Vaginal Progesterone Versus Placebo in Multiple Pregnancy - Full Text View

Sponsor:	University of Calgary
Collaborators:	Calgary Health Region Columbia Laboratories
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00343265

Purpose

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.

Condition	Intervention
Preterm Birth	Drug: Vaginal progesterone gel Drug: Placebo gel

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Pilot Randomized Trial of Vaginal Progesterone to Prevent Preterm Birth in Multiple Pregnancy

Resource links provided by NLM:

Drug Information available for: Progesterone

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:

Gestational age [ Time Frame: Delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of women delivering < 35 weeks [ Time Frame: Delivery ] [ Designated as safety issue: No ]
Proportion of women delivering < 37 weeks [ Time Frame: Delivery ] [ Designated as safety issue: No ]
Proportion of women having spontaneous preterm delivery [ Time Frame: Delivery ] [ Designated as safety issue: No ]
Proportion of women having tocolytic therapy [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
Treatment compliance [ Time Frame: Delivery ] [ Designated as safety issue: No ]
Length of stay for mother and infants [ Time Frame: Discharge ] [ Designated as safety issue: No ]
Infant morbidity and mortality [ Time Frame: Discharge ] [ Designated as safety issue: No ]
Birth weight [ Time Frame: Birth ] [ Designated as safety issue: No ]

Enrollment:	84
Study Start Date:	June 2006
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Progesterone gel	Drug: Vaginal progesterone gel Vaginal gel once daily
Placebo Comparator: 2 Vaginal gel with no medication	Drug: Placebo gel once daily

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343265

Locations

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

Sponsors and Collaborators

University of Calgary

Calgary Health Region

Columbia Laboratories

Investigators

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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dr. Stephen Wood, University of Calgary
ClinicalTrials.gov Identifier:	NCT00343265 History of Changes
Other Study ID Numbers:	18589, 9427-U0206-47C, 104425
Study First Received:	June 20, 2006
Last Updated:	September 1, 2011
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:

Preterm birth
Multiple pregnancy
Vaginal progesterone
Preterm birth in multiple pregnancy

Additional relevant MeSH terms:

Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone

Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012