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Vaginal Progesterone Versus Placebo in Multiple Pregnancy

Information source: University of Calgary
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preterm Birth

Intervention: Vaginal progesterone gel (Drug); Placebo gel (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Calgary

Official(s) and/or principal investigator(s):
Stephen Wood, MD, Principal Investigator, Affiliation: University of Calgary
Sue Ross, PhD, Study Director, Affiliation: University of Calgary

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.

Clinical Details

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

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

Primary outcome: Gestational age

Secondary outcome:

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Calgary Health Region, Calgary, Alberta T2N 2T9, Canada
Additional Information

Starting date: June 2006
Last updated: August 14, 2013

Page last updated: August 23, 2015

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