Vaginal Progesterone for Treatment of Threatened Miscarriage

Omar Mamdouh Shaaban290 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

290

Conditions

Threatened Miscarriage

Interventions

Vaginal ProgesteronDRUG

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

RECRUITING

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

Time frame: Number of completed weeks at the time of delivery

Central Contacts

Omar M Shaaban, MD

CONTACT

+201223971457 omshaaban2000@yahoo.com

Hany Abdel-aleem, MD

CONTACT

+2088414927 aleemh@yahoo.com

Data from ClinicalTrials.gov

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