Vaginal Misoprostol In Management Of First Trimester Missed Abortion.

Study Overview
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Brief Summary
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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

Official Title
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Home-Based Extended Low Dose Buccal Misoprostol Versus Hospital-Based Standard Vaginal Dose In Management Of First Trimester Missed Abortion.

Conditions
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Abortion, Missed

Intervention / Treatment
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* Drug: vaginal misoprostol
* Drug: buccal/sublingual misoprostol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: hospital- based standard dose of vaginal misoprostol<br> | Drug: vaginal misoprostol<br>* (800µgm.x 2 doses 3 hours).<br>|
| Other: Home-based extended low dose of buccal/sublingual misoprostol<br> | Drug: buccal/sublingual misoprostol<br>* 200 µgm.x4 hrs.x 6 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with complete abortion (success rate). |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of misoprostol doses |  | 1 week | 
| induction-abortion time |  | 1 week |