Comparing IM vs. Vaginal Progesterone for Pre-term Birth

April 28, 2021 updated by: University of Oklahoma

Comparing Intramuscular Versus Vaginal Progesterone for Prevention of Preterm Birth.

This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes.

Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is intended as a randomized controlled trial. Women with singleton pregnancies between 16 and 20 weeks 6 day will be randomized to one of two treatment groups.

Those randomized to weekly intramuscular progesterone will receive 250 mg of 17 alpha hydroxyprogesterone caproate every week in the clinic between randomization and delivery for those delivery preterm or 36 weeks 6 days.

While those randomized to vaginal progesterone will receive 100 mg vaginal progesterone daily at home. Vaginal progesterone to last between clinic visits will be provided to subject. Those women in the vaginal progesterone group will also be informed on how to obtain additional medication in case of missed clinic appointment. Treatment will be continued until 36 weeks 6 days or as dictated by date of preterm delivery.

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton pregnancies
  • History of spontaneous preterm brith (between 20 weeks and 36 weeks 6 days)
  • Gestational age between 16 weeks 0 days and 20 weeks 6 days.
  • Signed consent to participate in the trial

Exclusion Criteria:

  • Multiple Gestation
  • Prior elective fetal reduction or planned termination
  • Known spontaneous reduction to singleton
  • Major fetal anomaly or known fetal chromosomal abnormalities
  • Progesteone used this pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intramuscular Progesterone
Drug: Intramuscular Progesterone
Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P
Other Names:
  • 17 alpha hydroxyprogesterone caproate
Experimental: Vaginal Progesterone
Drug: Vaginal Progesterone
Vaginal Progesterone: 100 mg vaginal suppository daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm Birth
Time Frame: From 16-20 weeks gestation through preterm delivery
Delivery before 37 weeks gestation.
From 16-20 weeks gestation through preterm delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm Birth
Time Frame: From 16-20 weeks gestation through preterm delivery
Delivery below 34 weeks gestation
From 16-20 weeks gestation through preterm delivery
Gestational Age at Delivery
Time Frame: From 16-20 weeks gestation through preterm delivery
Mean gestational age at delivery
From 16-20 weeks gestation through preterm delivery
Mean Neonatal Birth Weight
Time Frame: At delivery
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

December 24, 2007

Study Record Updates

Last Update Posted (Actual)

May 19, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Progesterone75,643

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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