Vaginal Progesterone Versus Placebo in Multiple Pregnancy

This study has been completed.
Sponsor:
Collaborators:
Calgary Health Region
Columbia Laboratories
Information provided by (Responsible Party):
Dr. Sue Ross, University of Calgary
ClinicalTrials.gov Identifier:
NCT00343265
First received: June 20, 2006
Last updated: August 14, 2013
Last verified: August 2013

June 20, 2006
August 14, 2013
June 2006
March 2011   (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
Not Provided
Not Provided
 
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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Preterm Birth
  • Drug: Vaginal progesterone gel
    Vaginal gel once daily
  • Drug: Placebo gel
    once daily
  • Active Comparator: 1
    Progesterone gel
    Intervention: Drug: Vaginal progesterone gel
  • Placebo Comparator: 2
    Vaginal gel with no medication
    Intervention: Drug: Placebo gel
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 Jul 14. doi:pii: /j/jpme.ahead-of-print/jpm-2012-0057/jpm-2012-0057.xml. 10.1515/jpm-2012-0057. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
March 2011
March 2011   (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 information is only displayed when the study is recruiting subjects
Canada
 
NCT00343265
18589, 9427-U0206-47C, 104425
No
Dr. Sue Ross, University of Calgary
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
August 2013

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