Vaginal Progesterone Versus Placebo in Multiple Pregnancy

Preterm Birth Clinical Trial

Official title:

Pilot Randomized Trial of Vaginal Progesterone to Prevent Preterm Birth in Multiple Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343265
• Other study ID #: 18589
• Secondary ID: 9427-U0206-47C10
• Status: Completed
• Phase: N/A
• First received: June 20, 2006
• Last updated: August 14, 2013
• Start date: June 2006
• Est. completion date: March 2011

Study information

• Verified date: August 2013
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Drug:
• Vaginal progesterone gel
Vaginal gel once daily
• Placebo gel
once daily

Locations

Country	Name	City	State
Canada	Calgary Health Region	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Calgary Health Region, Juniper Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 Nov;40(6):593-9. doi: 10.1515/jpm-2012-0057. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational age		Delivery	No
Secondary	Proportion of women delivering < 35 weeks		Delivery	No
Secondary	Proportion of women delivering < 37 weeks		Delivery	No
Secondary	Proportion of women having spontaneous preterm delivery		Delivery	No
Secondary	Proportion of women having tocolytic therapy		During pregnancy	No
Secondary	Treatment compliance		Delivery	No
Secondary	Length of stay for mother and infants		Discharge	No
Secondary	Infant morbidity and mortality		Discharge	No
Secondary	Birth weight		Birth	No