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NCT Number: NCT06325007

Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous

The goal of this randomized controlled trial is to examine the efficacy of combining castor oil ingestion with extra-amniotic single balloon catheter for cervical ripening on time from induction to delivery in nulliparous women.

The main question it aims to answer are:

Does the addition of the use of castor oil to extra-amniotic single balloon reduce the time until birth? Does the addition of the castor oil affect other perinatal outcomes during childbirth? Are the side effects of the castor tolerated by the mothers? Participants will be randomly divided into 2 groups: the study group will drink a mixture of 60 ml of castor oil mixed with 140 ml of orange juice. Thirty minutes later, an extra-amniotic single balloon catheter will be inserted above the internal cervical os and filled with 60 mL of normal saline. In the control group, a foley catheter will be inserted into cervical canal without ingestion of castor oil.

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Key information

Conditions

Induction of Labor Affected Fetus / Newborn

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Holy Family Hospital, Nazareth, Israel

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About this study

The rate of labor induction has increased up to 25.7% in 2018 for several demographic and obstetric reasons. In nulliparous women the reported rate is nearly 32%.

Various methods are used to induce labor worldwide, including natural, mechanical and pharmacological agents. of all methods balloon catheters were proven to cause fewer adverse perinatal events.

Though induction is considered a safe and effective procedure, it may lead to a prolonged labor which is associated with complications such postpartum hemorrhage, infection, and operative delivery.

Based on these data several studies have examined the combinations of balloon catheters with other pharmacological agents on labor durations. The results were inconsistent, and several reports showed that the combination reduced significantly the length of labor. Nevertheless, pharmacological agents may be associated with adverse events including uterine hyperstimulation, placental abruption, and postpartum hemorrhage, though the overall risk is small.

Castor oil, extracted from the seeds of Ricinus communis plant, is a natural effective substance for induction of labor. it's considered a safe and inexpensive though the exact mechanism by which it induces labor is still unclear.

Our hypothesis suggests that ingestion of castor oil combined with the balloon catheter will shorten the time to delivery. In order to show a reduction by 3 hours, a sample size of 57 in each group will be needed assuming 80% power and a two-tailed alpha of 5%.

Since the success rate of vaginal delivery is nearly 85%, the sample size was calculated to 67 women in each group. Additional 5% are planned to be recruited to account for trial drop out for any reason, yielding a total final sample size of 71 women in each group (142 in both groups).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women above 18 years old
  • Sign an informed consent
  • Term pregnancy (>37 weeks)
  • Viable fetus
  • Singleton
  • Vertex presentation
  • Intact membranes
  • Cervix with Bishop score ≤6

Exclusion criteria

  • Previous cesarean delivery
  • Major fetal malformations
  • Contraindication to spontaneous vaginal delivery
  • Amniotic fluid index >25cm
  • Chorioamnionitis at admission
  • Placental abruption
  • Previous prostaglandin use for induction of labor
  • A low-lying placenta (up to 2 cm from the internal os)
  • Carriers of hepatitis B or C or human immunodeficiency viruses
  • Women with a history of allergy to latex.
  • Women with a history of allergy to castor oil

Treatment and study plan

Induction of labor

Dietary Supplement

The study group only will drink a mixture of 60 ml of castor oil mixed with 140 ml of orange juice. Thirty minutes later, in both groups, an extraamniotic single balloon catheter will be inserted above the internal cervical os and filled with 60 mL of normal saline. Following removal, artificial rupture of the membranes will be performed as long as it is safe with regards to fetal head position. Oxytocin infusion will be commenced at once if contraction has not begun spontaneously (2 to 3 regular uterine contractions per 10 minutes). Continuous electronic fetal monitoring will be used throughout labor. Labor will be managed by the attending obstetricians and midwives. Labor progress abnormalities will be diagnosed and managed according to the department protocol based on the recommendations of the American College of Obstetricians and Gynecologists.

Primary outcomes

  1. time to delivery

    Time frame: 48 hours

    Time from catheter insertion to vaginal delivery.

Secondary outcomes

  1. balloon expulsion time

    Time frame: 12 hours after insertion

    The time until balloon was spontaneously expelled

  2. Bishop score after catheter expulsion

    Time frame: 12 hours

    Bishop score after removal of the catheter where a high score (above 7) indicates a better outcome.

  3. Fetal presentation at the delivery

    Time frame: 48 hours

    The insertion of a balloon may lead to a change in the presenting part of the fetus. A change to a non-vertex presentation is carried as an undesired outcome.

  4. Duration of the active phase of labor

    Time frame: 4 hours

    Duration of the time from 6 cm cervical dilatation to 10 cm cervical dilatation

  5. Duration of second stage

    Time frame: 4 hours

    the time from 10 cm cervical dilatation until the delivery of the baby

  6. Mode of delivery

    Time frame: 48 hours

    Whether the birth was a normal spontaneous birth, operative vaginal birth or a cesarean section.

  7. Indications for cesarean or operative vaginal deliveries

    Time frame: 48 hours

    Was the reason for operative vaginal delivery or cesarean delivery due to non progress labor, fetal status, or a combination of both?

  8. Intrapartum fever

    Time frame: 48 hours

    Number of patients that will have intrapartum fever ≥ 38 °C

  9. Number of patients that will require use of intrapartum use of antibiotic treatment.

    Time frame: 48 hours

    Number of patients that will require use of intrapartum use of antibiotic treatment due to intrapartum infection.

  10. Number of Participants with that will develop clinical signs of chorioamnionitis.

    Time frame: 48 hours

    Clinical signs of chorioamnionitis includes abdominal tenderness, abnormal discharge, intrapartum fever, tachycardia

  11. Number of Participants with that will develop 3rd and 4th degrees perineal lacerations.

    Time frame: 48 hours

    Obstetric anal sphincter injury

  12. Number of Participants with develop postpartrum hemorrhage.

    Time frame: 48 hours

    early postpartum hemorrhage (PPH)

  13. Number of Participants with need blood transfusion.

    Time frame: 72 hours

    PPH that required blood transfusion

  14. Side effects related to castor oil use

    Time frame: 48 hours

    nausea, vomiting, uterine hyperstimulation> the 5 contractions: 10 minutes

  15. Oxytocin maximal dosage

    Time frame: 48 hours

    Oxytocin maximal dosage

  16. Number of participants with Umbilical Cord prolapse.

    Time frame: 48 hours

    Umbilical cord prolapse is when the umbilical cord exits the cervical os before the fetal presenting part that may result in fetal hypoxia.

  17. Apgar score (0 to 10).

    Time frame: 48 hours

    APGAR< 7 after 1 and 5 minutes where lower scores mean a worse outcome.

  18. pH taken from umbilical artery

    Time frame: 48 hours

    Cord artery pH <7.1

  19. Neonatal birthweight

    Time frame: 48 hours

    Neonatal birthweight

  20. Number of neonates with Neonatal fever ≥ 38 °C

    Time frame: 72 hours

    Neonatal fever >38

  21. The number of neonates that will develop neonatal sepsis.

    Time frame: 72 hours

    Diagnosis of neonatal sepsis based on clinical signs of sepsis and positive cultures.

  22. The number of neonates that will require antibiotic treatment.

    Time frame: 72 hours

    Need for antibiotic treatment

  23. Neonatal complications

    Time frame: 48 hours

    respiratory distress syndrome, transient tachypnea of newborn, intracranial hemorrhage, intraventricular hemorrhage, seizures, Meconium aspiration syndrome ,Hypoxic ischemic encephalopathy

  24. The number of neonates that will Admit to neonatal intensive care unit (NICU)

    Time frame: 30 days

    Neonatal admission to NICU

  25. Length of stay in NICU.

    Time frame: 30 days

    Neonatal length of stay in NICU.

  26. neonatal death

    Time frame: 30 days

    neonatal death

  27. Maternal hemoglobin level after delivery.

    Time frame: 48 hours

    higher level of Hemoglobin and indicate better outcome.

  28. Number of participants that will require postpartum hysterectomy.

    Time frame: 72 hours following delivery.

    Maternal hysterectomy

  29. Number of participants that will require postpartum laparotomy.

    Time frame: 72 hours following delivery.

    Number of participants that will require postpartum laparotomy after vaginal delivery or re-laparotomy after cesarean section.

  30. postpartum maternal complications

    Time frame: 72 hours following the delivery.

    endometritis

  31. The length of stay from birth to discharge home.

    Time frame: up to 10 days

    The length of stay in days from birth to discharge home.

  32. Maternal satisfaction from delivery process.

    Time frame: up to 10 days after delivery

    1 = Very dissatisfied, 10 = Very satisfied

Study contacts

Contact information is provided by the study sponsor or research team.

Raed Salim, MD

CONTACT

[email protected]

+972544986960

wiaam khatib, MD

CONTACT

[email protected]

+972549192433

Sponsors and collaborators

Lead sponsor

Holy Family Hospital, Nazareth, Israel

Other

Registry information

Official study title

The Effect of Combining Single Balloon Catheter With Castor Oil Ingestion for Cervical Ripening on Time to Delivery Among Nulliparous Women.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 22, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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