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Completed

NCT Number: NCT01180296

Oral Progesterone for Prevention of Preterm Birth

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Miami Valley HospitaL

Dayton, Ohio, 45409, United States

About this study

To evaluate whether 400 mg daily oral micronized progesterone from 16 to 34 weeks' is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Oral Micronized Progesterone

Drug

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

Other names: Prometrium(TM)

Identical Placebo tablet

Drug

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

Other names: Placebo

Primary outcomes

  1. Rate of Recurrent Preterm Birth

    Time frame: Prior to 37 weeks' gestation

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

Secondary outcomes

  1. Secondary Outcomes

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

    Serum progesterone levels

Sponsors and collaborators

Lead sponsor

Fetal Medicine Foundation

Other

Registry information

Official study title

Prevention of Recurrent Preterm Birth With Micronized Progesterone

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 12, 2010
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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