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Completed No phase listed Observational

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

ClinicalTrials.gov ID: NCT01146990

Public ClinicalTrials.gov record NCT01146990. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 1:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01146990
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
AMAG Pharmaceuticals, Inc.
Industry
Enrollment
245 participants

Conditions and interventions

Eligibility (public fields only)

Age range
22 Months to 25 Months
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 8, 2010
Primary completion
Aug 12, 2020
Completion
Aug 12, 2020
Last update posted
May 17, 2022

2010 – 2020

United States locations

U.S. sites
24
U.S. states
17
U.S. cities
22
Facility City State ZIP Site status
Drug Research Analysis Corp Montgomery Alabama 36106
Watching Over Mothers and Babies Foundation Tucson Arizona 85712
Grossmont Center for Clinical Research La Mesa California 91942
Naval Medical Center San Diego San Diego California 92124
Women's Associates Colorado Springs Colorado 80903
Tripler Army Medical Center Honolulu Hawaii 96859
The Women's Clinic Boise Idaho 83712
Women's Healthcare Associates dba Rosemark WomenCare Specialists Idaho Falls Idaho 83404
University of Louisville School of Medicine Louisville Kentucky 40202
Women's Care Physicians/Obstetrical Specialists, PLLC Louisville Kentucky 40207
Steven Z Lenowitz, MD, LLC Bel Air Maryland 21014
Saginaw Valley Medical Research Group, LLC/Women's OB GYN, PC Saginaw Michigan 48604
Washington University School of Medicine St Louis Missouri 63110
Lyndhurst Gynecologic Associates Winston-Salem North Carolina 27103
Triad Research Partners, LLC Winston-Salem North Carolina 27103
SC Clinical Research Center, LLC Columbia South Carolina 29201
Women's Physician Group Memphis Tennessee 38104
Practice Research Organization, Inc. Dallas Texas 75320
Wilford Hall Medical Center Lackland Air Force Base Texas 78236
Tanner Clinic Layton Utah 84041
Central Utah Clinic, Division of Mt. Timpanogos Women's Health Care Pleasant Grove Utah 84062
Salt Lake Women's Center, PC Sandy City Utah 84070
Naval Medical Center Portsmouth Virginia 23708
Madigan Army Medical Center Tacoma Washington 98431

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01146990, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 17, 2022 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01146990 live on ClinicalTrials.gov.

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