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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
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).
Details
| Lead sponsor | AMAG Pharmaceuticals, Inc. |
|---|---|
| Status | COMPLETED |
| Enrolment | 245 |
| Start date | Tue Nov 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Aug 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial
Interventions
- ASQ-3, Bayley III, Neurologic exam
Countries
Russia, Ukraine, Hungary, Canada, United States, Spain, Czechia