Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous
The Effect of Combining Single Balloon Catheter With Castor Oil Ingestion for Cervical Ripening on Time to Delivery Among Nulliparous Women.
Holy Family Hospital, Nazareth, Israel
142 participants
Apr 11, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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 Criteria11
- 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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Interventions
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 regular uterine contractions per 10 minutes). Continuous electronic fetal monitoring will be used throughout labor. Labor will be managed by the attending obstetricians and midwives. Labor progress abnormalities will be diagnosed and managed according to the department protocol based on the recommendations of the American College of Obstetricians and Gynecologists.
Locations(2)
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NCT06325007