; 474/477) had successful complete abortion after taking misoprostol. Almost all women were satisfied or very satisfied with the treatment (99.6%; 469/471), would select the method again if needed (98.9%; 465/470), and would recommend the method to a friend (99.8%; 468/469). CONCLUSION: The results provide further evidence that 400 μg of misoprostol is highly effective for first-line treatment of incomplete abortion. Furthermore, this regimen can be fully provided by nurse midwives, and can be easily and successfully introduced in community health settings where other methods of PAC may not previously have been available. "
OBJECTIVE: To compare the safety, efficacy, and acceptability of misoprostol versus manual vacuum aspiration (MVA) for treatment of incomplete abortion in Maputo, Mozambique. METHODS: A total of 270 women with clinically diagnosed incomplete abortions of up to 12 weeks of gestation were randomized to either 600 mug oral misoprostol or MVA. Women were followed-up seven days later to evaluate whether the abortion was complete. RESULTS: Success was high for both MVA and misoprostol groups (100% vs 91%, P=0.002). Women in the MVA arm reported fewer side effects but higher pain scores. Women who received misoprostol were significantly more likely to be "very satisfied" with the treatment and willing to choose the method again. CONCLUSION: Although oral misoprostol was less effective than MVA in this study, it was more acceptable to women. Misoprostol is well-suited for use in low-resource settings, and should be promoted as an option for the treatment of incomplete abortion.