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Clindamycin pharmacokinetics during obstetric or fetal surgery
EU CTIS ID: 2023-503653-35-00
What this study is testing
The primary aim is to describe the pharmacokinetics of clindamycin and its metabolites during pregnancy, in the relevant compartments (maternal plasma, amniotic fluid) during and following obstetric or fetal surgery by performing a population pharmacokinetics analysis approach.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.