Progesterone Supplementation in Threatened Abortion

NCT ID: NCT03930212

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Threatened Abortion Progesterone Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Progesterone

received rectal progesterone suppositories 400 mg once daily

Group Type EXPERIMENTAL

Progesterone

Intervention Type DRUG

received rectal progesterone suppositories 400 mg once daily

Control group

received placebo suppositories rectally once daily.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

received placebo suppositories rectally once daily.

Interventions

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Progesterone

received rectal progesterone suppositories 400 mg once daily

Intervention Type DRUG

Placebos

received placebo suppositories rectally once daily.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Ayman S Dawood, MD

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ayman Shehata Dawood

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Prog133077

Identifier Type: -

Identifier Source: org_study_id

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