Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01146990
Recruitment Status : Recruiting
First Posted : June 22, 2010
Last Update Posted : July 17, 2020
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

Tracking Information
First Submitted Date June 16, 2010
First Posted Date June 22, 2010
Last Update Posted Date July 17, 2020
Study Start Date June 2010
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2010)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
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).
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial
Condition Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Drug: ASQ-3, Bayley III, Neurologic exam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 14, 2014)
584
Original Estimated Enrollment
 (submitted: June 16, 2010)
375
Estimated Study Completion Date December 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 22 Months to 25 Months   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Clinical Trial Interest 877-233-4781 AMAGCT@druginfo.com
Listed Location Countries Canada,   Czechia,   Hungary,   Russian Federation,   Spain,   Ukraine,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number NCT01146990
Other Study ID Numbers 17P-FU-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AMAG Pharmaceuticals, Inc.
Study Sponsor AMAG Pharmaceuticals, Inc.
Collaborators Registrat-Mapi
Investigators Not Provided
PRS Account AMAG Pharmaceuticals, Inc.
Verification Date July 2020