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This study will investigate the use of misoprostol for first-line treatment of incomplete abortion at tertiary hospitals in Myanmar.
The purpose of this study of is to compare subsequent fertility rates between hysteroscopy and aspirative curettage in the surgical treatment of incomplete spontaneous abortion
Women presenting with incomplete abortion and eligible for treatment with misoprostol were offered 400mcg sublingual misoprostol for treatment. Based on existing literature, the study hypothesises that women can successfully be treated with misoprostol alone as first line treatment.
During the recent decades the need for surgical evacuation of the uterus in early miscarriages and incomplete miscarriages has been questioned. It has been shown that an observational approach can be, in many cases, as good as an invasive one without increasing the incidence of uterine infections. it has been shown that misoprostol - prostaglandin E1 given for missed abortions is successful in emptying the uterus in 85% of cases without any need for surgical intervention. and during recent years many women prefer this approach than the surgical one . Many have tried using sonographic signs such as endometrial thickness, the presence of a gestational sac, and color doppler to differ between blood clots and a gestational residua in uterus, and to decide according to these signs wether there is a need for surgical evacuation or an expectant management could be used. but none of these methods have been proven to be completely efficient as predictors. In this study the investigators will examine whether the doppler indices in the uterine arteries can help to predict which gestational residua needs surgical evacuation of the uterus and which could be managed expectantly. The study hypothesis is that the resistance in uterine artery doppler will be lower in cases with intrauterine residua as opposed to high resistance in cases without residua.
Uganda is one of the countries with highest fertility rate in the world, 6.7 children per women. It is estimated that 56 percent of all pregnancies are unintended and the contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units in Uganda due to unsafe abortion is reported and considered high in international comparison. Studies have revealed that trained midlevel providers can deliver safe post abortion care for incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue misoprostol has been shown to be an effective tool in the treatment of incomplete abortions. This option is so far under-used in developing countries, especially outside the larger hospitals and private clinics. One significant limiting factor in providing safe post abortion care is the lack of providers. So far technical training has been mainly limited to physicians. Training of midlevel providers in misoprostol treatment of incomplete abortion will support task shifting in places where doctors are costly and scarce. By evaluating the effectiveness of mid-level providers (midwives); conducting MVA and administering misoprostol treatment of incomplete abortion the project is attempting to contribute to the reduction of maternal mortality and morbidity and safeguard high quality of post-abortion care. Women with incomplete abortion will be randomly allocated to undergo a clinical assessment and treatment (MVA or misoprostol) either by physician or midwife with safety and efficacy as main outcomes in a RCT carried out in hospital setting in Uganda. Our hypothesis is that there are no significant differences in effectiveness and safety between manual vacuum aspiration and misoprostol treatment of incomplete abortion provided by physicians and midwife. The involvement of midlevel providers in treatment of incomplete abortion has previously not been systematically evaluated in African health care setting.
Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.
This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.
This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion. Women diagnosed with incomplete abortion will be randomized to receive one of the following regimens: In Tanzania and Mozambique: 1. 600 mcg of oral misoprostol in one dose, or 2. Standard surgical treatment (MVA) In Moldova and Madagascar: 1. 600 mcg of oral misoprostol in one dose, or 2. 400 mcg of sublingual misoprostol in one dose. In Burkina Faso and Vietnam: 1. 400 mcg of sublingual misoprostol in one dose. We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.
In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Women could significantly benefit from a non-invasive treatment option for incomplete abortion. While safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. Especially in developing countries, infection, hemorrhage and uterine damage are still too common. Medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications.
The purpose of this study is to examine the effectiveness of Misoprostol (Cytotec; GD Searle and Co., Chicago, IL) for the management of non-viable first trimester pregnancies. Specifically, Misoprostol (15-S-15-methyl PGE1) will be compared to a placebo with expectant management in who have documented non-viable gestations. We will examine the following outcome variables: time to resolution, number of patients requiring dilation and curettage, change in hematocrit, cost to the institution, patient satisfaction, and reported side effects.