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Study on Antibiotic Levels in Blood of Pregnant Women with Twins Using Piperacillin, Tazobactam, Cefazolin, Ampicillin Sodium, and Clindamycin

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 focuses on understanding how antibiotics work in women who are pregnant with twins. The study involves several antibiotics, including piperacillin, tazobactam, cefazolin, ampicillin sodium, and clindamycin. These medications are commonly used to treat infections and will be given through a vein, known as intravenous use. The purpose of the study is to determine the concentration of these antibiotics in the blood of the mother and the newborns, specifically looking at any differences between the twin siblings.

Participants in the study will be women with twin pregnancies who are having a cesarean section, which is a surgical procedure to deliver the babies. The study will measure the levels of antibiotics in the mother's blood and the blood from the umbilical cord, which connects the mother to the babies. This will help researchers understand how the antibiotics are distributed in the body and how they might affect the twins differently. The study will also look at the safety and any side effects of the antibiotics used.

The trial aims to provide valuable information about the use of antibiotics during twin pregnancies, which can help improve treatment and care for both mothers and their babies. By studying the differences in antibiotic levels between the twins, researchers hope to gain insights into how these medications work in such unique pregnancies. The study is expected to continue until 2025, gathering data to ensure the safety and effectiveness of these treatments.

The research process

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

  1. Step 1

    Enrollment

    Upon joining the study, you will be asked to confirm your eligibility. This includes being a woman with a twin pregnancy, planning a c-section delivery between 24-42 weeks of gestation, and being between 18-55 years old.

    You will need to sign a consent form to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to gather baseline information. This may include a review of your medical history and current health status.

  3. Step 3

    Medication administration

    You will receive one or more of the following antibiotics through intravenous use:

    Piperacillin/Tazobactam: 4.0 g/0.5 g

    Cefazolin: 2 g

    Ampicillin sodium: 2 g

    Clindamycin: 600 mg/4 ml

    The dosage and frequency will be determined by the study protocol and your healthcare provider.

  4. Step 4

    Blood sample collection

    Blood samples will be collected from you to measure the concentration of antibiotics in your blood.

    After delivery, blood samples will also be taken from the umbilical cord to measure antibiotic levels in the newborns.

  5. Step 5

    Monitoring and follow-up

    You will be monitored for any side effects or adverse reactions to the antibiotics.

    Follow-up assessments will be conducted to check for any maternal postoperative infections or early-onset neonatal sepsis.

  6. Step 6

    Completion

    The study is expected to end by October 1, 2025. Your participation will conclude after all necessary data has been collected and analyzed.

Who can join the trial?

4 criteria

  • Women with twin pregnancies and delivery through c-section (surgical delivery) between 24-42 weeks of pregnancy.
  • Receiving one or more of the included antibiotic agents (medications used to treat infections).
  • Able and willing to sign the consent (agreement to participate in the study).
  • Ages 18-55 years old.

Who cannot join the trial?

1 criterion

  • Being currently **pregnant**.
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Investigated drugs

Antibiotic: This medication is used to fight bacterial infections. In this clinical trial, the antibiotic is being studied to understand how it moves through the body of pregnant women who are expecting twins. The researchers want to see how much of the antibiotic is present in the mother's blood and in the blood of the newborns, which is collected from the umbilical cord. They are also interested in finding out if there is any difference in the amount of antibiotic between the two twin siblings. This information can help doctors understand how to better use antibiotics in pregnant women with twins to ensure both the mother and babies are effectively treated.

What is already known about the treatment

Antibiotic – This medication is administered to pregnant women, specifically those with twin pregnancies, to study its concentration in both the mother's blood and the newborns' blood from the umbilical cord. The current status of this antibiotic in medical literature is under investigation, focusing on its pharmacokinetics during pregnancy. The main therapeutic indication is to understand how the drug is distributed and metabolized in the body during twin pregnancies. At the molecular level, antibiotics typically work by targeting and killing bacteria or inhibiting their growth, although the specific mechanism can vary depending on the type of antibiotic. This medication falls under the pharmacological classification of antibiotics, which are used to treat bacterial infections.

Investigated diseases

  • Maternal Postoperative Infection

    This condition occurs when an infection develops in a mother following a surgical procedure, such as a cesarean section. It typically begins with localized symptoms at the surgical site, such as redness, swelling, and pain. If not managed, the infection can spread, leading to systemic symptoms like fever and malaise. The progression of the infection can vary depending on the type of bacteria involved and the individual's immune response. In some cases, the infection may remain localized, while in others, it can lead to more widespread issues. Monitoring and early detection are crucial to managing the condition effectively.

  • Sepsis

    Sepsis is a severe and potentially life-threatening condition that arises when the body's response to infection causes injury to its own tissues and organs. It begins with an infection that can be localized anywhere in the body, such as the lungs, urinary tract, or skin. As the condition progresses, it can lead to widespread inflammation, known as systemic inflammatory response syndrome (SIRS). This can result in a cascade of changes that damage multiple organ systems, leading to organ dysfunction. The progression of sepsis can be rapid, requiring prompt medical attention to prevent further complications. Early recognition and intervention are key to managing the condition effectively.

  • Early-Onset Neonatal Sepsis

    This condition occurs in newborns, typically within the first 72 hours of life, and is caused by a bacterial infection acquired before or during birth. It often begins with subtle signs such as poor feeding, lethargy, or respiratory distress. As the infection progresses, it can lead to more severe symptoms, including temperature instability, apnea, and cardiovascular instability. The progression can be rapid, and the condition requires immediate medical attention to prevent further complications. Early detection and management are crucial to improving outcomes for affected newborns.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518564-12-00Estimated enrolment92 patientsSponsorMedical University Of Vienna

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