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

A Follow-Up Study of the Children
in the Progesterone Trial

Related Publications & Presentations

Objective

To determine whether there is a difference in achievement of developmental milestones and physical health between children whose mothers received progesterone and those who received placebo in a previous MFMU Network trial.

Conclusion

To be determined

Clinical Centers

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

Study Status

Currently contacting patients who participated in the MFMU Network Progesterone trial.

Major Eligibility Criteria

• Maternal enrollment in the MFMU Network Trial Progesterone Trial at one of the fourteen clinical centers in the fourth MFMU Network cycle (2001 - present)
• Infant discharged alive

Sample Size:

Goal = 348

Assumptions

• Outcome event = ASQ score below cutoff on 1 or more ASQ areas
• Incidence of outcome event in one group = 15%
• Incidence of outcome event in other group = 30%
• Type 1 error = 5% (2-sided)
• Loss to follow-up 20%
• Power ≥ 80%

Scheduled Evaluations/Data Collection

• Pre-Enrollment:
• Confirmation of study child
• Post-Enrollment:
• Ages and Stages Questionnaire
• Survey Questionnaire
• Physical Examination

Outcome Measures

• Primary:
• Ages and Stages Questionnaire score
• Secondary:
• Differences in developmental milestones

Timetable

• As Designed:
• Enrollment: Sept. 2004 - Apr. 2005
• Data Collection: Sept 2004 - May 2005
• Closeout/final Analysis: Jan. 2005 - Jul. 2005