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Oxytocin 2024-04-11 ClinicalTrials

Randomized trial investigates **castor oil** and balloon catheter for reducing labor induction time in nulliparous women

Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous

Background

Labor induction is a common obstetric procedure, particularly for nulliparous women, where the cervix needs to be ripened before contractions can effectively begin. Current methods, such as mechanical devices like balloon catheters or pharmacological agents like prostaglandins, aim to achieve cervical ripening and shorten the time to delivery. However, there's an ongoing search for strategies to optimize these methods, potentially by combining approaches to enhance efficacy and reduce induction duration. Castor oil, a traditional remedy, is thought to stimulate uterine contractions and bowel motility, which might synergistically aid cervical ripening when combined with mechanical methods, addressing a gap in current induction protocols.

Study Design

This randomized controlled trial (RCT) aims to assess the efficacy and safety of combining castor oil ingestion with an extra-amniotic single balloon catheter for cervical ripening in nulliparous women. Participants will be randomly assigned to one of two groups. The study group will ingest 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. The control group will receive a Foley catheter inserted into the cervical canal without prior castor oil ingestion. The primary endpoint is the time from induction to delivery, with secondary endpoints including other perinatal outcomes and maternal side effects.

Results

This research record describes the design and objectives of an ongoing randomized controlled trial, rather than presenting completed findings. The study aims to answer several key questions regarding the combination of castor oil and balloon catheter for labor induction. Specifically, it seeks to determine if the addition of castor oil to an extra-amniotic single balloon catheter reduces the time until birth. Furthermore, the trial will investigate whether this combination affects other perinatal outcomes during childbirth and if the potential side effects of castor oil are well-tolerated by the mothers. As an ongoing trial, no specific numerical results, p-values, or fold-changes are available at this stage.

Why It Matters

If this trial demonstrates that combining castor oil with a balloon catheter significantly reduces the time to delivery, it could offer a simple, low-cost adjunct to existing labor induction protocols. For clinicians, this could mean a more efficient induction process, potentially reducing hospital stay duration and resource utilization. For nulliparous women undergoing induction, a shorter labor could translate to improved maternal experience and reduced fatigue. The study's focus on tolerability and perinatal outcomes is crucial, as any new protocol must prioritize safety. If successful, this combination could become a practical, accessible option for optimizing cervical ripening, potentially influencing future clinical guidelines for labor induction.


castor-oil labor-induction cervical-ripening nulliparous randomized-controlled-trial obstetrics
Source: clinicaltrials:NCT06325007 · Ingested 2026-07-16 · Digest: gemini-2.5-flash