Last updated on May 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial
  • Age: Between 1 - 1 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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