Randomized Controlled Trial of Vaginal Progesterone in Wo... | NCT01286246

Studies
Randomized Controlled Trial of Vaginal Progesterone in Women With Threatened Preterm Labor

NCT01286246

Sponsor

University of Calgary

Status

Terminated

Last Update Posted

Jan 8, 2015Estimated

Enrollment

34Actual

Phase

Phase 4

Conditions

Obstetric Labor, Premature

Interventions

Vaginal progesterone
Placebo

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

Jan 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Trial investigators were unable to recruit the estimated sample

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jan 27, 2011

First Submission Date that Met QC Criteria

Jan 27, 2011

First Posted Date

Jan 31, 2011Estimated

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

Jan 7, 2015

Last Update Posted Date

Jan 8, 2015Estimated

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

Prematurity remains the most important single factor in perinatal morbidity and mortality. Unfortunately, the rate of premature delivery is increasing in Canada and is especially high in Alberta with 7.5% of pregnancies ending before 37 weeks gestation. Despite years of research into the causes of spontaneous preterm labor, few effective treatments have been identified. Progesterone is one candidate treatment. The purpose of this study is to investigate whether progesterone can prolong pregnancy in women who have symptoms of preterm labor.

Pregnant women who have symptoms of premature labor will be invited to take part in the study if they are between 22 to 24 weeks pregnant. If they agree to join the study, they will be randomly allocated to either take progesterone 200mg each day via the vagina until 36 weeks, or to take a placebo preparation. Neither the women nor their clinician will know which group they are in.

Women and their babies will be followed until 28 days after the birth, to find out about the length of the pregnancy, any adverse events that might occur (none have been reported in previous trials), and to look at whether women have taken the treatment.

When the study is complete, the results for the progesterone group will be compared to the placebo group. If progesterone is found to be useful in helping to prolong pregnancy, then this will be a possible treatment to help mothers in the future.

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaginal progesterone	Experimental		Drug: Vaginal progesterone
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vaginal progesterone	Drug	Capsules of 200mg micronised progesterone suspended in sunflower oil. One capsule inserted vaginally per day from time of randomisation to gestational age 35(+6)weeks or delivery (if sooner).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gestational age at birth	Gestational age at birth calculated from gestational age at pre-randomization baseline	At birth

Secondary Outcomes

Measure	Description	Time Frame
Proportion of women who have preterm birth <35 weeks		At birth
Proportion of women who have a preterm birth at <37 weeks		At birth
Maternal hospital length of stay (days)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with symptomatic premature contractions successfully arrested for at least 12 hours with tocolytics.
Women with symptoms suggestive of early preterm labor whose contractions resolve without tocolysis but are fetal fibronectin positive.
Gestational age 23(+0)-32(+6) weeks.
Consent to taking part in the study.

Exclusion Criteria:

Placenta previa
Preterm premature rupture of membranes at presentation
Pre-existing hypertension will be excluded in order to reduce the likelihood of iatrogenic preterm delivery within the study women
Known major fetal anomaly detected on ultrasound
Multiple pregnancy
Maternal seizure disorder
Active or history of thromboembolic disease
Maternal liver disease
Known or suspected breast malignancy or pathology
Known or suspected progesterone-dependent neoplasia
Plans to move to another city during pregnancy
Previous participation in a progesterone trial during this pregnancy
Known sensitivity to progesterone

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Wood, MD, MSc	University of Calgary	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Foothills Medical Centre		Calgary	Alberta	T2N 4J8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007752	Obstetric Labor, Premature

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

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Browse Branches

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