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Progesterone Supplementation in Threatened Abortion (Prothreat)

Primary Purpose

Threatened Abortion, Progesterone Resistance

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Progesterone
Placebos
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Threatened Abortion

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Ayman Shehata Dawood

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Progesterone

Control group

Arm Description

received rectal progesterone suppositories 400 mg once daily

received placebo suppositories rectally once daily.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

abortion less than 20 weeks.
Abortion

Full Information

First Posted
April 20, 2019
Last Updated
July 15, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT03930212
Brief Title
Progesterone Supplementation in Threatened Abortion
Acronym
Prothreat
Official Title
Progesterone Supplementation in Threatened Abortion: Is it a Sound Practice?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Threatened Abortion, Progesterone Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progesterone
Arm Type
Experimental
Arm Description
received rectal progesterone suppositories 400 mg once daily
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
received placebo suppositories rectally once daily.
Intervention Type
Drug
Intervention Name(s)
Progesterone
Intervention Description
received rectal progesterone suppositories 400 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
received placebo suppositories rectally once daily.
Primary Outcome Measure Information:
Title
relief of pain
Description
questionnaire fulfilled by patient with yes or no questions
Time Frame
3 weeks
Title
completion of pregnancy beyond 20 weeks
Description
passing the age 20 weeks
Time Frame
12 weeks
Title
Stoppage of bleeding
Description
Cessation of bleeding
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
abortion less than 20 weeks.
Description
Abortion
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Ayman Shehata Dawood
City
Tanta
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
2 months

Learn more about this trial

Progesterone Supplementation in Threatened Abortion

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