Vaginal Progesterone Versus Placebo in Multiple Pregnancy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00343265

Enrollment

Registered

2006-06-22

Start date

2006-06-30

Completion date

2011-03-31

Last updated

2013-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Keywords

Preterm birth, Multiple pregnancy, Vaginal progesterone, Preterm birth in multiple pregnancy

Brief 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.

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.

Interventions

DRUGVaginal progesterone gel

Vaginal gel once daily

DRUGPlacebo gel

once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Gestational age	Delivery

Secondary

Measure	Time frame
Proportion of women delivering < 37 weeks	Delivery
Proportion of women having spontaneous preterm delivery	Delivery
Proportion of women having tocolytic therapy	During pregnancy
Proportion of women delivering < 35 weeks	Delivery
Length of stay for mother and infants	Discharge
Infant morbidity and mortality	Discharge
Birth weight	Birth
Treatment compliance	Delivery

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026