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Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous

ConditionInduction of Labor Affected Fetus / Newborn
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorHoly Family Hospital, Nazareth, Israel

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women above 18 years old

Sign an informed consent

Term pregnancy (>37 weeks)

Viable fetus

Disqualifiers

Previous cesarean delivery

Major fetal malformations

Contraindication to spontaneous vaginal delivery

Amniotic fluid index >25cm

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: group 1 - study groupActive comparator 1 intervention
Group B: group 2- controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

time to delivery

Time from catheter insertion to vaginal delivery.

Time frame
48 hours

Secondary outcomes

1

balloon expulsion time

The time until balloon was spontaneously expelled

Time frame
12 hours after insertion
2

Bishop score after catheter expulsion

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

Time frame
12 hours
3

Fetal presentation at the delivery

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.

Time frame
48 hours
4

Duration of the active phase of labor

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

Time frame
4 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Holy Family Hospital, Nazareth, Israel

Lead sponsor

Source ClinicalTrials.gov
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