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Antibiotic Treatment with Clindamycin and Benzylpenicillin to Prevent Group G and C Streptococcal Infections in Pregnant Women

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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 preventing infections caused by Group G and C Streptococcus during childbirth. These bacteria can be part of the natural flora found in the vaginal and rectal areas of some pregnant women. The study aims to evaluate the effectiveness of giving antibiotics during labor to prevent infections in both the mother and the newborn. The antibiotics being studied are Clindamycin and Benzylpenicillin, which are administered through an injection or infusion.

Participants in this study are pregnant women who have been found to carry Group G or C Streptococcus in their vaginal-rectal area during routine screening in late pregnancy. The study will compare the effects of the antibiotics with a placebo to determine their effectiveness in preventing infections. The main goal is to see if these antibiotics can reduce the risk of postpartum infections in mothers and any related complications in newborns.

The study will follow participants from the time of labor through the postpartum period, which is the time after childbirth. Researchers will monitor for any infections in the mother that require antibiotic treatment up to three months after delivery. They will also observe the health of the newborn, including any need for additional medical care. The study is expected to provide valuable information on the best ways to prevent infections during and after childbirth.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after confirmation of carrying Group G or C Streptococcus in the vaginal-rectal flora. This is determined by a culture taken between 35 and 38 weeks of pregnancy.
Step 2
Administration of antibiotics during labor
During labor, antibiotics are administered intravenously to prevent infections. The medications used are Clindamycin and Benzylpenicillin, both provided as solutions for injection or infusion.
The specific dosage and frequency of administration are determined by the healthcare provider based on individual needs.
Step 3
Monitoring after childbirth
After delivery, monitoring occurs to check for any signs of infection in the mother. This includes observing for symptoms that may require further antibiotic treatment up to three months postpartum.
Step 4
Evaluation of newborn health
The newborn's health is assessed, including the need for blood cultures or antibiotic treatment. The possibility of transfer to the neonatal intensive care unit (NICU) is evaluated if necessary.
Step 5
Hospital stay
The duration of the hospital stay for both the mother and the newborn is recorded. This includes the length of stay after birth or delivery.

Who can join the trial?

4 criteria

The study is for pregnant women.
Participants must be between 35 and 38 weeks of pregnancy.
Participants must have a test showing they carry Group G or C Streptococcus in their vaginal-rectal area. This test is usually done to check for another type of bacteria called GBS.
Only women can participate in this study.

Who cannot join the trial?

5 criteria

Women who are not pregnant cannot participate.
Women who do not have Group G or C Streptococcus bacteria in their vaginal-rectal area cannot participate. This is checked during a routine test for another type of bacteria called GBS.
Women who are not in the late stages of pregnancy cannot participate.
Men cannot participate in this study.
People who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups that might need special protection or care.

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Pirkanmaan hyvinvointialue
Tampere, Finland

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Investigated drugs

Antibiotic Prophylaxis is used in this trial to prevent infections caused by Group G/C Streptococcus bacteria during labor and after childbirth. The antibiotics are given to the mother during labor to reduce the risk of infection for both the mother and the newborn. This approach aims to protect against potential complications that can arise from these bacterial infections.

What is already known about the treatment

Antibiotic Prophylaxis – This medication is administered intravenously during labor to pregnant women who carry Group G or C Streptococcus in their vaginal-rectal flora. It is currently being studied in clinical trials to assess its effectiveness in preventing infections caused by these bacteria in both mothers and newborns during and after childbirth. The main therapeutic indication is to prevent Group G/C Streptococcus infections. The mechanism of action involves inhibiting bacterial cell wall synthesis, leading to the destruction of the bacteria. It is classified as an antibiotic, specifically targeting bacterial infections.

Investigated diseases

Group G Streptococcus Infection
This infection is caused by Group G Streptococcus bacteria, which can be part of the normal flora in the human body but may lead to infections under certain conditions. In pregnant women, these bacteria can be found in the vaginal-rectal area and may pose a risk during childbirth. The infection can progress to cause postpartum complications in the mother, such as fever and inflammation, requiring medical attention. It can also affect the newborn, potentially leading to serious health issues if not managed properly. The bacteria can spread through direct contact during delivery, making it important to monitor and manage the condition to prevent transmission.
Group C Streptococcus Infection
This infection is caused by Group C Streptococcus bacteria, which are similar to Group G in that they can be part of the normal flora but may cause disease under certain circumstances. In pregnant women, these bacteria can be present in the vaginal-rectal area and may lead to complications during and after childbirth. The infection can result in postpartum issues for the mother, such as fever and inflammation, which may require antibiotic treatment. It can also pose a risk to the newborn, potentially leading to infections if not properly addressed. The bacteria can be transmitted during delivery, necessitating careful monitoring and management to prevent complications.