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Vaginal Progesterone Versus Placebo in Multiple Pregnancy

NCT ID: NCT00343265

Last Updated: 2013-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Preterm Birth

Keywords

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Preterm birth Multiple pregnancy Vaginal progesterone Preterm birth in multiple pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Progesterone gel

Group Type ACTIVE_COMPARATOR

Vaginal progesterone gel

Intervention Type DRUG

Vaginal gel once daily

2

Vaginal gel with no medication

Group Type PLACEBO_COMPARATOR

Placebo gel

Intervention Type DRUG

once daily

Interventions

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Vaginal progesterone gel

Vaginal gel once daily

Intervention Type DRUG

Placebo gel

once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Calgary Health Region

OTHER

Sponsor Role collaborator

Juniper Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sue Ross

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen Wood, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Sue Ross, PhD

Role: STUDY_DIRECTOR

University of Calgary

Locations

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Calgary Health Region

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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Wood S, Ross S, Tang S, Miller L, Sauve R, Brant R. Vaginal progesterone to prevent preterm birth in multiple pregnancy: a randomized controlled trial. J Perinat Med. 2012 Nov;40(6):593-9. doi: 10.1515/jpm-2012-0057.

Reference Type RESULT
PMID: 23093256 (View on PubMed)

Other Identifiers

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9427-U0206-47C

Identifier Type: -

Identifier Source: secondary_id

104425

Identifier Type: -

Identifier Source: secondary_id

18589

Identifier Type: -

Identifier Source: org_study_id