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Vaginal Progesterone Versus Placebo in Multiple Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00343265
Recruitment Status : Completed
First Posted : June 22, 2006
Last Update Posted : August 15, 2013
Calgary Health Region
Juniper Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Dr. Sue Ross, University of Calgary

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.

Condition or disease Intervention/treatment
Preterm Birth Drug: Vaginal progesterone gel Drug: Placebo gel

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Randomized Trial of Vaginal Progesterone to Prevent Preterm Birth in Multiple Pregnancy
Study Start Date : June 2006
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Progesterone gel
Drug: Vaginal progesterone gel
Vaginal gel once daily
Placebo Comparator: 2
Vaginal gel with no medication
Drug: Placebo gel
once daily

Primary Outcome Measures :
  1. Gestational age [ Time Frame: Delivery ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343265

Canada, Alberta
Calgary Health Region
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Calgary Health Region
Juniper Pharmaceuticals, Inc.
Principal Investigator: Stephen Wood, MD University of Calgary
Study Director: Sue Ross, PhD University of Calgary

Responsible Party: Dr. Sue Ross, Adjunct Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00343265     History of Changes
Other Study ID Numbers: 18589
First Posted: June 22, 2006    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: August 2013

Keywords provided by Dr. Sue Ross, University of Calgary:
Preterm birth
Multiple pregnancy
Vaginal progesterone
Preterm birth in multiple pregnancy

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs