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Vaginal Progesterone for Treatment of Threatened Miscarriage (VPM)

Primary Purpose

Threatened Miscarriage

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Vaginal Progesteron

About this trial

This is an interventional treatment trial for Threatened Miscarriage focused on measuring progesterone, threatened abortion

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Pregnant with gestational age less than 24 weeks
Presented by bleeding with or without pain
Single viable fetus (confirmed by Ultrasound examination)
Accepting to have vaginal medication

Exclusion Criteria:

Currently under medication for any chronic diseases (DM, thyroid, liver, renal, cardiac and autoimmune disease).
Hypersensitivity to progesterone
Any documented congenital fetal anomaly in the current pregnancy
Women received hormonal treatment in the current pregnancy
Patients conceived via ART

Sites / Locations

Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group I (Progesterone Group)

Group II ( Control group)

Arm Description

Complete bed rest as an in/or out- patient, according to patient's preference for first 48-72 hours. Vaginal progesterone treatment as single daily dose of natural micronized progesterone (Prontogest ® 200 mg) at bedtime for 15 days. If needed, a pain killer as Indomethacin 50 mg/ rectally twice daily up to control of uterine colic . Complete abstaining from sexual activity or strenuous effort. Additionally, Rh-ve women with established viable fetuses and continue bleeding will be given a shot of anti-D immunoglobulin 300 ugm/IM ; after 12 weeks' gestation or if undergo surgical evacuation.

Will follow the same plan of management without progesterone support.

Outcomes

Primary Outcome Measures

Miscarriage rate up to 28 weeks of gestation

Secondary Outcome Measures

Gestational age at delivery or termination of pregnancy

Full Information

NCT ID

NCT02690129

First Posted

February 19, 2016

Last Updated

February 23, 2016

Sponsor

Omar Mamdouh Shaaban

1. Study Identification

Unique Protocol Identification Number

NCT02690129

Brief Title

Vaginal Progesterone for Treatment of Threatened Miscarriage

Acronym

VPM

Official Title

Vaginal Progesterone for Treatment of Threatened Miscarriage; Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2016 (undefined)

Primary Completion Date

February 2017 (Anticipated)

Study Completion Date

February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Omar Mamdouh Shaaban

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study is to assess the efficacy of vaginal micronized progesterone in the treatment of threatened miscarriage. All eligible pregnant women will be randomized to either receive vaginal progesterone or no treatment.Evaluation will be two weeks after intervention, then every 4 weeks up to 28 weeks gestation or termination of pregnancy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Threatened Miscarriage

Keywords

progesterone, threatened abortion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group I (Progesterone Group)

Arm Type

Active Comparator

Arm Description

Arm Title

Group II ( Control group)

Arm Type

Placebo Comparator

Arm Description

Will follow the same plan of management without progesterone support.

Intervention Type

Drug

Intervention Name(s)

Vaginal Progesteron

Other Intervention Name(s)

Progesterone

Primary Outcome Measure Information:

Title

Miscarriage rate up to 28 weeks of gestation

Time Frame

Completed 28th week

Secondary Outcome Measure Information:

Title

Gestational age at delivery or termination of pregnancy

Time Frame

Number of completed weeks at the time of delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pregnant with gestational age less than 24 weeks Presented by bleeding with or without pain Single viable fetus (confirmed by Ultrasound examination) Accepting to have vaginal medication Exclusion Criteria: Currently under medication for any chronic diseases (DM, thyroid, liver, renal, cardiac and autoimmune disease). Hypersensitivity to progesterone Any documented congenital fetal anomaly in the current pregnancy Women received hormonal treatment in the current pregnancy Patients conceived via ART

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Omar M Shaaban, MD

Phone

+201223971457

omshaaban2000@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hany Abdel-aleem, MD

Phone

+2088414927

aleemh@yahoo.com

Facility Information:

Facility Name

Faculty of Medicine

City

Assiut

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hany Abdel-Aleem, MD

First Name & Middle Initial & Last Name & Degree

Omar M Shaaban, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Vaginal Progesterone for Treatment of Threatened Miscarriage

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