Prothreat: Progesterone Supplementation in Threatened Abortion

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT03930212

Collaborator

(none)

190

Enrollment

Location

Arms

Actual Duration (Months)

15.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Threatened Abortion Progesterone Resistance	Drug: Progesterone Drug: Placebos	Phase 4

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

190 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Progesterone received rectal progesterone suppositories 400 mg once daily	Drug: Progesterone received rectal progesterone suppositories 400 mg once daily
Placebo Comparator: Control group received placebo suppositories rectally once daily.	Drug: Placebos received placebo suppositories rectally once daily.

Arm

Intervention/Treatment

Experimental: Progesterone

received rectal progesterone suppositories 400 mg once daily

Drug: Progesterone

received rectal progesterone suppositories 400 mg once daily

Placebo Comparator: Control group

received placebo suppositories rectally once daily.

Drug: Placebos

received placebo suppositories rectally once daily.

Outcome Measures

Primary Outcome Measures

relief of pain [3 weeks]
questionnaire fulfilled by patient with yes or no questions
completion of pregnancy beyond 20 weeks [12 weeks]
passing the age 20 weeks
Stoppage of bleeding [3 weeks]
Cessation of bleeding

Secondary Outcome Measures

abortion less than 20 weeks. [12 weeks]
Abortion

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ayman Shehata Dawood	Tanta		Egypt

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayman S Dawood, MD, Lecturer, Tanta University

ClinicalTrials.gov Identifier:

NCT03930212

Other Study ID Numbers:

Prog133077

First Posted:

Apr 29, 2019

Last Update Posted:

Apr 30, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Abortion, Threatened

Progesterone

Study Results

No Results Posted as of Apr 30, 2019