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.
Women above 18 years old
Sign an informed consent
Term pregnancy (>37 weeks)
Viable fetus
Previous cesarean delivery
Major fetal malformations
Contraindication to spontaneous vaginal delivery
Amniotic fluid index >25cm
Parallel
Induction of labor
Dietary supplementIn both groups the balloon catheter will be removed at nearly 12 hours after insertion. 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.
time to delivery
Time from catheter insertion to vaginal delivery
balloon expulsion time
The time until balloon was spontaneously expelled
Bishop score at catheter expulsion
Bishop score after removal of the catheter where a high score (above 7) indicates a better outcome
Number of women that will have non-vertex presentation after removal of the catheter
The insertion of a balloon may lead to a change in the presenting part of the fetus. A change to a non-vertex presentation is carried as an undesired outcome.
Duration of active phase
Duration of the time from 6 cm cervical dilatation to 10 cm cervical dilatation
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