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Study on Clindamycin Use for Infection Prevention in Pregnant Women Undergoing Maternal or Fetal Surgery

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding how the antibiotic clindamycin behaves in the body during surgeries related to pregnancy, specifically during obstetric or fetal surgery. The study involves using Dalacin C 600 mg solution injectable, which contains the active ingredient clindamycin phosphate. This medication is administered intravenously, meaning it is given directly into a vein. The purpose of the study is to explore how clindamycin moves through the body and is processed during and after these types of surgeries.

The study will look at how clindamycin is distributed in different parts of the body, such as the mother's blood and the amniotic fluid, which surrounds the baby during pregnancy. This will help researchers understand how the drug works in pregnant women undergoing surgery. The study will involve collecting samples at various times to measure the levels of clindamycin in the body. This information will be compared to existing data from other adults and pregnant women to see if there are any differences.

Participants in the study will include women who are pregnant with one or two babies and are scheduled for certain types of fetal or obstetric surgeries. These surgeries might be necessary for conditions like twin-twin transfusion syndrome or congenital diaphragmatic hernia. The study will help determine the best way to use clindamycin as a preventive measure during these surgeries. By understanding how the drug is processed in the body, the study aims to improve the safety and effectiveness of clindamycin use in pregnant women undergoing surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, ensure that voluntary written informed consent is provided. This consent can be given by you or your legally authorized representative.
Participation is open to those with a singleton or twin pregnancy that meets the criteria for fetal and obstetric interventions in the second and third trimester of pregnancy.
Step 2
Hospital admission
Admittance to the obstetrics surgery ward is required. This is where the necessary medical procedures will take place.
For twin pregnancies, conditions such as twin-twin transfusion syndrome (TTTS) or selective fetal growth restriction (sFGR) may require fetoscopic laser surgery (FLS).
Step 3
Pre-surgery preparation
For singleton pregnancies, fetal interventions or surgeries may be planned for conditions like congenital diaphragmatic hernia (CDH) or myelomeningocele (MMC).
Before surgery, an intravenous (IV) dose of clindamycin is prescribed as a preventive measure against infection.
Step 4
Medication administration
The medication used is Dalacin C 600 mg solution injectable, which contains clindamycin phosphate.
This medication is administered intravenously, meaning it is given directly into a vein.
Step 5
Sample collection
During and after the surgery, samples will be collected to measure clindamycin concentrations in maternal plasma and amniotic fluid.
These samples help in understanding how the medication is processed in the body during pregnancy.
Step 6
Data analysis
A population pharmacokinetic analysis will be performed. This involves comparing the collected data with existing data from other adults or pregnant women.
The analysis will consider various factors such as body weight, age, and any other medications being taken.

Who can join the trial?

6 criteria

The participant or their legally authorized representative must provide voluntary written informed consent before any screening procedures.
The participant must have a **singleton** (one baby) or **twin pregnancy** (two babies) that meets the criteria for fetal and obstetric interventions in the second and third trimester of pregnancy.
The participant must be admitted and hospitalized at the obstetrics surgery ward.
If the participant has a **monochorionic twin pregnancy** (twins sharing one placenta), it must be identified to have **twin-twin transfusion syndrome (TTTS)** or **selective fetal growth restriction (sFGR)** requiring **fetoscopic laser surgery (FLS)**.
If the participant has a **singleton pregnancy**, they must be undergoing fetal interventions or surgery, for example, for **Congenital Diaphragmatic Hernia (CDH)** or **Myelomeningocele (MMC)**.
The participant must have a planned (prescribed) **IV dosing of clindamycin** as a preventive measure before surgery.

Who cannot join the trial?

5 criteria

Patients who are not pregnant cannot participate.
Patients who are male cannot participate.
Patients who are not undergoing maternal or fetal surgery cannot participate.
Patients who are not receiving **antibiotics** (medicines that fight infections) during surgery cannot participate.
Patients who are not part of a vulnerable population cannot participate.

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Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

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Investigated drugs

Clindamycin is an antibiotic used to treat various bacterial infections. In this clinical trial, it is being studied to understand how it moves through the body during pregnancy, especially when surgery is involved. Researchers are looking at how clindamycin and its breakdown products are present in the mother's blood and the amniotic fluid, which surrounds the baby. This information helps doctors know how the medication behaves in pregnant women undergoing surgery, ensuring it is safe and effective for both the mother and the baby.

Clindamycin Phosphate

What is already known about the treatment

Clindamycin – Clindamycin is administered orally or intravenously, depending on the specific medical needs. It is currently being studied for its effectiveness and behavior in the body during pregnancy, particularly in the context of maternal or fetal surgery. The main use of clindamycin in this setting is to prevent infections by acting as an antibiotic. At the molecular level, clindamycin works by inhibiting bacterial protein synthesis, which stops bacteria from growing and multiplying. It is classified as a lincosamide antibiotic, which is a type of medication used to treat bacterial infections.

Investigated diseases

Prophylaxis during maternal or fetal surgery – This is a preventive measure used to reduce the risk of infection during surgical procedures involving the mother or fetus. It involves the administration of antibiotics to prevent potential bacterial infections that could occur during or after surgery. The process is crucial in maintaining the health of both the mother and the fetus by minimizing the risk of complications associated with infections. The progression involves monitoring the effectiveness of the antibiotics in preventing infections throughout the surgical process. The focus is on ensuring that the antibiotics reach the necessary compartments, such as maternal plasma and amniotic fluid, to provide adequate protection. This preventive approach is tailored to the specific needs of the surgical procedure and the individual characteristics of the patient.