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Completed

NCT Number: NCT00343265

Vaginal Progesterone Versus Placebo 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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Calgary Health Region

Calgary, Alberta, T2N 2T9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal progesterone gel

Drug

Vaginal gel once daily

Placebo Gel

Drug

once daily

Primary outcomes

  1. Gestational age

    Time frame: Delivery

Secondary outcomes

  1. Proportion of women delivering < 35 weeks

    Time frame: Delivery

  2. Proportion of women delivering < 37 weeks

    Time frame: Delivery

  3. Proportion of women having spontaneous preterm delivery

    Time frame: Delivery

  4. Proportion of women having tocolytic therapy

    Time frame: During pregnancy

  5. Treatment compliance

    Time frame: Delivery

  6. Length of stay for mother and infants

    Time frame: Discharge

  7. Infant morbidity and mortality

    Time frame: Discharge

  8. Birth weight

    Time frame: Birth

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Calgary Health Region
  • Juniper Pharmaceuticals, Inc.

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2006
Registry last updated
Aug 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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