Clinical trial NCT01146990: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial
Keywords: 17P Efficacy Trial Follow up
Lead sponsor: AMAG Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Registrat-Mapi
First posted: 2010-06-22
Enrollment: 245
Sex: ALL
Minimum age (years): 22
Maximum age (years): 25
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial

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.

Eligibility criteria: Inclusion Criteria:

* 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.

  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:

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

Primary outcomes:
measure: 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
timeFrame: aged 23 to 25 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Drug Research Analysis Corp
state: Alabama
city: Tucson
country: United States
facility: Watching Over Mothers and Babies Foundation
state: Arizona
city: La Mesa
country: United States
facility: Grossmont Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Colorado Springs
country: United States
facility: Women's Associates
state: Colorado
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Boise
country: United States
facility: The Women's Clinic
state: Idaho
city: Idaho Falls
country: United States
facility: Women's Healthcare Associates dba Rosemark WomenCare Specialists
state: Idaho
city: Louisville
country: United States
facility: University of Louisville School of Medicine
state: Kentucky
city: Louisville
country: United States
facility: Women's Care Physicians/Obstetrical Specialists, PLLC
state: Kentucky
city: Bel Air
country: United States
facility: Steven Z Lenowitz, MD, LLC
state: Maryland
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group, LLC/Women's OB GYN, PC
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Winston-Salem
country: United States
facility: Lyndhurst Gynecologic Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Triad Research Partners, LLC
state: North Carolina
city: Columbia
country: United States
facility: SC Clinical Research Center, LLC
state: South Carolina
city: Memphis
country: United States
facility: Women's Physician Group
state: Tennessee
city: Dallas
country: United States
facility: Practice Research Organization, Inc.
state: Texas
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Medical Center
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Pleasant Grove
country: United States
facility: Central Utah Clinic, Division of Mt. Timpanogos Women's Health Care
state: Utah
city: Sandy
country: United States
facility: Salt Lake Women's Center, PC
state: Utah
city: Portsmouth
country: United States
facility: Naval Medical Center
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Windsor
country: Canada
facility: Medicine Professional Corporation Obstetrics and Gynaecology
state: Ontario
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Králové
city: Ostrava
country: Czechia
facility: Fakultní Nemocnice Ostrava
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szülészeti és Nogyógyászati Klinika
state: Csongrad
city: Gyor
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház
state: Gyor-moson-sopron
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészeti és Nogyógyászati Klinika
state: Hajdu-bihar
city: Nyíregyháza
country: Hungary
facility: Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.
state: Szabolcs-Szatmár-Bereg
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky
city: Saint Petersburg
country: Russian Federation
facility: State Educational Institution Saint Petersburg I.I. Mechnikov State Medical Academy of RosZdrav
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta Del Mar
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Materno Infantil de Canarias
city: Valencia
country: Spain
facility: Hospital Universitario La Fe, Servicio de Neonatologia
city: Kiev
country: Ukraine
facility: Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Sciences of Ukraine
Study officials:
References: