Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Clindamycin pharmacokinetics during obstetric or fetal surgery

This study is about understanding how an antibiotic called Clindamycin moves through the body of pregnant women, especially during pregnancy or foetal surgery (surgery on the baby before birth). The main goal is to find out the best way to give this medicine to prevent infections, making sure it's safe and effective for both the mother and baby. Researchers will measure the levels of Clindamycin in the mother's blood and in the fluid around the baby. They will compare this new information with what we already know about how the drug works in other adults and pregnant women. This helps doctors figure out the most appropriate dose for pregnant patients in the UK.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

UZ Leuven

Enrolment target

Start

30 Aug 2023

Prophylaxis (antibiotics) during maternal or fetal surgery

What is this study about?

This study is designed to understand how a common antibiotic called Clindamycin gets absorbed, used, and cleared by the body of pregnant women, especially when they need surgery, either for themselves or their baby, during pregnancy. When someone is pregnant, their body changes a lot, which can affect how medicines work. What might be the right dose for someone who isn't pregnant might be different for an expectant mother.

The main aim of this research is to figure out the best way to give Clindamycin to pregnant women to prevent infections during surgery. This medicine is often used to stop infections from starting after operations. By studying how the drug moves through the mother's body and into the fluid surrounding the baby, doctors can learn more about finding the safest and most effective dose for both.

Researchers will carefully measure the levels of Clindamycin in the mother’s blood and in the fluid that protects the baby. They will then compare this information with what we already know about how the drug works in other adults and pregnant women. This detailed analysis helps ensure that future mothers and babies receive the correct amount of medicine, which is crucial for preventing serious infections while keeping everyone safe.

Key takeaways

Studies how antibiotic Clindamycin works in pregnant women.
Aims to find the best dose for preventing surgical infections.
Measures medicine levels in mother's blood and baby's fluid.
Helps improve safety for pregnant mothers and their babies.
Participation involves receiving antibiotics and sample collection.
Your medical care is unaffected if you choose not to participate.

Who may be eligible?

This study is looking for women who are at least 18 years old and are pregnant. There isn't an upper age limit, meaning women of any age above 18 can be considered if pregnant.

The study focuses specifically on women, as it concerns pregnancy and foetal surgery.

Essentially, if you are an adult woman who is pregnant and might need surgery for yourself or your baby, you could potentially be eligible for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently pregnant?
Are you a woman?
Are you scheduled for maternal or fetal surgery?

Answer every question to see your result.

What does participation involve?

We don’t have all the details on what taking part involves, but typically, if you join this study, you would receive the antibiotic Clindamycin (a solution given by injection) as part of your surgical care. The important part of the study is that doctors will carefully collect blood samples from you and possibly samples of the fluid around your baby at different times. This is to measure how much of the medicine is in your body and how it's clearing out. These samples would usually be taken during your hospital stay for surgery. The total duration of your participation would depend on your hospital stay and the timing of these sample collections, but it’s usually for a short period around the time of your surgery.

Potential risks and benefits

Taking part could help doctors understand how to give antibiotics more effectively to pregnant women, potentially improving care for future mothers and babies. While Clindamycin is a commonly used antibiotic, there are always potential risks with any medicine, such as side effects like stomach upset, allergic reactions, or changes to gut bacteria. The risks related to taking extra blood samples or fluid samples are usually minimal, such as slight bruising or discomfort. You are completely free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is Clindamycin?

Clindamycin is an antibiotic medicine used to treat and prevent various bacterial infections, often given before or during surgery.

Why is this study important for pregnant women?

Pregnancy changes how medicines work in the body. This study helps doctors understand the best and safest dose of Clindamycin for pregnant women and their babies during surgery, to prevent infections.

Will my baby be affected by taking part?

The study aims to find the safest way to use Clindamycin for both mother and baby. Researchers will measure drug levels in the fluid around the baby to understand any potential exposure, always with safety as the top priority.

Do I have to take part if asked?

No, taking part in any research study is completely voluntary. Your decision will not affect the medical care you receive.

What kind of surgery is this study for?

This study is for pregnant women undergoing surgery, either for themselves (maternal surgery) or for their baby while still in the womb (fetal surgery).