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Progesterone Supplementation in Threatened Abortion (Prothreat)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930212
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Ayman S Dawood, MD, Tanta University

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).

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Study Type : Interventional  (Clinical Trial)
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 1, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930212


Locations
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Egypt
Ayman Shehata Dawood
Tanta, Egypt
Sponsors and Collaborators
Tanta University
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Responsible Party: Ayman S Dawood, MD, Lecturer, Tanta University
ClinicalTrials.gov Identifier: NCT03930212    
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Abortion, Threatened
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs