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
- Conditions
- Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial
- Interventions
- Drug: ASQ-3, Bayley III, Neurologic exam
- Registration Number
- NCT01146990
- Lead Sponsor
- AMAG Pharmaceuticals, Inc.
- Brief Summary
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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 245
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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.
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During their involvement in the above protocol, mothers must have received at least one dose of study drug (Safety population).
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Children between 22 and 25 months of age adjusted for gestational age.
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- There is no parent/legal guardian available to sign an informed consent. 2. Born to women who are unblinded to study group assignment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Infants Born to Mothers in the 17P-ES-003 Study ASQ-3, Bayley III, Neurologic exam Infants Born to Mothers Who Participated in the 17P-ES-003 Study and whose mothers consented for them to be followed for this study.
- Primary Outcome Measures
Name Time Method Determine whether there is a difference in developmental status between children whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial aged 23 to 25 months The primary objective of this study is to determine whether there is a difference in developmental status between children, aged 23 to 25 months after adjustment for gestational age, whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
Women's Healthcare Associates dba Rosemark WomenCare Specialists
🇺🇸Idaho Falls, Idaho, United States
Practice Research Organization, Inc.
🇺🇸Dallas, Texas, United States
Saginaw Valley Medical Research Group, LLC/Women's OB GYN, PC
🇺🇸Saginaw, Michigan, United States
Grossmont Center for Clinical Research
🇺🇸La Mesa, California, United States
Wilford Hall Medical Center
🇺🇸Lackland Air Force Base, Texas, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészeti és Nogyógyászati Klinika
ðŸ‡ðŸ‡ºDebrecen, Hajdu-bihar, Hungary
Drug Research Analysis Corp
🇺🇸Montgomery, Alabama, United States
Watching Over Mothers and Babies Foundation
🇺🇸Tucson, Arizona, United States
Naval Medical Center San Diego
🇺🇸San Diego, California, United States
Women's Associates
🇺🇸Colorado Springs, Colorado, United States
The Women's Clinic
🇺🇸Boise, Idaho, United States
University of Louisville School of Medicine
🇺🇸Louisville, Kentucky, United States
Steven Z Lenowitz, MD, LLC
🇺🇸Bel Air, Maryland, United States
Women's Care Physicians/Obstetrical Specialists, PLLC
🇺🇸Louisville, Kentucky, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Lyndhurst Gynecologic Associates
🇺🇸Winston-Salem, North Carolina, United States
Triad Research Partners, LLC
🇺🇸Winston-Salem, North Carolina, United States
Women's Physician Group
🇺🇸Memphis, Tennessee, United States
SC Clinical Research Center, LLC
🇺🇸Columbia, South Carolina, United States
Salt Lake Women's Center, PC
🇺🇸Sandy, Utah, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
Central Utah Clinic, Division of Mt. Timpanogos Women's Health Care
🇺🇸Pleasant Grove, Utah, United States
Naval Medical Center
🇺🇸Portsmouth, Virginia, United States
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Medicine Professional Corporation Obstetrics and Gynaecology
🇨🇦Windsor, Ontario, Canada
Fakultni nemocnice Hradec Králové
🇨🇿Hradec Kralove, Czechia
Fakultnà Nemocnice Ostrava
🇨🇿Ostrava, Czechia
Szegedi Tudományegyetem Szülészeti és Nogyógyászati Klinika
ðŸ‡ðŸ‡ºSzeged, Csongrad, Hungary
Petz Aladár Megyei Oktató Kórház
ðŸ‡ðŸ‡ºGyor, Gyor-moson-sopron, Hungary
Kazan State Medical University
🇷🇺Kazan, Russian Federation
Hospital Vall d'Hebrón
🇪🇸Barcelona, Spain
State Educational Institution Saint Petersburg I.I. Mechnikov State Medical Academy of RosZdrav
🇷🇺Saint Petersburg, Russian Federation
Hospital Universitario Materno Infantil de Canarias
🇪🇸Las Palmas de Gran Canaria, Spain
Hospital Universitario La Fe, Servicio de Neonatologia
🇪🇸Valencia, Spain
Hospital Universitario Puerta Del Mar
🇪🇸Cadiz, Spain
Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Sciences of Ukraine
🇺🇦Kiev, Ukraine
Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.
ðŸ‡ðŸ‡ºNyÃregyháza, Szabolcs-Szatmár-Bereg, Hungary
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky
🇷🇺Krasnoyarsk, Russian Federation