Vaginal Progesterone Versus Placebo in Multiple Pregnancy | NCT00343265

Studies
Vaginal Progesterone Versus Placebo in Multiple Pregnancy

NCT00343265

Sponsor

University of Calgary

Status

Completed

Last Update Posted

Aug 15, 2013Estimated

Enrollment

84Actual

Phase

Not Applicable

Conditions

Preterm Birth

Interventions

Vaginal progesterone gel
Placebo gel

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Jun 20, 2006

First Submission Date that Met QC Criteria

Jun 20, 2006

First Posted Date

Jun 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2013

Last Update Posted Date

Aug 15, 2013Estimated

Name	Class
Calgary Health Region	OTHER
Juniper Pharmaceuticals, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Progesterone gel	Drug: Vaginal progesterone gel
2	Placebo Comparator	Vaginal gel with no medication	Drug: Placebo gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vaginal progesterone gel	Drug	Vaginal gel once daily	1
Placebo gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gestational age		Delivery

Secondary Outcomes

Measure	Description	Time Frame
Proportion of women delivering < 35 weeks		Delivery
Proportion of women delivering < 37 weeks		Delivery
Proportion of women having spontaneous preterm delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Wood, MD	University of Calgary	Principal Investigator
Sue Ross, PhD	University of Calgary	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Calgary Health Region		Calgary	Alberta	T2N 2T9	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23093256	Result	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.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Type	Description	Link
9427-U0206-47C
104425