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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

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ClinicalTrials.gov Identifier: NCT01146990
Recruitment Status : Recruiting
First Posted : June 22, 2010
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

Brief 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).

Condition or disease Intervention/treatment
Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial Drug: ASQ-3, Bayley III, Neurologic exam

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 584 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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
Study Start Date : June 2010
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Infants Born to Mothers in the 17P-ES-003 Study
Infants Born to Mothers Who Participated in the 17P-ES-003 Study and whose mothers consented for them to be followed for this study.
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Months to 25 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146990


Contacts
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Contact: Monique Duncan moniqueduncan@amagpharma.com

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Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
Registrat-Mapi

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Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01146990     History of Changes
Other Study ID Numbers: 17P-FU-004
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Keywords provided by AMAG Pharmaceuticals, Inc.:
17P Efficacy Trial Follow up

Additional relevant MeSH terms:
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17 alpha-Hydroxyprogesterone Caproate
11-hydroxyprogesterone
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins
Hormones