Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:11/17/2018
Start Date:June 1, 2015
End Date:July 29, 2022
Contact:US GSK Clinical Trials Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

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Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies

The primary objective of this study is to assess the safety and outcomes of infants and
children who were exposed to retosiban or comparator in utero in the planned Phase III
spontaneous preterm labor (SPTL) treatment studies, to provide assurance that treatment is
not associated with significant adverse outcomes in early childhood. The enrolled infants and
children will be followed at pre-specified intervals until they reach 5 years chronological
age. This study does not require medical interventions or study visits to an investigational
site, instead, parents or legal guardians will be prompted at certain time points to complete
developmental questionnaires and other data on their children's health status via an
electronic device. Data collected during the infant and child follow up study will be managed
by a centralized research coordinating center (RCC). Regionally based pediatricians will
serve as study principal investigators (referred to as RCC-PIs) for this study. All
communications the RCC-PI has with the parent/legal guardian or the child's health care
provider (HCP) will occur remotely; there will be no clinic visits.


Inclusion Criteria:

- Mother is randomly assigned and dosed (retosiban or comparator) in 1 of the Phase III
SPTL retosiban clinical studies.

- Infant is alive at 28 days post EDD.

- Written informed consent is obtained from the parent(s) or legal guardian(s) of the
infant. The parent/legal guardian of participants aged 12 to 17 years must also
provide written agreement for the infant to participate in the study where required by
applicable regulatory and country or state requirements.

Exclusion Criteria:

- There are no formal exclusion criteria for participation.
We found this trial at
16
sites
Louisville, Kentucky 40202
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Bethesda, Maryland 20892
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Bethesda, MD
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Birmingham, Alabama 35249
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Birmingham, AL
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Bruges,
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Bruges,
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Charleston, South Carolina 29425
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Charleston, SC
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Cleveland, Ohio 44195
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Cleveland, OH
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Durham, North Carolina 27705
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Durham, NC
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Galveston, Texas 77555
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Galveston, TX
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Jacksonville, Florida 32207
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Jacksonville, FL
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Maywood, Illinois 60153
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Maywood, IL
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Newark, New Jersey 07112
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Newark, NJ
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Park Ridge, Illinois 60068
Principal Investigator: Preetha Prazad
Phone: 877-379-3718
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Park Ridge, IL
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Portland, Oregon 97227
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Portland, OR
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Tacoma, Washington 98405
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Tacoma, WA
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