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
NCT ID: NCT01146990
Last Updated: 2022-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
245 participants
OBSERVATIONAL
2010-11-09
2020-08-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Infants Born to Mothers in the 17P-ES-003 Study
Infants Born to Mothers Who Participated in the 17P-ES-003 Study and whose mothers consented for them to be followed for this study.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2\. During their involvement in the above protocol, mothers must have received at least one dose of study drug (Safety population).
3\. Children between 22 and 25 months of age adjusted for gestational age.
Exclusion Criteria
22 Months
25 Months
ALL
No
Sponsors
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Registrat-Mapi
OTHER
AMAG Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Medicine Professional Corporation Obstetrics and Gynaecology
Windsor, Ontario, Canada
Fakultni nemocnice Hradec Králové
Hradec Králové, , Czechia
Fakultní Nemocnice Ostrava
Ostrava, , Czechia
Szegedi Tudományegyetem Szülészeti és Nogyógyászati Klinika
Szeged, Csongrád megye, Hungary
Petz Aladár Megyei Oktató Kórház
Győr, Győr-Moson-Sopron, Hungary
Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészeti és Nogyógyászati Klinika
Debrecen, Hajdú-Bihar, Hungary
Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Kazan State Medical University
Kazan', , Russia
Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky
Krasnoyarsk, , Russia
State Educational Institution Saint Petersburg I.I. Mechnikov State Medical Academy of RosZdrav
Saint Petersburg, , Russia
Hospital Vall d'Hebrón
Barcelona, , Spain
Hospital Universitario Puerta Del Mar
Cadiz, , Spain
Hospital Universitario Materno Infantil de Canarias
Las Palmas de Gran Canaria, , Spain
Hospital Universitario La Fe, Servicio de Neonatologia
Valencia, , Spain
Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Sciences of Ukraine
Kiev, , Ukraine
Countries
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Other Identifiers
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17P-FU-004
Identifier Type: -
Identifier Source: org_study_id
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