Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial
Conditions
Keywords
17P Efficacy Trial Follow up
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, 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.
Interventions
DRUGASQ-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.
Sponsors
Registrat-Mapi
AMAG Pharmaceuticals, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Months to 25 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | aged 23 to 25 months | 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. |
Countries
Canada, Czechia, Hungary, Russia, Spain, Ukraine, United States
Outcome results
None listed