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Vaginal Progesterone Versus Placebo in Multiple Pregnancy

This study has been completed.
Sponsor:
Collaborators:
Calgary Health Region
Columbia Laboratories
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00343265
First received: June 20, 2006
Last updated: September 1, 2011
Last verified: August 2011
History of Changes
  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:

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 May 16, 2013