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Comparison of Oxytocin versus Prostaglandins (Dinoprostone and Misoprostol) for Labor Induction in Women with Unfavorable Cervix After Initial Cervical Ripening

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 study focuses on labor induction in pregnant women who have an unfavorable cervix after initial cervical ripening treatment. The research compares two different approaches to inducing labor: using oxytocin versus continuing with prostaglandins. The purpose is to determine if using oxytocin is as effective as prostaglandins for labor induction after the first 24 hours of cervical preparation.

The medications being studied include Oxytocine Panpharma, which is given through an intravenous injection, and several prostaglandin preparations: Propess (vaginal delivery system), Prostine E2 (vaginal gel), and Angusta (oral tablet). These medications are commonly used to help start and progress labor in pregnant women whose cervix is not yet ready for delivery.

During the study, women will receive either oxytocin through an IV or one of the prostaglandin medications after their initial cervical ripening treatment has been completed. The study will track various outcomes related to the delivery process and the health of both mother and baby, with special attention to the rate of cesarean delivery. The research will also evaluate factors such as the time until delivery and any complications that may occur during the process.

The research process

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

  1. Step 1

    Initial assessment

    After 24 hours of initial cervical ripening, your cervix condition will be evaluated using the Bishop score (a method to assess cervical readiness for labor).

    If the Bishop score is 6 or lower, indicating an unfavorable cervix, you may be eligible to continue with the next step.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive one of two treatment options:

    Option 1: Oxytocin administered through an intravenous line

    Option 2: Additional prostaglandins for cervical ripening, which may include one of the following:

    - Propess (vaginal delivery system)

    - Angusta (oral tablet)

    - Prostine E2 (vaginal gel)

  3. Step 3

    Labor monitoring

    Your labor progress will be monitored continuously.

    Medical staff will check for signs of:

    - Uterine contractions

    - Changes in cervical dilation

    - Your vital signs

    - Your baby's heart rate and position

  4. Step 4

    Delivery phase

    The delivery method will be determined based on your labor progress and medical circumstances.

    This may include:

    - Natural vaginal delivery

    - Assisted vaginal delivery with instruments if needed

    - Cesarean delivery if medically necessary

  5. Step 5

    Post-delivery monitoring

    After delivery, you and your baby will be monitored for any complications.

    The medical team will assess:

    - Your recovery progress

    - Any signs of bleeding

    - Your baby's health status

    The length of hospital stay will be determined based on your recovery and medical needs.

Who can join the trial?

9 criteria

  • Must be a pregnant woman
  • Must be 18 years or older
  • Must have a single pregnancy with the baby's head positioned downward (cephalic presentation)
  • Must be at least 37 weeks pregnant (full-term pregnancy)
  • Pregnancy duration must have been confirmed by an ultrasound performed between 11 and 13 weeks + 6 days of pregnancy
  • Must have undergone a previous attempt to prepare the cervix for labor (cervical ripening) for 24 hours
  • Must have an unfavorable cervix with a Bishop score of 6 or less (Bishop score is a measure of how ready the cervix is for labor)
  • Must be able to provide written informed consent to participate
  • Must have French health insurance coverage

Who cannot join the trial?

16 criteria

  • Previous cesarean section or other major surgery on the uterus
  • Multiple pregnancy (carrying more than one baby)
  • Non-head first presentation of the baby
  • Signs of fetal distress (when the baby shows signs of not tolerating labor well)
  • Known allergies to medications used for labor induction
  • Active genital herpes infection
  • Significant vaginal bleeding
  • Placenta previa (when the placenta covers the cervix)
  • Previous unsuccessful attempts at labor induction
  • Major medical conditions that could complicate labor (such as severe heart disease)
  • Abnormal fetal heart rate patterns
  • Evidence of serious pregnancy complications
  • Age under 18 years
  • Inability to provide informed consent
  • Current participation in other clinical trials
  • Contraindication to vaginal delivery
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Investigated drugs

  • Oxytocin

    is a hormone-based medication used to start or speed up labor contractions. It helps the uterus contract during childbirth. This medication is typically given through an IV (intravenous) line during labor induction.

  • Prostaglandins

    are medications used for cervical ripening, which means they help soften and prepare the cervix for labor. They can be applied directly to the cervix to make it more favorable for labor and delivery. These medications mimic natural substances in the body that help prepare for childbirth.

What is already known about the treatment

  • Oxytocin

    A naturally occurring hormone that is synthetically produced for medical use, administered intravenously for labor induction. This medication stimulates uterine contractions by binding to specific receptors in the uterine muscle tissue, making it a primary choice for inducing and augmenting labor in obstetric care. Oxytocin belongs to the class of peptide hormones and is widely recognized in medical literature as a standard medication for labor induction, particularly when cervical ripening has already occurred.

  • Prostaglandins

    A group of hormone-like substances administered vaginally or orally for cervical ripening and labor induction. These compounds work by softening and dilating the cervix while also stimulating uterine contractions, making them particularly effective for women with an unfavorable cervix. Prostaglandins are classified as hormone-like lipid compounds and are well-established in medical literature as effective agents for cervical preparation before labor, often used as an initial step in the labor induction process.

Investigated diseases

  • Labor Induction Condition

    A medical situation where labor needs to be artificially started in pregnant women who have an unfavorable cervix (not ready for delivery) even after 24 hours of initial cervical preparation. The cervix in this condition remains firm, long, and not adequately dilated, making natural labor difficult. This condition requires medical intervention to help prepare the cervix and initiate labor contractions. Women with this condition have completed their pregnancy term but their bodies haven't naturally started the labor process.

  • Uterine Hyperstimulation

    A condition where the uterus contracts too frequently, too strongly, or for too long during labor. These excessive contractions can occur naturally or as a result of labor-inducing medications. The contractions typically happen more than five times within a ten-minute period. This condition can affect the normal pattern of labor and may impact the oxygen supply to the baby.

  • Post-partum Hemorrhage

    Excessive bleeding after childbirth that occurs when the uterus fails to contract properly or when there are remaining fragments of placental tissue. The condition can develop immediately after delivery or up to 12 weeks postpartum. Blood loss exceeds the normal amount expected after delivery.

  • Meconium Aspiration Syndrome

    A breathing condition that occurs when a newborn inhales a mixture of meconium and amniotic fluid during or around the time of delivery. Meconium is the baby's first stool, which is normally passed after birth. The condition causes breathing difficulties and can affect the baby's oxygen levels.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517675-20-00Protocol codeDR200090Estimated enrolment1 494 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

sourced from the EU Clinical Trials Register and site verification

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