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

Completed

Conditions studied: Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial

In brief

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).

Key facts

Study ID

NCT01146990

Run by

AMAG Pharmaceuticals, Inc.

People needed

245

Starts

2010-11-09

Expected to finish

2020-08-13

Last updated by the study team

2022-05-18

Who can join

Age: 2 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Maternal enrollment which resulted in a live birth in the 17P Efficacy Trial: A Multi-center, Randomized, Double-blind Study of Hydroxyprogesterone Caproate Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery.
• During their involvement in the above protocol, mothers must have received at least one dose of study drug (Safety population).
• Children between 22 and 25 months of age adjusted for gestational age.

You may not qualify if…

• 1. There is no parent/legal guardian available to sign an informed consent. 2. Born to women who are unblinded to study group assignment.

Where it is running

• Drug Research Analysis Corp — Montgomery, Alabama, United States
• Watching Over Mothers and Babies Foundation — Tucson, Arizona, United States
• Grossmont Center for Clinical Research — La Mesa, California, United States
• Naval Medical Center San Diego — San Diego, California, United States
• Women's Associates — Colorado Springs, Colorado, United States
• Tripler Army Medical Center — Honolulu, Hawaii, United States
• The Women's Clinic — Boise, Idaho, United States
• Women's Healthcare Associates dba Rosemark WomenCare Specialists — Idaho Falls, Idaho, United States
• University of Louisville School of Medicine — Louisville, Kentucky, United States
• Women's Care Physicians/Obstetrical Specialists, PLLC — Louisville, Kentucky, United States
• Steven Z Lenowitz, MD, LLC — Bel Air, Maryland, United States
• Saginaw Valley Medical Research Group, LLC/Women's OB GYN, PC — Saginaw, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Lyndhurst Gynecologic Associates — Winston-Salem, North Carolina, United States
• Triad Research Partners, LLC — Winston-Salem, North Carolina, United States
• SC Clinical Research Center, LLC — Columbia, South Carolina, United States
• Women's Physician Group — Memphis, Tennessee, United States
• Practice Research Organization, Inc. — Dallas, Texas, United States
• Wilford Hall Medical Center — Lackland Air Force Base, Texas, United States
• Tanner Clinic — Layton, Utah, United States
• Central Utah Clinic, Division of Mt. Timpanogos Women's Health Care — Pleasant Grove, Utah, United States
• Salt Lake Women's Center, PC — Sandy City, Utah, United States
• Naval Medical Center — Portsmouth, Virginia, United States
• Madigan Army Medical Center — Tacoma, Washington, United States
• The Ottawa Hospital — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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