Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Induction of labor.
- Who it may be relevant to
- Registry conditions: Induction of Labor Affected Fetus / Newborn. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Combining Single Balloon Catheter With Castor Oil Ingestion for Cervical Ripening on Time to Delivery Among Nulliparous Women.
Overview
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.
Detailed description
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).
Interventions
- Dietary supplement Induction of labor
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 regula
Primary outcome measures
- time to delivery [Time frame: 48 hours]
Secondary outcome measures (12)
- balloon expulsion time [Time frame: 12 hours after insertion]
- Bishop score after catheter expulsion [Time frame: 12 hours]
- Fetal presentation at the delivery [Time frame: 48 hours]
- Duration of the active phase of labor [Time frame: 4 hours]
- Duration of second stage [Time frame: 4 hours]
- Mode of delivery [Time frame: 48 hours]
- Indications for cesarean or operative vaginal deliveries [Time frame: 48 hours]
- Intrapartum fever [Time frame: 48 hours]
- Number of patients that will require use of intrapartum use of antibiotic treatment. [Time frame: 48 hours]
- Number of Participants with that will develop clinical signs of chorioamnionitis. [Time frame: 48 hours]
- Number of Participants with that will develop 3rd and 4th degrees perineal lacerations. [Time frame: 48 hours]
- Number of Participants with develop postpartrum hemorrhage. [Time frame: 48 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Israel · 2 centers
- Holy Family hospital, Nazareth — Nazareth
- Holy Family Hospital — Nazareth
Publications
- 1.Clinical management guidelines for Obstetrician-Gynecologists. The American College of Obstetricians and Gynecologists 2009. Vol.114, No.2, Part1. 2. Grobman W, et al. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. The new England journal of medicine 2018;379;6. 3. Jones MN,et al. Balloon catheters versus vaginal prostaglandins for labour induction (CPI Collaborative)
Identifiers
NCT: NCT06325007 · 293-2024-HFH