Completed

NCT Number: NCT01146990

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

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).

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Key information

Conditions

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

Age range

22 month–25 month

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ottawa Hospital, Ottawa, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

During their involvement in the above protocol, mothers must have received at least one dose of study drug (Safety population).

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.

Treatment and study plan

ASQ-3, Bayley III, Neurologic exam

Drug

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.

Primary outcomes

Determine whether there is a difference in developmental status between children whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial

Time frame: aged 23 to 25 months

The primary objective of this study is to determine whether there is a difference in developmental status between children, aged 23 to 25 months after adjustment for gestational age, whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial.

Sponsors and collaborators

Lead sponsor

AMAG Pharmaceuticals, Inc.

Industry

Collaborators

Registrat-Mapi

Registry information

Important dates

Study start: 2010
Primary completion: 2020
Study completion: 2020
First posted: Jun 22, 2010
Registry last updated: May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.