About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Progesterone Supplementation in Threatened Abortion

Clinicaltrials.gov identifier NCT03930212

Recruitment Status Completed

First Posted April 29, 2019

Last update posted April 30, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Threatened Abortion
    Progesterone Resistance
  • Intervention/Treatment: Drug: Progesterone
    Drug: Placebos
  • Phase: 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: January 2018
  • Actual Primary Completion Date: December 2018
  • Actual Study Completion Date: December 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.
Outcome Measures
  • Primary Outcome Measures: 1. relief of pain [ Time Frame: 3 weeks ]
    questionnaire fulfilled by patient with yes or no questions
  • 2. completion of pregnancy beyond 20 weeks [ Time Frame: 12 weeks ]
    passing the age 20 weeks
  • 3. Stoppage of bleeding [ Time Frame: 3 weeks ]
    Cessation of bleeding
  • Secondary Outcome Measures: 1. abortion less than 20 weeks. [ Time Frame: 12 weeks ]
    Abortion
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

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
Contacts
Locations

Egypt
Ayman Shehata Dawood
Tanta

Sponsors and Collaborators

Tanta University

More Information
  • Responsible Party: Tanta University
  • ClinicalTrials.gov Identifier: NCT03930212 History of Changes
  • Other Study ID Numbers: Prog133077
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: April 30, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Supporting Materials: Study Protocol
  • Time Frame: 2 months
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Abortion, Threatened