- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00343265
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
Intervention / Treatment
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18589
- 9427-U0206-47C
- 104425
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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