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

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.