National Institute of Child Health and Human Development
Maternal Fetal Medicine Units Network

A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate
for Prevention of Preterm Birth in Multifetal Gestation

Related Publications & Presentations
Twin Pregnancy

Objective

To determine whether 17 Alpha-Hydroxyprogesterone prevents preterm birth in multifetal pregnancies.

Project Status

Recruiting has been completed.

Clinical Centers

Magee Women's, Alabama, Wayne State, Wake Forest, Ohio State, Texas-Dallas, Utah, Drexel, Brown, Columbia, Case Western Reserve, Texas-Houston, UNC, Northwestern

Type

Double masked randomized controlled trial

Major Eligibility Criteria

• Twin or triplet pregnancy
• Gestational age 16-20 weeks
• No previous fetal reduction except quads to triplets
• Absence of fetal anomalies

Groups

• Active: 1 ml IM with 250 mg of 17 a-hydroxyprogesterone caproate weekly
• Placebo: 1 ml IM inert oil weekly

Sample Size

Trial goals: 600 twin and 120 triplet pregnancies

Management Protocols

• Coded medication
• Weekly injection (250mg) or placebo until 35 weeks

Outcome Measures

• Primary:
• Preterm delivery (<35 weeks gestation)
• Secondary:
• Randomization to delivery interval
• Tocolytic therapy
• Hospital admissions for preterm labor
• Cerclage placement
• Neonatal morbidity and mortality

Timetable

• Enrollment: Feb 2004 - Feb 2008
• Data Collection: Feb 2004 - Aug 2008
• Closeout/final analysis: Oct 2008 - Apr 2009