Trials / Completed
CompletedNCT01146990
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
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 245 (actual)
- Sponsor
- AMAG Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 22 Months – 25 Months
- Healthy volunteers
- Not accepted
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, born to mothers who participated in the 17P Efficacy Trial sponsored by Hologic (Protocol number 17P-ES-003).
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ASQ-3, Bayley III, Neurologic exam | 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. |
Timeline
- Start date
- 2010-11-09
- Primary completion
- 2020-08-13
- Completion
- 2020-08-13
- First posted
- 2010-06-22
- Last updated
- 2022-05-18
Locations
40 sites across 7 countries: United States, Canada, Czechia, Hungary, Russia, Spain, Ukraine
Source: ClinicalTrials.gov record NCT01146990. Inclusion in this directory is not an endorsement.