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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: ASQ-3, Bayley III, Neurologic exam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Months
Maximum Age: 25 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants Born to Mothers in the 17P-ES-003 Study<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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17P Efficacy Trial Follow up