Vaginal Progesterone for Treatment of Threatened Miscarriage

Study Overview
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Brief Summary
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The purpose of the study is to assess the efficacy of vaginal micronized progesterone in the treatment of threatened miscarriage. All eligible pregnant women will be randomized to either receive vaginal progesterone or no treatment.Evaluation will be two weeks after intervention, then every 4 weeks up to 28 weeks gestation or termination of pregnancy.

Official Title
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Vaginal Progesterone for Treatment of Threatened Miscarriage; Randomized Clinical Trial

Conditions
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Threatened Miscarriage

Intervention / Treatment
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* Drug: Vaginal Progesteron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant with gestational age less than 24 weeks Presented by bleeding with or without pain Single viable fetus (confirmed by Ultrasound examination) Accepting to have vaginal medication Exclusion Criteria: Currently under medication for any chronic diseases (DM, thyroid, liver, renal, cardiac and autoimmune disease). Hypersensitivity to progesterone Any documented congenital fetal anomaly in the current pregnancy Women received hormonal treatment in the current pregnancy Patients conceived via ART

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (Progesterone Group)<br>Complete bed rest as an in/or out- patient, according to patient's preference for first 48-72 hours. Vaginal progesterone treatment as single daily dose of natural micronized progesterone (Prontogest ® 200 mg) at bedtime for 15 days. If needed, a pain killer as Indomethacin 50 mg/ rectally twice daily up to control of uterine colic . Complete abstaining from sexual activity or strenuous effort. Additionally, Rh-ve women with established viable fetuses and continue bleeding will be given a shot of anti-D immunoglobulin 300 ugm/IM ; after 12 weeks' gestation or if undergo surgical evacuation. | Drug: Vaginal Progesteron<br> <br> * Other names: Progesterone;|
| Placebo Comparator: Group II ( Control group)<br>Will follow the same plan of management without progesterone support. | Drug: Vaginal Progesteron<br> <br> * Other names: Progesterone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miscarriage rate up to 28 weeks of gestation |  | Completed 28th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at delivery or termination of pregnancy |  | Number of completed weeks at the time of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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progesterone, threatened abortion