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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

NCT01146990 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 245

Last updated 2022-05-18

No results posted yet for this study

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).

Conditions

  • Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial

Interventions

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.

Sponsors & Collaborators

  • Registrat-Mapi

    collaborator OTHER

  • AMAG Pharmaceuticals, Inc.

    lead INDUSTRY

Eligibility

Min Age
22 Months
Max Age
25 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-09
Primary Completion
2020-08-13
Completion
2020-08-13

Countries

  • United States
  • Canada
  • Czechia
  • Hungary
  • Russia
  • Spain
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01146990 on ClinicalTrials.gov