Misoprostol for Management of Women With an Incomplete Miscarriage

Study Overview
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Brief Summary
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Miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks gestation, that is, before fetal viability. The clinical signs of miscarriage are usually vaginal bleeding associated with abdominal pain and cramping. The miscarriage is named 'complete' or 'incomplete' according to whether or not tissues are retained in the uterus. If a woman has minimal bleeding but her cervix is closed, this is known as a 'threatened miscarriage. However; if the pregnancy is still inside the uterus but the cervix is open, this is described as an 'inevitable miscarriage', which it will not usually be possible to save the fetus.

Detailed Description
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the aim of the study is to evaluate 2 doses with misoprostol in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment

Official Title
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Comparative Study Between Two Doses of Misoprostol in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment: A Randomized Clinical Trial

Conditions
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Miscarriage

Intervention / Treatment
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* Drug: misoprostol 800 µg
* Drug: misoprostol 400 µg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with confirmed incomplete induced miscarriage, less than 12 weeks' gestation. No known allergy to misoprostol. Women who will be hemodynamically stable. Good access to emergency facilities Exclusion Criteria: Women with signs of severe infection ( fever > 38°) Women with severe vaginal bleeding Women are known to have allergies to prostaglandins Severe abdominal pain requiring immediate intervention

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: a double-blind placebo-controlled randomized trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: misoprostol 800 µg<br>received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually | Drug: misoprostol 800 µg<br>* received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually<br>|
| Active Comparator: misoprostol 400 µg<br>received misoprostol 400 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually | Drug: misoprostol 400 µg<br>* received misoprostol 400 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually<br>* Other names: Active Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with complete miscarriage at 1 week | The number of patients with complete miscarriage at 1 week | 7 days |