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

CompletedOBSERVATIONAL
Enrollment

245

Participants

Timeline

Start Date

November 9, 2010

Primary Completion Date

August 13, 2020

Study Completion Date

August 13, 2020

Conditions
Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial
Interventions
DRUG

ASQ-3, Bayley III, Neurologic exam

Developmental Scales of infant development - Children born to mothers who participated in the 17P-ES-003 study will be enrolled in this study and evaluated using the ASQ-3. Those meeting protocol criteria based on ASQ-3, will be evaluated using the Bayley III and have a neurologic examination.

Trial Locations (40)

4032

Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészeti és Nogyógyászati Klinika, Debrecen

4400

Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft., Nyíregyháza

6725

Szegedi Tudományegyetem Szülészeti és Nogyógyászati Klinika, Szeged

9023

Petz Aladár Megyei Oktató Kórház, Győr

11009

Hospital Universitario Puerta Del Mar, Cadiz

21014

Steven Z Lenowitz, MD, LLC, Bel Air

23708

Naval Medical Center, Portsmouth

27103

Lyndhurst Gynecologic Associates, Winston-Salem

Triad Research Partners, LLC, Winston-Salem

29201

SC Clinical Research Center, LLC, Columbia

35016

Hospital Universitario Materno Infantil de Canarias, Las Palmas de Gran Canaria

36106

Drug Research Analysis Corp, Montgomery

38104

Women's Physician Group, Memphis

40202

University of Louisville School of Medicine, Louisville

40207

Women's Care Physicians/Obstetrical Specialists, PLLC, Louisville

46009

Hospital Universitario La Fe, Servicio de Neonatologia, Valencia

48604

Saginaw Valley Medical Research Group, LLC/Women's OB GYN, PC, Saginaw

50005

Fakultni nemocnice Hradec Králové, Hradec Králové

63110

Washington University School of Medicine, St Louis

75320

Practice Research Organization, Inc., Dallas

78236

Wilford Hall Medical Center, Lackland Air Force Base

80903

Women's Associates, Colorado Springs

83404

Women's Healthcare Associates dba Rosemark WomenCare Specialists, Idaho Falls

83712

The Women's Clinic, Boise

84041

Tanner Clinic, Layton

84062

Central Utah Clinic, Division of Mt. Timpanogos Women's Health Care, Pleasant Grove

84070

Salt Lake Women's Center, PC, Sandy City

85712

Watching Over Mothers and Babies Foundation, Tucson

91942

Grossmont Center for Clinical Research, La Mesa

92124

Naval Medical Center San Diego, San Diego

96859

Tripler Army Medical Center, Honolulu

98431

Madigan Army Medical Center, Tacoma

195257

State Educational Institution Saint Petersburg I.I. Mechnikov State Medical Academy of RosZdrav, Saint Petersburg

420012

Kazan State Medical University, Kazan'

660100

Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky, Krasnoyarsk

K1H8L6

The Ottawa Hospital, Ottawa

N8X 3V6

Medicine Professional Corporation Obstetrics and Gynaecology, Windsor

708 52

Fakultní Nemocnice Ostrava, Ostrava

08035

Hospital Vall d'Hebrón, Barcelona

02050

Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Sciences of Ukraine, Kiev

Sponsors
All Listed Sponsors
collaborator

Registrat-Mapi

OTHER

lead

AMAG Pharmaceuticals, Inc.

INDUSTRY