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Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 15, 2025 to Nov 15, 2026
    • Study completion date: Mar 31, 2026 to Dec 31, 2026
    v5
  2. Primary completion date: Dec 15, 2024 to Dec 15, 2025
    • Study completion date: Dec 31, 2024 to Mar 31, 2026
    v4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Oct 15, 2024 to Dec 15, 2024
    • Study completion date: Nov 15, 2024 to Dec 31, 2024
    • Start date changed from estimate of Apr 2024 to Apr 11, 2024
    • Site details revised at 2 of 2 sites
  4. Start date: Mar 15, 2024 to Apr 2024v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06325007
Lead Sponsor Holy Family Hospital, Nazareth, Israel
Conditions
(from sponsor)		 Induction of Labor Affected Fetus / Newborn
Enrollment 142 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov