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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Saint Joseph Marseille France
Hopital NOVO Pontoise France
Hopital Beaujon Clichy France
Capxld Hzkoocmpxic Ruuafpgc Dwqnrbqbqvtszf Angers France
Cfcupc Hugcexxkngd Rgdtcmgq Upsmuhhcimsge Dp Ttjfa Tours France
Cchg Dg Nqcml Vandoeuvre Les Nancy France
Ipvaatbf dz Cpeuakwvhazh Hkgwjnngmok Ukryvhqosiqvv dx Sical Eagnkab (oarpyvx Saint Priest En Jarez France
Hmeyydmy Uroczjhesrogow Smvjlzcuuv &gdfwxm Htkzkvw dq Hsudvfvcnei STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
28.09.2021

Trial locations

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.

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 ID:
2024-517675-20-00
Protocol code:
DR200090
NCT ID:
NCT04949633
Trial Phase:
Human Pharmacology (Phase I) – Other

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