Vaginal Progesterone Versus Placebo in Multiple Pregnancy

University of Calgary

Status: Completed

Conditions: Preterm Birth

Treatments: Drug: Placebo gel; Drug: Vaginal progesterone gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00343265

9427-U0206-47C

104425

18589

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Progesterone gel

Treatment:

Drug: Vaginal progesterone gel

2

Placebo Comparator group

Description:

Vaginal gel with no medication

Treatment:

Drug: Placebo gel