NCT01180296

Brief Summary

To evaluate whether daily oral micronized progesterone is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2006

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

November 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2010

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 21, 2011

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

2.2 years

First QC Date

August 10, 2010

Results QC Date

June 22, 2011

Last Update Submit

February 13, 2019

Conditions

Preterm Birth

Keywords

Preterm birth, prevention, progesterone, oral

Outcome Measures

Primary Outcomes (1)

  • Rate of Recurrent Preterm Birth

    Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.

    Prior to 37 weeks' gestation

Secondary Outcomes (1)

  • Secondary Outcomes

    Mean +/- Std Dev gestational age of 25.9/-2.4 weeks in Progesterone group, and 28.4 +/-4.7 weeks in placebo group

Study Arms (2)

Progesterone Group

EXPERIMENTAL

Oral Micronized Progesterone

Drug: oral micronized progesterone

Placebo

PLACEBO COMPARATOR

Identical Placebo Tablet

Drug: Identical Placebo tablet

Interventions

oral micronized progesteroneDRUG

oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks

Also known as: Prometrium(TM)
Progesterone Group
Identical Placebo tabletDRUG

Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks

Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women less than 20 weeks' gestation who had at least one prior spontaneous preterm birth of a liveborn baby between 20 \& 0/7 weeks' and 36 \& 6/7 weeks' gestation.

You may not qualify if:

  • multiple gestations, the presence of major fetal anomalies, progesterone use in the current pregnancy (ongoing or past), the presence of a cervical cerclage, and the presence of a placenta previa.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami Valley HospitaL

Dayton, Ohio, 45409, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Results Point of Contact

Title
David McKenna
Organization
Fetal Medicine Foundation?USA
dsmckenna@mvh.org
937-208-4005

Study Officials

  • David S McKenna, MD

    Fetal Medicine Foundation/USA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

August 10, 2010

First Posted

August 12, 2010

Study Start

November 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 18, 2019

Results First Posted

July 21, 2011

Record last verified: 2019-02

Locations

US(1)