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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03930212
Other study ID # Prog133077
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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