Status:
COMPLETED
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
Lead Sponsor:
AMAG Pharmaceuticals, Inc.
Collaborating Sponsors:
Registrat-Mapi
Conditions:
Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial
Eligibility:
All Genders
22-25 years
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, b...
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...
Eligibility Criteria
Inclusion
- 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
- 1\. There is no parent/legal guardian available to sign an informed consent. 2. Born to women who are unblinded to study group assignment.
Key Trial Info
Start Date :
November 9 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 13 2020
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT01146990
Start Date
November 9 2010
End Date
August 13 2020
Last Update
May 18 2022
Active Locations (40)
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1
Drug Research Analysis Corp
Montgomery, Alabama, United States, 36106
2
Watching Over Mothers and Babies Foundation
Tucson, Arizona, United States, 85712
3
Grossmont Center for Clinical Research
La Mesa, California, United States, 91942
4
Naval Medical Center San Diego
San Diego, California, United States, 92124