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Castor Oil Ingestion and Balloon Catheter for Labor Induction in Multiparous

RecruitingNAAges 18 Years - 60 YearsFemaleHoly Family Hospital, Nazareth, Israel
NCT06335017 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 witho

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📋 Eligibility rules (as published)
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
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What it tests

  • Induction of labor
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Where

1 site
Holy Family hospital, Nazareth
Nazareth, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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