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Vaginal Progesterone Versus Placebo in Multiple Pregnancy
This study is currently recruiting participants.
Study NCT00343265   Information provided by University of Calgary
First Received: June 20, 2006   Last Updated: February 25, 2009   History of Changes

June 20, 2006
February 25, 2009
June 2006
June 2010   (final data collection date for primary outcome measure)
Gestational age [ Time Frame: Delivery ] [ Designated as safety issue: No ]
Gestational age
Complete list of historical versions of study NCT00343265 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
 
Vaginal Progesterone Versus Placebo in Multiple Pregnancy
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.

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.

 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Preterm Birth
Drug: Vaginal progesterone gel and placebo gel
  • Active Comparator: Progesterone gel
  • Placebo Comparator: Vaginal gel with no medication
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Stephen Wood, MD 403 944-2017 stephen.wood@albertahealthservices.ca
Contact: Leslie Millar, RN 403 944-4440 leslie.millar@albertahealthservices.ca
Canada
 
NCT00343265
Dr. Stephen Wood, University of Calgary
18589, 9427-U0206-47C, 104425
University of Calgary
  • Calgary Health Region
  • Columbia Laboratories
Principal Investigator: Stephen Wood, MD University of Calgary
Study Director: Sue Ross, PhD University of Calgary
University of Calgary
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP