protocolSection identificationModule nctId: NCT06335017, orgStudyIdInfo id: 294-2024-HFH, briefTitle: Castor Oil Ingestion and Balloon Catheter for Labor Induction in Multiparous, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Holy Family Hospital, Nazareth, Israel, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Induction of Labor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 216, type: ESTIMATED, armsInterventionsModule interventions name: Induction of labor, outcomesModule primaryOutcomes measure: time to delivery, secondaryOutcomes measure: balloon expulsion time, secondaryOutcomes measure: Bishop score at catheter expulsion, secondaryOutcomes measure: Number of women that will have non-vertex presentation after removal of the catheter, secondaryOutcomes measure: Duration of active phase, secondaryOutcomes measure: Duration of second stage, secondaryOutcomes measure: Mode of delivery, secondaryOutcomes measure: Indications for cesarean or vacuum deliveries, secondaryOutcomes measure: Number of patients that will have intrapartum fever ≥ 38 °C, secondaryOutcomes measure: Number of patients that will require use of intrapartum use of antibiotic treatment, secondaryOutcomes measure: Number of Participants with that will develop clinical signs of chorioamnionitis., secondaryOutcomes measure: Number of Participants with that will develop 3rd and 4th degrees perineal lacerations., secondaryOutcomes measure: Number of Participants with develop postpartum hemorrhage., secondaryOutcomes measure: Number of Participants with need blood transfusion., secondaryOutcomes measure: Number of women that will have side effects related to castor oil use, secondaryOutcomes measure: Oxytocin dosage, secondaryOutcomes measure: Number of participants with Umbilical Cord prolapse., secondaryOutcomes measure: Number of neonates that will have Apgar score (range 0 to 10) <7., secondaryOutcomes measure: number of women with cord artery pH <7.1, secondaryOutcomes measure: Neonatal birthweight, secondaryOutcomes measure: Number of neonates with Neonatal fever ≥ 38 °C, secondaryOutcomes measure: The number of neonates that will develop neonatal sepsis., secondaryOutcomes measure: The number of neonates that will require antibiotic treatment., secondaryOutcomes measure: number of neonates with any neonatal complications, secondaryOutcomes measure: The number of neonates that will Admit to neonatal intensive care unit (NICU), secondaryOutcomes measure: Length of stay in NICU., secondaryOutcomes measure: Number of neonatal death, secondaryOutcomes measure: Maternal hemoglobin level after delivery., secondaryOutcomes measure: Number of participants that will require postpartum hysterectomy., secondaryOutcomes measure: Number of participants that will require postpartum laparotomy., secondaryOutcomes measure: Number of women that will develop postpartum complications, secondaryOutcomes measure: The length of stay from birth to discharge home., secondaryOutcomes measure: Maternal satisfaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Holy Family hospital, Nazareth, status: RECRUITING, city: Nazareth, country: Israel, contacts name: Wiaam Khatib, MD, role: CONTACT, phone: 0549192433, email: wiaam.khatib.95@gmail.com, contacts name: Raed Salim, MD, role: CONTACT, email: r.salim@hfhosp.org, contacts name: Wiaam Khatib, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.69925, lon: 35.30483, hasResults: False