View clinical trials related to Incomplete Abortion.
Filter by:Background: Unintended pregnancies continue to cause a public health threat in Low and Middle Income countries yet with restrictive abortion laws. Over 40% of these unintended pregnancies end up as unsafe abortions leading to significant maternal morbidity and mortality. With ovulation occurring between 5-10 days after first trimester abortion, 47% of the women conceive shortly afterwards yet nearly 50% of the women never return for follow up. This study seeks to investigate effectiveness of early insertion of Intrauterine contraception (IUC) (within one week after medical Post abortion care (mPAC)) compared to Standard IUC insertion (between 2-4 weeks post PAC), in Uganda with the ultimate aim of increasing the uptake of IUC post 1st trimester medical management of incomplete abortion. Hypothesis: Null hypothesis: Early Insertion of IUC has higher expulsion rates and continued use than standard insertion after medical management among women with first trimester incomplete abortion at six months within a non-inferiority margin of 7.5%. Alternate hypothesis: Early Insertion of IUC has similar expulsion rates and continued use as standard insertion after medical management among women with first trimester incomplete abortion at six months within a non-inferiority margin of 7.5%. Methods: A Non-inferiority RCT of 2,076 participants will be conducted in 15 health facilities within Central Uganda. Baseline participant characteristics will be analyzed using descriptive statistics. For continuous variables, statistical tests such as Fisher's exact test, t-test, ANOVA and Wilcoxon-Mann-Whitney test will be used as appropriate. Binary logistic regression model will be used for factors associated with the dependent variable uptake of intrauterine contraception with p-value set <0.05 as level of significance. Intention to treat and per protocol analysis will be used for the RCTs. Study utility: A greater proportion of women undergoing medical post abortion care for incomplete abortion will receive their intended post abortion IUC within the first days after the PAC treatment compared with routine insertion at a scheduled follow up visit 2-4 weeks later. Though there could be higher expulsion rates in the early versus the standard IUC insertion, continued use at 6 months following abortion will be higher in the early insertion group as compared to the standard insertion group thereby reducing unplanned and unwanted pregnancy.
Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.
It is estimated that 47,000 women die every year due to consequences of unsafe abortion globally. The majority of pregnancy related deaths occur in low income countries where induced abortion is restricted, unmet need for contraception is high, and women's status is low. Uganda has a high total fertility rate of 5.4 children per woman, low contraceptive prevalence rate of 39%, and more than half of these pregnancies are unintended. Induced abortion is controversial and restricted in Uganda and legally permitted only to save a woman's life. As a result, women often resort to unsafe abortion- that's either performed by a person lacking the necessary skills or in an environment that does not conform to minimal medical standards. Of the estimated 314,304 women who undergo unsafe abortions each year in Uganda, about 41% receive treatment for complications. This equates to an annual rate of 12 per 1,000 women aged 15-49 years being hospitalized for induced abortion complications, which is considered high in international comparison. In Uganda, outside the larger hospitals and private settings, access to safe post abortion care and surgical facilities are scarce. Studies have showed that trained midwives can deliver safe, effective and acceptable post abortion care using misoprostol in the first trimester. Currently in Uganda, treatment of second trimester incomplete abortion is restricted to physicians. This study will provide evidence on whether treatment for incomplete abortion using misoprostol by mid-level providers can be extended to the early second trimester period. The investigators hypothesize that misoprostol treatment for incomplete second trimester abortion provided by midwives is equivalent to that of physicians requiring no further surgical intervention. Women with incomplete abortion will be randomly allocated to undergo a clinical assessment and treatment with misoprostol either by physician or midwife with safety and effectiveness as main outcomes in the RCT carried out in hospital and high volume health centres in Central Uganda.
This study will investigate the use of misoprostol for first-line treatment of incomplete abortion at tertiary hospitals in Myanmar.
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.
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.