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

NCT01146990 | Completed

• 1 other identifier: 17P-FU-004
• Study Type: observational
• Target: 245
• Locations: 7 countries
• Sites: 40

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).

Conditions

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

Keywords

17P Efficacy Trial Follow up

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  aged 23 to 25 months

Study Arms (1)

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.

Drug: ASQ-3, Bayley III, Neurologic exam

Interventions

ASQ-3, Bayley III, Neurologic exam DRUG

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.

Infants Born to Mothers in the 17P-ES-003 Study

Eligibility Criteria

• Age: 22 Months - 25 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial

You may qualify if:

• \. 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:

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

Sponsors & Collaborators

• AMAG Pharmaceuticals, Inc.: lead
• Registrat-Mapi: collaborator

Study Sites (40)

Drug Research Analysis Corp

Montgomery, Alabama, 36106, United States

Location

Watching Over Mothers and Babies Foundation

Tucson, Arizona, 85712, United States

Location

Grossmont Center for Clinical Research

La Mesa, California, 91942, United States

Location

Naval Medical Center San Diego

San Diego, California, 92124, United States

Location

Women's Associates

Colorado Springs, Colorado, 80903, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

Location

The Women's Clinic

Boise, Idaho, 83712, United States

Location

Women's Healthcare Associates dba Rosemark WomenCare Specialists

Idaho Falls, Idaho, 83404, United States

Location

University of Louisville School of Medicine

Louisville, Kentucky, 40202, United States

Location

Women's Care Physicians/Obstetrical Specialists, PLLC

Louisville, Kentucky, 40207, United States

Location

Steven Z Lenowitz, MD, LLC

Bel Air, Maryland, 21014, United States

Location

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

Saginaw, Michigan, 48604, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, 27103, United States

Location

Triad Research Partners, LLC

Winston-Salem, North Carolina, 27103, United States

Location

SC Clinical Research Center, LLC

Columbia, South Carolina, 29201, United States

Location

Women's Physician Group

Memphis, Tennessee, 38104, United States

Location

Practice Research Organization, Inc.

Dallas, Texas, 75320, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

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

Pleasant Grove, Utah, 84062, United States

Location

Salt Lake Women's Center, PC

Sandy City, Utah, 84070, United States

Location

Naval Medical Center

Portsmouth, Virginia, 23708, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

Medicine Professional Corporation Obstetrics and Gynaecology

Windsor, Ontario, N8X 3V6, Canada

Location

Fakultni nemocnice Hradec Králové

Hradec Králové, 50005, Czechia

Location

Fakultní Nemocnice Ostrava

Ostrava, 708 52, Czechia

Location

Szegedi Tudományegyetem Szülészeti és Nogyógyászati Klinika

Szeged, Csongrád megye, 6725, Hungary

Location

Petz Aladár Megyei Oktató Kórház

Győr, Győr-Moson-Sopron, 9023, Hungary

Location

Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészeti és Nogyógyászati Klinika

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

Kazan State Medical University

Kazan', 420012, Russia

Location

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

Krasnoyarsk, 660100, Russia

Location

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

Saint Petersburg, 195257, Russia

Location

Hospital Vall d'Hebrón

Barcelona, 08035, Spain

Location

Hospital Universitario Puerta Del Mar

Cadiz, 11009, Spain

Location

Hospital Universitario Materno Infantil de Canarias

Las Palmas de Gran Canaria, 35016, Spain

Location

Hospital Universitario La Fe, Servicio de Neonatologia

Valencia, 46009, Spain

Location

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

Kiev, 02050, Ukraine

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 22, 2010
• Study Start: November 9, 2010
• Primary Completion: August 13, 2020
• Study Completion: August 13, 2020
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

CA (2); HU (4); ES (4); CZ (2); RU (3); UA (1); US (24)