Last updated on May 2019

A Prospective Noninterventional Follow-Up Study of Children Aged 23 to 25 Months Born to Mothers Who Received Hydroxyprogesterone Caproate Injection 250 mg/mL or Vehicle for Prevention of Preterm Birth


Brief description of study

In the continuing efforts to understand the benefits and risks of in utero exposure to 17P this study is designed to evaluate differences in developmental outcomes of children, aged 23 to 25 months, born to mothers who participated in the 17P Efficacy Trial sponsored by Hologic (Protocol number 17P-ES-003).

Detailed Study Description

This will be a prospective, noninterventional follow-up study designed to provide a developmental assessment of children born to mothers who participated in the 17P Efficacy Trial. When subjects reach an age of 23 months after adjustment for gestational age, they will be screened for developmental delay using the 24 month ASQ version 3. Subjects who score positive (fall below the specified cut-off) for developmental delay in 1 or more domains will be referred for the 24 month Bayley Scales of Infant and Toddler Development (3rd edition, Bayley-III) and a neurological examination.

Clinical Study Identifier: NCT01146990

Find a site near you

Start Over

Drug Research Analysis Corp

Montgomery, AL United States
  Connect »

Naval Medical Center San Diego

San Diego, CA United States
  Connect »

Women's Associates

Colorado Springs, CO United States
  Connect »

Tripler Army Medical Center

Honolulu, HI United States
  Connect »

The Women's Clinic

Boise, ID United States
  Connect »

Steven Z Lenowitz, MD, LLC

Bel Air, MD United States
  Connect »

Triad Research Partners, LLC

Winston-Salem, NC United States
  Connect »

Women's Physician Group

Memphis, TN United States
  Connect »

Wilford Hall Medical Center

Lackland Air Force Base, TX United States
  Connect »

Tanner Clinic

Layton, UT United States
  Connect »

Naval Medical Center

Portsmouth, VA United States
  Connect »

Fakultni nemocnice Hradec Kr lov

Hradec Kralove, Czech Republic
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.