Progesterone Supplementation in Threatened Abortion

Progesterone Resistance Clinical Trial

— Prothreat  

Official title:

Progesterone Supplementation in Threatened Abortion: Is it a Sound Practice?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930212
• Other study ID #: Prog133077
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To decide whether progesterone supplementation in threatened abortion is a sound practice.

Description:

This study was conducted at Obstetrics and Gynecology Department, Tanta University in the period from January 2018 to December 2018. Patients: Eligible patients (n=190) were randomly allocated into 2 groups; study group who will receive progesterone supplementation (Prog.group) and control group who will receive no treatment (place.group).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• threatened abortion diagnosed by history and ultrasound examination
• singleton
• viable fetus
• gestational age < 20 weeks
• closed normal length cervix.

Exclusion Criteria:

• short cervix <2 cm Multiple pregnancy
• dead fetus
• open cervix = 2cm
• history of cervical surgery
• refusal to participate.

Related Conditions & MeSH terms

• Abortion, Threatened
• Progesterone Resistance
• Threatened Abortion

Intervention

Drug:
• Progesterone
received rectal progesterone suppositories 400 mg once daily
• Placebos
received placebo suppositories rectally once daily.

Locations

Country	Name	City	State
Egypt	Ayman Shehata Dawood	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relief of pain	questionnaire fulfilled by patient with yes or no questions	3 weeks
Primary	completion of pregnancy beyond 20 weeks	passing the age 20 weeks	12 weeks
Primary	Stoppage of bleeding	Cessation of bleeding	3 weeks
Secondary	abortion less than 20 weeks.	Abortion	12 weeks