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

May 17, 2022 updated by: AMAG Pharmaceuticals, Inc.
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H8L6
        • The Ottawa Hospital
      • Windsor, Ontario, Canada, N8X 3V6
        • Medicine Professional Corporation Obstetrics and Gynaecology
  • Czechia
      • Hradec Kralove, Czechia, 50005
        • Fakultní nemocnice Hradec Králové
      • Ostrava, Czechia, 708 52
        • Fakultni nemocnice Ostrava
  • Hungary
    • Csongrad
      • Szeged, Csongrad, Hungary, 6725
        • Szegedi Tudományegyetem Szülészeti és Nogyógyászati Klinika
    • Gyor-moson-sopron
      • Gyor, Gyor-moson-sopron, Hungary, 9023
        • Petz Aladár Megyei Oktató Kórház
    • Hajdu-bihar
      • Debrecen, Hajdu-bihar, Hungary, 4032
        • Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészeti és Nogyógyászati Klinika
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.
  • Russian Federation
      • Kazan, Russian Federation, 420012
        • Kazan State Medical University
      • Krasnoyarsk, Russian Federation, 660100
        • Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky
      • Saint Petersburg, Russian Federation, 195257
        • State Educational Institution Saint Petersburg I.I. Mechnikov State Medical Academy of RosZdrav
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Cadiz, Spain, 11009
        • Hospital Universitario Puerta Del Mar
      • Las Palmas de Gran Canaria, Spain, 35016
        • Hospital Universitario Materno Infantil de Canarias
      • Valencia, Spain, 46009
        • Hospital Universitario La Fe, Servicio de Neonatologia
  • Ukraine
      • Kiev, Ukraine, 02050
        • Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Sciences of Ukraine
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36106
        • Drug Research Analysis Corp
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Watching Over Mothers and Babies Foundation
    • California
      • La Mesa, California, United States, 91942
        • Grossmont Center for Clinical Research
      • San Diego, California, United States, 92124
        • Naval Medical Center San Diego
    • Colorado
      • Colorado Springs, Colorado, United States, 80903
        • Women's Associates
    • Hawaii
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center
    • Idaho
      • Boise, Idaho, United States, 83712
        • The Women's Clinic
      • Idaho Falls, Idaho, United States, 83404
        • Women's Healthcare Associates dba Rosemark WomenCare Specialists
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville School of Medicine
      • Louisville, Kentucky, United States, 40207
        • Women's Care Physicians/Obstetrical Specialists, PLLC
    • Maryland
      • Bel Air, Maryland, United States, 21014
        • Steven Z Lenowitz, MD, LLC
    • Michigan
      • Saginaw, Michigan, United States, 48604
        • Saginaw Valley Medical Research Group, LLC/Women's OB GYN, PC
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Gynecologic Associates
      • Winston-Salem, North Carolina, United States, 27103
        • Triad Research Partners, LLC
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • SC Clinical Research Center, LLC
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Women's Physician Group
    • Texas
      • Dallas, Texas, United States, 75320
        • Practice Research Organization, Inc.
      • Lackland Air Force Base, Texas, United States, 78236
        • Wilford Hall Medical Center
    • Utah
      • Layton, Utah, United States, 84041
        • Tanner Clinic
      • Pleasant Grove, Utah, United States, 84062
        • Central Utah Clinic, Division of Mt. Timpanogos Women's Health Care
      • Sandy, Utah, United States, 84070
        • Salt Lake Women's Center, PC
    • Virginia
      • Portsmouth, Virginia, United States, 23708
        • Naval Medical Center
    • Washington
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: aged 23 to 25 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AMAG Pharmaceuticals, Inc.

Collaborators

Registrat-Mapi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2010

Primary Completion (Actual)

August 13, 2020

Study Completion (Actual)

August 13, 2020

Study Registration Dates

First Submitted

June 16, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17P-FU-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ASQ-3, Bayley III, Neurologic exam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe