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Vaginal Progesterone Versus Placebo in Multiple Pregnancy

Primary Purpose

Preterm Birth

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Vaginal progesterone gel

Placebo gel

About this trial

This is an interventional treatment trial for Preterm Birth focused on measuring Preterm birth, Multiple pregnancy, Vaginal progesterone, Preterm birth in multiple pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Calgary Health Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Progesterone gel

Vaginal gel with no medication

Outcomes

Primary Outcome Measures

Gestational age

Secondary Outcome Measures

Proportion of women delivering < 35 weeks

Proportion of women delivering < 37 weeks

Proportion of women having spontaneous preterm delivery

Proportion of women having tocolytic therapy

Treatment compliance

Length of stay for mother and infants

Infant morbidity and mortality

Birth weight

Full Information

NCT ID

NCT00343265

First Posted

June 20, 2006

Last Updated

August 14, 2013

Sponsor

University of Calgary

Collaborators

Calgary Health Region, Juniper Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00343265

Brief Title

Vaginal Progesterone Versus Placebo in Multiple Pregnancy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Calgary

Collaborators

Calgary Health Region, Juniper Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

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

Preterm Birth

Keywords

Preterm birth, Multiple pregnancy, Vaginal progesterone, Preterm birth in multiple pregnancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Progesterone gel

Arm Title

Arm Type

Placebo Comparator

Arm Description

Vaginal gel with no medication

Intervention Type

Drug

Intervention Name(s)

Vaginal progesterone gel

Intervention Description

Vaginal gel once daily

Intervention Type

Drug

Intervention Name(s)

Placebo gel

Intervention Description

once daily

Primary Outcome Measure Information:

Title

Gestational age

Time Frame

Delivery

Secondary Outcome Measure Information:

Title

Proportion of women delivering < 35 weeks

Time Frame

Delivery

Title

Proportion of women delivering < 37 weeks

Time Frame

Delivery

Title

Proportion of women having spontaneous preterm delivery

Time Frame

Delivery

Title

Proportion of women having tocolytic therapy

Time Frame

During pregnancy

Title

Treatment compliance

Time Frame

Delivery

Title

Length of stay for mother and infants

Time Frame

Discharge

Title

Infant morbidity and mortality

Time Frame

Discharge

Title

Birth weight

Time Frame

Birth

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Wood, MD

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sue Ross, PhD

Organizational Affiliation

University of Calgary

Official's Role

Study Director

Facility Information:

Facility Name

Calgary Health Region

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 2T9

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

23093256

Citation

Wood S, Ross S, Tang S, Miller L, Sauve R, Brant R. Vaginal progesterone to prevent preterm birth in multiple pregnancy: a randomized controlled trial. J Perinat Med. 2012 Nov;40(6):593-9. doi: 10.1515/jpm-2012-0057.

Results Reference

result

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Vaginal Progesterone Versus Placebo in Multiple Pregnancy

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