NCT00343265

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2006

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

August 15, 2013

Status Verified

August 1, 2013

Enrollment Period

4.8 years

First QC Date

June 20, 2006

Last Update Submit

August 14, 2013

Conditions

Preterm Birth

Keywords

Preterm birthMultiple pregnancyVaginal progesteronePreterm birth in multiple pregnancy

Outcome Measures

Primary Outcomes (1)

  • Gestational age

    Delivery

Secondary Outcomes (8)

  • Proportion of women delivering < 35 weeks

    Delivery

  • Proportion of women delivering < 37 weeks

    Delivery

  • Proportion of women having spontaneous preterm delivery

    Delivery

  • Proportion of women having tocolytic therapy

    During pregnancy

  • Treatment compliance

    Delivery

  • +3 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Progesterone gel

Drug: Vaginal progesterone gel

2

PLACEBO COMPARATOR

Vaginal gel with no medication

Drug: Placebo gel

Interventions

Vaginal progesterone gelDRUG

Vaginal gel once daily

1
Placebo gelDRUG

once daily

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed multiple pregnancy
  • Ultrasound confirmed minimum of 2 live fetuses
  • Gestational age 16-20 6/7 weeks

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Calgary Health Region

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 23093256RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Stephen Wood, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

  • Sue Ross, PhD

    University of Calgary

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

June 20, 2006

First Posted

June 22, 2006

Study Start

June 1, 2006

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

August 15, 2013

Record last verified: 2013-08

Locations

CA(1)