Vaginal Progesterone Versus Placebo in Multiple Pregnancy

August 14, 2013 updated by: Dr. Sue Ross, University of Calgary

Pilot Randomized Trial of Vaginal Progesterone to Prevent Preterm Birth in Multiple Pregnancy

The purpose of this study is to see if daily use of vaginal progesterone will prevent preterm birth in women carrying 2 or more babies.

Study Overview

Status

Completed

Conditions

Detailed Description

Women who are pregnant with twins or any higher order multiple will be approached to take part. Women will be randomized to get either vaginal progesterone gel or a placebo gel daily from study entry until 35 6/7 weeks. Women can enter the study between 16 - 20 6/7 weeks. Two hundred women will be recruited to take part. Data will be collected on the women and their infants to see if the active medication prolongs pregnancy.

Study Type

Interventional

Enrollment (Actual)

84

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

    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Calgary Health Region

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Confirmed multiple pregnancy
  • Ultrasound confirmed minimum of 2 live fetuses
  • Gestational age 16-20 6/7 weeks

Exclusion Criteria:

  • Placenta previa
  • Pre-existing hypertension
  • Major fetal anomaly
  • Monoamniotic, monozygotic multiples
  • Maternal seizure disorder
  • History of, or active, thromboembolic disease
  • Maternal live disease
  • Breast malignancy or pathology
  • Progesterone dependent neoplasia
  • Plans to move to another city during pregnancy
  • Sensitivity to progesterone
  • Participation in other clinical trials during the 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Progesterone gel
Vaginal gel once daily
Placebo Comparator: 2
Vaginal gel with no medication
once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gestational age
Time Frame: Delivery
Delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of women delivering < 35 weeks
Time Frame: Delivery
Delivery
Proportion of women delivering < 37 weeks
Time Frame: Delivery
Delivery
Proportion of women having spontaneous preterm delivery
Time Frame: Delivery
Delivery
Proportion of women having tocolytic therapy
Time Frame: During pregnancy
During pregnancy
Treatment compliance
Time Frame: Delivery
Delivery
Length of stay for mother and infants
Time Frame: Discharge
Discharge
Infant morbidity and mortality
Time Frame: Discharge
Discharge
Birth weight
Time Frame: Birth
Birth

Collaborators and Investigators

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

Investigators

  • Study Director: Sue Ross, PhD, University of Calgary
  • Principal Investigator: Stephen Wood, MD, University of Calgary

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.

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

June 1, 2006

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

June 20, 2006

First Submitted That Met QC Criteria

June 20, 2006

First Posted (Estimate)

June 22, 2006

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 14, 2013

Last Verified

August 1, 2013

More Information

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.

Clinical Trials on Preterm Birth

Clinical Trials on Vaginal progesterone gel

Subscribe