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

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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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 ]
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No

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

Ayman Shehata Dawood

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
  • 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