Study on Betamethasone Sodium Phosphate and Drug Combination for Pregnant Women with Preterm Premature Rupture of Membranes

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What is this study about?

This clinical trial is focused on a condition known as preterm premature rupture of membranes (pPROM) in pregnancy. This condition occurs when the amniotic sac, which holds the baby and amniotic fluid, breaks earlier than expected, specifically before 37 weeks of pregnancy. The study aims to explore a personalized treatment approach to safely prolong pregnancy, improve outcomes for both the mother and the newborn, and reduce unnecessary use of antibiotics.

The trial will evaluate the effectiveness of a tailored treatment plan that includes specific antibiotics and steroids. The antibiotics being studied include gentamicin, benzylpenicillin, demeclocycline hydrochloride, and ampicillin combined with a beta-lactamase inhibitor. The steroid used in the study is dexamethasone. Additionally, magnesium sulfate is included for its neuroprotective properties. The treatment plan is based on the levels of a substance called IL-6 in the amniotic fluid, which is obtained through a procedure known as amniocentesis. This approach is compared to the standard treatment to see if it can help extend the pregnancy duration.

Participants in the study will receive either the tailored treatment or a standard treatment, which may include a placebo. The study will monitor how long the pregnancy lasts after the membranes rupture, as well as any short-term health effects on the mother and baby. The goal is to determine if the personalized treatment can effectively prolong pregnancy and improve health outcomes. The study will also look at the presence of certain infections and the microbiome, which is the collection of microorganisms in the body, in both the mother and the newborn.

1 joining the study

Upon joining the study, you will be asked to sign a consent form. This form confirms your understanding and agreement to participate in the trial.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, pregnancy weeks, and the condition of preterm premature rupture of membranes (pPROM).

3 amniocentesis procedure

A procedure called amniocentesis will be performed to collect a small sample of amniotic fluid. This is done to measure the level of a substance called IL-6, which helps tailor your treatment.

4 treatment plan

Based on the IL-6 value, a personalized treatment plan will be created. This may include antibiotics and steroids to help prolong your pregnancy and improve outcomes for you and your baby.

5 medication administration

You may receive medications such as dexamethasone and gentamicin through injections or infusions. The specific medications, dosage, and frequency will be determined by your treatment plan.

6 monitoring and follow-up

Regular monitoring will be conducted to track your health and the progress of your pregnancy. This includes checking for any signs of infection or other complications.

7 completion of the trial

The trial will conclude after the birth of your baby. The primary goal is to achieve a latency period of more than 7 days from the rupture of membranes to delivery.

Who Can Join the Study?

Must be 18 years or older.
Must have a condition called preterm premature rupture of membranes (pPROM), confirmed by a test called Amnisure or by a doctor’s examination. This means the water around the baby breaks earlier than expected.
Must be between 22 weeks and 33 weeks and 6 days of pregnancy.
Must be pregnant with one baby (not twins or more).
Must have signed a consent form agreeing to participate in the study.
Must have had a completely uncomplicated pregnancy until the occurrence of pPROM.

Who Cannot Join the Study?

Patients who are not pregnant cannot participate.
Men cannot participate in the study.
Patients who do not have a condition called preterm premature rupture of membranes cannot participate. This is when the water breaks early in pregnancy.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those who cannot give consent, are not included.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Fakultni Nemocnice Brno	Brno	Czechia
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
The Institute For The Care Of Mother And Child	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.03.2025

Trial locations

Investigated drugs:

Antibiotic Therapy is used in this trial to help prevent or treat infections in patients who have experienced a premature rupture of membranes during pregnancy. The goal is to reduce the risk of infection for both the mother and the baby, which can be a concern when the protective amniotic sac breaks early. By using antibiotics, the trial aims to prolong the pregnancy safely and improve outcomes for both the mother and the newborn.

Steroid Therapy is another treatment used in this trial. Steroids are given to help the baby’s lungs mature more quickly if there is a risk of preterm birth. This is important because the lungs are one of the last organs to fully develop in a baby. By speeding up lung development, steroids can help reduce the risk of breathing problems in the newborn if they are born prematurely. The trial is investigating whether using steroids based on specific test results can improve outcomes for both the mother and the baby.

Investigated diseases:

Preterm premature rupture of membranes

Preterm Premature Rupture of Membranes – This condition occurs when the amniotic sac breaks before 37 weeks of pregnancy and before the onset of labor. It leads to the leakage of amniotic fluid, which can increase the risk of infection for both the mother and the baby. The rupture can result in complications such as chorioamnionitis, an infection of the amniotic fluid and membranes, and funisitis, an inflammation of the umbilical cord. The progression of this condition can lead to preterm birth, which may affect the baby’s development and health. The time between the rupture and delivery is referred to as the latency period, which can vary in length. Monitoring and management are crucial to minimize risks and prolong pregnancy when possible.

Trial ID:

2024-520237-77-00

Protocol code:

TAILORED-PROM

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Betamethasone Sodium Phosphate and Drug Combination for Pregnant Women with Preterm Premature Rupture of Membranes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?