A Prospective 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

Phase 1

• Conditions: This is a prospective, follow-up, designed to provide an assessment of the development of children born to mothers enrolled in the trial of the effectiveness of 17P; MedDRA version: 14.1Level: LLTClassification code 10036594Term: Premature birthSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Health Care [N] - Health Care Quality, Access, and Evaluation [N05]

• Registration Number: EUCTR2011-000105-53-CZ
• Lead Sponsor: KV Pharmaceutical Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-27
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

Each subject must meet the following criteria to be enrolled in this study:
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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 375
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from the study:
1.There is no parent/legal guardian available to sign an informed consent.
2.Born to women who are unblinded to study group assignment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified