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

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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146990
• Other study ID #: 17P-FU-004
• Status: Completed
• Start date: November 9, 2010
• Est. completion date: August 13, 2020

Study information

• Verified date: May 2022
• Source: AMAG Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: August 13, 2020
• Est. primary completion date: August 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Months to 25 Months

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Medicine Professional Corporation Obstetrics and Gynaecology	Windsor	Ontario
Czechia	Fakultni nemocnice Hradec Králové	Hradec Kralove
Czechia	Fakultní Nemocnice Ostrava	Ostrava
Hungary	Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészeti és Nogyógyászati Klinika	Debrecen	Hajdu-bihar
Hungary	Petz Aladár Megyei Oktató Kórház	Gyor	Gyor-moson-sopron
Hungary	Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.	Nyíregyháza	Szabolcs-Szatmár-Bereg
Hungary	Szegedi Tudományegyetem Szülészeti és Nogyógyászati Klinika	Szeged	Csongrad
Russian Federation	Kazan State Medical University	Kazan
Russian Federation	Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky	Krasnoyarsk
Russian Federation	State Educational Institution Saint Petersburg I.I. Mechnikov State Medical Academy of RosZdrav	Saint Petersburg
Spain	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
Ukraine	Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Sciences of Ukraine	Kiev
United States	Steven Z Lenowitz, MD, LLC	Bel Air	Maryland
United States	The Women's Clinic	Boise	Idaho
United States	Women's Associates	Colorado Springs	Colorado
United States	SC Clinical Research Center, LLC	Columbia	South Carolina
United States	Practice Research Organization, Inc.	Dallas	Texas
United States	Tripler Army Medical Center	Honolulu	Hawaii
United States	Women's Healthcare Associates dba Rosemark WomenCare Specialists	Idaho Falls	Idaho
United States	Grossmont Center for Clinical Research	La Mesa	California
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas
United States	Tanner Clinic	Layton	Utah
United States	University of Louisville School of Medicine	Louisville	Kentucky
United States	Women's Care Physicians/Obstetrical Specialists, PLLC	Louisville	Kentucky
United States	Women's Physician Group	Memphis	Tennessee
United States	Drug Research Analysis Corp	Montgomery	Alabama
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	Saginaw Valley Medical Research Group, LLC/Women's OB GYN, PC	Saginaw	Michigan
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Naval Medical Center San Diego	San Diego	California
United States	Salt Lake Women's Center, PC	Sandy	Utah
United States	Madigan Army Medical Center	Tacoma	Washington
United States	Watching Over Mothers and Babies Foundation	Tucson	Arizona
United States	Lyndhurst Gynecologic Associates	Winston-Salem	North Carolina
United States	Triad Research Partners, LLC	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
AMAG Pharmaceuticals, Inc.	Registrat-Mapi

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Hungary,  Russian Federation,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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