Clincosm LogoSign in Get a demo

VPM: Vaginal Progesterone for Treatment of Threatened Miscarriage

Sponsor
Omar Mamdouh Shaaban (Other)
Overall Status
Unknown status
CT.gov ID
NCT02690129
Collaborator
(none)
290
Enrollment
1
Location
2
Arms
24
Duration (Months)
12.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vaginal Progesteron
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
290 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Vaginal Progesterone for Treatment of Threatened Miscarriage; Randomized Clinical Trial
Study Start Date :
Feb 1, 2016
Anticipated Primary Completion Date :
Feb 1, 2017
Anticipated Study Completion Date :
Feb 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group I (Progesterone Group)

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.

Drug: Vaginal Progesteron
Other Names:
  • Progesterone

    		•
    Placebo Comparator: Group II ( Control group)

    Will follow the same plan of management without progesterone support.

    Drug: Vaginal Progesteron
    Other Names:
  • Progesterone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Miscarriage rate up to 28 weeks of gestation [Completed 28th week]

    Secondary Outcome Measures

    1. Gestational age at delivery or termination of pregnancy [Number of completed weeks at the time of delivery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Pregnant with gestational age less than 24 weeks

    2. Presented by bleeding with or without pain

    3. Single viable fetus (confirmed by Ultrasound examination)

    4. Accepting to have vaginal medication

    Exclusion Criteria:

    1. Currently under medication for any chronic diseases (DM, thyroid, liver, renal, cardiac and autoimmune disease).

    2. Hypersensitivity to progesterone

    3. Any documented congenital fetal anomaly in the current pregnancy

    4. Women received hormonal treatment in the current pregnancy

    5. Patients conceived via ART

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Assiut Egypt

    Sponsors and Collaborators

    • Omar Mamdouh Shaaban

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Omar Mamdouh Shaaban, Clinical Professor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT02690129
    Other Study ID Numbers:
    • treatment of miscarraige
    First Posted:
    Feb 24, 2016
    Last Update Posted:
    Feb 24, 2016
    Last Verified:
    Feb 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Omar Mamdouh Shaaban, Clinical Professor, Assiut University
    progesterone
    threatened abortion
    Additional relevant MeSH terms:
    Abortion, Spontaneous
    Abortion, Threatened
    Progesterone

    Study Results

    No Results Posted as of Feb 24, 2016