Vaginal Progesterone for Treatment of Threatened Miscarriage; Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Vaginal Progesteron
- Conditions
- Threatened Miscarriage
- Sponsor
- Omar Mamdouh Shaaban
- Enrollment
- 290
- Locations
- 1
- Primary Endpoint
- Miscarriage rate up to 28 weeks of gestation
- Last Updated
- 10 years ago
Overview
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.
Investigators
Omar Mamdouh Shaaban
Clinical Professor
Assiut University
Eligibility Criteria
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
Arms & Interventions
Group I (Progesterone Group)
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.
Intervention: Vaginal Progesteron
Group II ( Control group)
Will follow the same plan of management without progesterone support.
Intervention: Vaginal Progesteron
Outcomes
Primary Outcomes
Miscarriage rate up to 28 weeks of gestation
Time Frame: Completed 28th week
Secondary Outcomes
- Gestational age at delivery or termination of pregnancy(Number of completed weeks at the time of delivery)