Last updated on June 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Premature | Obstetric Labour
  • Age: Between 1 - 1 Years
  • Gender: Male or Female

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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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