Vaginal Progesterone for Treatment of Threatened Miscarriage

Threatened Miscarriage Clinical Trial

— VPM  

Official title:

Vaginal Progesterone for Treatment of Threatened Miscarriage; Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02690129
• Other study ID #: treatment of miscarraige
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2016
• Last updated: February 23, 2016
• Start date: February 2016
• Est. completion date: February 2018

Study information

• Verified date: February 2016
• Source: Assiut University
• Contact: Omar M Shaaban, MD
• Phone: +201223971457
• Email: omshaaban2000[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: February 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Abortion, Threatened
• Threatened Miscarriage

Intervention

Drug:
• Vaginal Progesteron

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Omar Mamdouh Shaaban

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Miscarriage rate up to 28 weeks of gestation		Completed 28th week	No
Secondary	Gestational age at delivery or termination of pregnancy		Number of completed weeks at the time of delivery	No