Vaginal Progesterone for Treatment of Threatened Miscarriage

Not Applicable

• Conditions: Threatened Miscarriage
• Interventions: Drug: Vaginal Progesteron

• Registration Number: NCT02690129
• Lead Sponsor: Omar Mamdouh Shaaban

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-02
• Study Start: 2016-02
• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-02-23
• Last Update Submitted: 2016-02-23
• Study First Posted: 2016-02-24
• Last Update Posted: 2016-02-24
• Primary Completion: 2017-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 290

Inclusion Criteria

1. Pregnant with gestational age less than 24 weeks
2. Presented by bleeding with or without pain
3. Single viable fetus (confirmed by Ultrasound examination)
4. Accepting to have vaginal medication

Exclusion Criteria

1. Currently under medication for any chronic diseases (DM, thyroid, liver, renal, cardiac and autoimmune disease).
2. Hypersensitivity to progesterone
3. Any documented congenital fetal anomaly in the current pregnancy
4. Women received hormonal treatment in the current pregnancy
5. Patients conceived via ART

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (Progesterone Group)	Vaginal Progesteron	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.
Group II ( Control group)	Vaginal Progesteron	Will follow the same plan of management without progesterone support.

Primary Outcome Measures

Name	Time	Method
Miscarriage rate up to 28 weeks of gestation	Completed 28th week

Secondary Outcome Measures

Name	Time	Method
Gestational age at delivery or termination of pregnancy	Number of completed weeks at the time of delivery

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt