Home-Based Extended Low Dose Buccal Misoprostol Versus Hospital-Based Standard Vaginal Dose In Management Of First Trimester Missed Abortion.
| Registry | NCT03148314 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 140 (Actual) |
| Sponsor | Assiut University (Other) |
| Conditions | Abortion, Missed |
| Interventions | vaginal misoprostol, buccal/sublingual misoprostol (Drug) |
| Dates | start 2017-07-01, primary completion 2018-06-01, completion 2018-06-01, first posted 2017-05-11, last updated 2024-04-24 |
| Locations | 1 site in Egypt |
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All trials for Abortion, Missed All trials of vaginal misoprostol All trials of buccal/sublingual misoprostol
The world health organization defined abortion or miscarriage as : the expulsion or extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other wise product of gestation of any weight irrespective of gestational age and weather or not there is evidence of life and weather or not the abortion was spontaneous or induced Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in miscarriage. A large majority of those are lost before the menstrual period is missed. More than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion, incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion
| Arm | Type | Interventions | Description |
|---|---|---|---|
| hospital- based vaginal misoprostol | Active comparator | Drug: vaginal misoprostol | hospital- based vaginal misoprostol |
| extended low dose oral misoprostol | Active comparator | Drug: buccal/sublingual misoprostol | extended low dose oral misoprostol |
Sex: Female, ages: 20 Years to 40 Years
Inclusion Criteria: * single dead fetus up-to 12 weeks. * no low lying placenta * no scarred uterus * no or mild bleeding * no evidence of infection * accepting to participate in the study. Exclusion Criteria: * Advanced hepatic diseases . * Suspected molar pregnancy * Ectopic pregnancy or pregnancy of unknown location * Haemodynamically unstable with significant anaemia ie Hb<10 * Uncontrolled severe asthma * Chronic adrenal failure * Known or suspected heart disease * Glaucoma * Haemoglobinopathies * Haemorrhagic disorders and anti-coagulation therapy (aspirin accepted) * Adrenal suppression and long term glucocorticoid therapy (may require corticosteroid) * Patient living in remote areas with difficulty in accessing hospital
| Facility | City | Country | Status |
|---|---|---|---|
| Women Health Hospital - Assiut university | Asyut | Egypt |