Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Vaginal progesterone gel and placebo gel
  • Vaginal gel once daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Progesterone gel
• Placebo Comparator: 2
  • Vaginal gel with no medication

Primary Measures

• Gestational age
  • Time Frame: Delivery
    Safety Issue?: No

Secondary Measures

• Proportion of women delivering < 35 weeks
  • Time Frame: Delivery
    Safety Issue?: No
• Proportion of women delivering < 37 weeks
  • Time Frame: Delivery
    Safety Issue?: No
• Proportion of women having spontaneous preterm delivery
  • Time Frame: Delivery
    Safety Issue?: No
• Proportion of women having tocolytic therapy
  • Time Frame: During pregnancy
    Safety Issue?: No
• Treatment compliance
  • Time Frame: Delivery
    Safety Issue?: No
• Length of stay for mother and infants
  • Time Frame: Discharge
    Safety Issue?: No
• Infant morbidity and mortality
  • Time Frame: Discharge
    Safety Issue?: No
• Birth weight
  • Time Frame: Birth
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Calgary

Overall Clinical Trial Officials and Contacts

Stephen Wood, MD Principal Investigator University of Calgary  

Overall Contact: Stephen Wood, MD 403 944-2017 stephen.wood@calgaryhealthregion.ca

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00343265

Study ID Number: 18589

ClinicalTrials.gov Identifier: NCT00343265

Health Authority: Canada: Health Canada