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NCT06335017·Not applicable·INTERVENTIONAL

Castor Oil Ingestion and Balloon Catheter for Labor Induction in Multiparous

OxytocinOtherRecruiting

Status

Recruiting

Phase

Not applicable

Enrollment

216

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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 multiparous 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, 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, the catheter will be inserted into cervical canal without ingestion of castor oil.

Full detailed description

The rate of labor induction has increased up to 25.7% in 2018 for several demographic and obstetric reasons. 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 2 hours, a sample size of 98 in each group will be needed assuming 80% power and a two-tailed alpha of 5%. Since the success rate of vaginal delivery was nearly 95% according to the same report, the sample size was calculated to 103 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 108 women in each group (216 in both groups).

Interventions

Treatment arms and agents.

DIETARY_SUPPLEMENT

Induction of labor

In both groups the balloon catheter will be removed at nearly 12 hours after insertion. 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.

Timeline

From registration to results.

  1. First posted

    Mar 28, 2024

  2. Study start

    Apr 10, 2024

  3. Primary completion

    Nov 2026

  4. Study completion

    Dec 2026

  5. Results posted

    Not reported

  6. Registry updated

    Apr 13, 2026

Outcomes

What the study measures.

Primary outcomes

time to delivery

Time frame · 48 hours

Time from catheter insertion to vaginal delivery

Secondary outcomes

balloon expulsion time

Time frame · 12 hours after insertion

The time until balloon was spontaneously expelled

Bishop score at catheter expulsion

Time frame · 12 hours

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

Number of women that will have non-vertex presentation after removal of the catheter

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.

Duration of active phase

Time frame · 4 hours

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

Duration of second stage

Time frame · 4 hours

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

Mode of delivery

Time frame · 48 hours

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

Indications for cesarean or vacuum 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?

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

Time frame · 48 hours

Intrapartum fever ≥ 38 °C

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.

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, and tachycardia

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
60 Years
Sex
FEMALE
Healthy volunteers
Yes

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

Study locations

1 registered sites.

Israel. Showing up to 24 locations stored in the fast local snapshot.

Holy Family hospital, Nazareth

Nazareth, Israel

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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