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Study Comparing Cook's Balloon and Dinoprostone for Inducing Labor in Pregnant Women with Fetal Growth Restriction at Term

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 studying a condition known as fetal growth restriction, which occurs when a baby does not grow as expected during pregnancy. The study is comparing two methods for inducing labor in pregnancies affected by this condition. One method uses a device called Cook's balloon, and the other uses a medication called dinoprostone, which is delivered through a vaginal system known as PROPESS 10 mg. The purpose of the study is to determine if using Cook's balloon increases the chances of a vaginal delivery without increasing health risks for the newborn, compared to using dinoprostone.

Participants in the study will be women who are at least 37 weeks pregnant with a single baby that is in the head-down position. The study will involve the use of either Cook's balloon or dinoprostone to help prepare the cervix for labor. The study will monitor the outcomes of these methods to see which one is more effective in achieving a vaginal delivery.

The trial will take place over a period of time, with participants being monitored throughout the process to ensure the safety and health of both the mother and the baby. The main goal is to find out which method is better for inducing labor in cases of fetal growth restriction, while keeping the risk of complications low for the newborn.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as being at least 18 years old, having a single pregnancy, and being at least 37 weeks pregnant.

    The pregnancy must be in cephalic presentation, and there should be no previous cesarean sections or contraindications for vaginal delivery.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the condition of the pregnancy, focusing on fetal growth restriction.

    The Bishop score, which assesses the readiness of the cervix for labor, is checked and should be less than 7.

  3. Step 3

    Treatment allocation

    Participants are allocated to one of two treatment groups: the Cook's balloon group or the dinoprostone group.

    The allocation determines the method used for inducing labor.

  4. Step 4

    Administration of dinoprostone

    If allocated to the dinoprostone group, a vaginal delivery system containing 10 mg of dinoprostone is used.

    The medication is administered vaginally to help ripen the cervix and induce labor.

  5. Step 5

    Monitoring and labor induction

    Continuous monitoring of the mother and fetus is conducted to ensure safety and effectiveness of the labor induction process.

    The progress of labor is closely observed, and adjustments to the treatment may be made based on the response.

  6. Step 6

    Completion of the trial

    The primary endpoint of the trial is achieving a vaginal delivery.

    The trial concludes with the delivery of the baby, and data is collected to assess the outcomes related to the method of labor induction used.

Who can join the trial?

9 criteria

  • Must be pregnant with only one baby.
  • Must be at least 18 years old.
  • Pregnancy must be at least 37 weeks along, confirmed by an ultrasound in the first trimester.
  • The baby must be in a head-down position, ready for birth.
  • Must have Stage I intrauterine growth restriction, which means the baby is smaller than expected. This is determined by either the baby's estimated weight being less than the 3rd percentile or less than the 10th percentile with additional signs like high blood flow resistance in the umbilical artery or low blood flow to the baby's brain.
  • Must have a Bishop score of less than 7. The Bishop score is a way to measure how ready the cervix is for labor.
  • The amniotic sac must be intact, meaning the water has not broken.
  • Must not have had a previous cesarean section.
  • There should be no medical reasons preventing a vaginal delivery or the induction of labor.

Who cannot join the trial?

10 criteria

  • Participants cannot have any other medical conditions that might interfere with the study.
  • Participants must not have any known allergies to the medications used in the study.
  • Participants should not have any complications during pregnancy that are not related to fetal growth restriction.
  • Participants must not have any history of previous uterine surgery, such as a cesarean section.
  • Participants should not have any infections that could affect the pregnancy or the study results.
  • Participants must not be part of another clinical trial at the same time.
  • Participants should not have any conditions that require immediate delivery of the baby.
  • Participants must not have any known issues with the placenta, such as placenta previa, where the placenta covers the cervix.
  • Participants should not have any severe health conditions that could pose a risk during the study.
  • Participants must not have any history of drug or alcohol abuse.
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Investigated drugs

  • Cook's Balloon

    is a medical device used for cervical ripening, which is a process to prepare the cervix for labor. It is a type of balloon catheter that is inserted into the cervix and then inflated. This helps to gently open and soften the cervix, making it easier for labor to start. In this trial, Cook's Balloon is being used to induce labor in pregnancies where the baby is not growing as expected.

  • Dinoprostone

    is a medication used to help induce labor by ripening the cervix. It is a synthetic form of a natural substance called prostaglandin, which helps to soften and dilate the cervix, preparing it for labor. In this study, dinoprostone is being compared to Cook's Balloon to see which method is more effective for inducing labor in pregnancies with fetal growth restriction.

What is already known about the treatment

  • Dinoprostone

    Dinoprostone is administered as a vaginal insert or gel to induce labor in pregnant women. It is currently well-established in medical practice and literature for its role in labor induction. The main therapeutic indication for dinoprostone is to ripen the cervix and induce labor in women at term or near term. At the molecular level, dinoprostone works by mimicking the natural prostaglandins in the body, which help to soften and dilate the cervix, facilitating labor. It is classified pharmacologically as a prostaglandin E2 analog.

  • Cook's Balloon

    Cook's Balloon is a mechanical device used for cervical ripening and labor induction, typically inserted into the cervix. It is recognized in medical literature as an alternative to pharmacological methods for inducing labor. The primary therapeutic indication is to aid in the induction of labor, particularly in cases of fetal growth restriction. Mechanistically, the balloon exerts pressure on the cervix, promoting dilation and effacement through mechanical means rather than chemical. It is classified as a mechanical cervical ripening device.

Investigated diseases

Fetal Growth Restriction – Fetal growth restriction is a condition where a fetus is unable to grow at the expected rate during pregnancy. This can result in the baby being smaller than normal for the gestational age. The condition can occur due to various factors, including problems with the placenta, maternal health issues, or genetic factors. As the pregnancy progresses, the restricted growth can lead to complications, such as reduced oxygen and nutrient supply to the fetus. Monitoring and management are crucial to ensure the health of both the mother and the baby.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513523-16-00Protocol codeCOLIGROWEstimated enrolment172 patientsSponsorHospital Universitario 12 De Octubre

sourced from the EU Clinical Trials Register and site verification

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