Clindamycin pharmacokinetics during obstetric or fetal surgery - S-67465

Z Leuven0 个研究点目标入组 0 人开始时间: 2023年6月5日最近更新: 2024年7月22日

适应症

试验速览

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•1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures, 2. Singleton and twin pregnancy that fulfill criteria for fetal and obstetric interventions in the second and third trimester of pregnancy, 3. Admitted and hospitalized at the obstetrics surgery ward, 4. Monochorionic twin pregnancy identified to have twin-twin transfusion syndrome (TTTS) or selective fetal growth restriction (sFGR) requiring fetoscopic laser surgery (FLS), 5. Singleton pregnancy undergoing fetal interventions or surgery for example for Congenital Diaphragmatic Hernia (CDH) or Myelomeningocele (MMC), 6. Planned (prescribed) IV dosing of clindamycin as prophylaxis before surgery.

•1. Participant has pre-existing type I diabetes, 2. Any disorder, which in the Investigator's opinion might jeopardize the participant's safety or compliance with the protocol, 3. Any prior or concomitant treatment(s) that might jeopardize the participant's safety or that would compromise the integrity of the Trial, 4. Participation in an interventional Trial with an investigational medicinal product (IMP) or device, 5. Contraindication for clindamycin (non-limitative: hypersensitivity,...), 6. Treatment with CYP450 inductor within 14 days before clindamycin initiation (e.g., carbamazepine, efavirenz).

发起方

Z Leuven