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



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:4/17/2018
Start Date:June 2010
End Date:October 2020
Contact:Monique Duncan
Email:moniqueduncan@amagpharma.com

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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).

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.

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.
We found this trial at
25
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34800 Bob Wilson Dr,
San Diego, California 92134
(619) 532-6400
Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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Bel Air, Maryland 21014
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Boise, Idaho 83712
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Colorado Springs, Colorado 80903
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Columbia, South Carolina 29201
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1 Jarrett White Rd
Honolulu, Hawaii 96859
(808) 433-6661
Tripler Army Medical Center The attack of Pearl Harbor led to the construction of Tripler...
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Honolulu, HI
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Idaho Falls, ID
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La Mesa, California 91942
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Lackland Air Force Base, Texas 78236
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Layton, Utah 84041
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Louisville, Kentucky 40202
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Lyndhurst, North Carolina
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Memphis, Tennessee
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Montgomery, Alabama 36106
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1967 Riverside Drive
Ottawa, Ontario K1H 7W9
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Ottawa,
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Pleasant Grove, UT
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Portsmouth, Virginia 23507
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Saginaw, MI
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Sandy, Utah 84070
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9040 Jackson Ave
Tacoma, Washington 98431
(253) 968-1110
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
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1950 South Hawthorne Road
Winston-Salem, North Carolina 27103
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