Overview

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:
Recruiting

Trial end date:
2020-12-01

Target enrollment:

Participant gender:

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).

Details

Lead Sponsor:

AMAG Pharmaceuticals, Inc.
Lumara Health, Inc.

Collaborator:

Registrat-Mapi

Treatments:

11-hydroxyprogesterone
17-alpha-hydroxy-progesterone caproate