Clinical trial NCT06325007: Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous
Official title: The Effect of Combining Single Balloon Catheter With Castor Oil Ingestion for Cervical Ripening on Time to Delivery Among Nulliparous Women.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Holy Family Hospital, Nazareth, Israel
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: The rate of labor induction has increased up to 25.7% in 2018 for several demographic and obstetric reasons. In nulliparous women the reported rate is nearly 32%.

Various methods are used to induce labor worldwide, including natural, mechanical and pharmacological agents. of all methods balloon catheters were proven to cause fewer adverse perinatal events.

Though induction is considered a safe and effective procedure, it may lead to a prolonged labor which is associated with complications such postpartum hemorrhage, infection, and operative delivery.

Based on these data several studies have examined the combinations of balloon catheters with other pharmacological agents on labor durations. The results were inconsistent, and several reports showed that the combination reduced significantly the length of labor. Nevertheless, pharmacological agents may be associated with adverse events including uterine hyperstimulation, placental abruption, and postpartum hemorrhage, though the overall risk is small.

Castor oil, extracted from the seeds of Ricinus communis plant, is a natural effective substance for induction of labor. it's considered a safe and inexpensive though the exact mechanism by which it induces labor is still unclear.

Our hypothesis suggests that ingestion of castor oil combined with the balloon catheter will shorten the time to delivery. In order to show a reduction by 3 hours, a sample size of 57 in each group will be needed assuming 80% power and a two-tailed alpha of 5%.

Since the success rate of vaginal delivery is nearly 85%, the sample size was calculated to 67 women in each group. Additional 5% are planned to be recruited to account for trial drop out for any reason, yielding a total final sample size of 71 women in each group (142 in both groups).

Eligibility criteria: 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

Primary outcomes:
measure: time to delivery
timeFrame: 48 hours
Secondary outcomes:
measure: balloon expulsion time
timeFrame: 12 hours after insertion
measure: Bishop score after catheter expulsion
timeFrame: 12 hours
measure: Fetal presentation at the delivery
timeFrame: 48 hours
measure: Duration of the active phase of labor
timeFrame: 4 hours
measure: Duration of second stage
timeFrame: 4 hours
measure: Mode of delivery
timeFrame: 48 hours
measure: Indications for cesarean or operative vaginal deliveries
timeFrame: 48 hours
measure: Intrapartum fever
timeFrame: 48 hours
measure: Number of patients that will require use of intrapartum use of antibiotic treatment.
timeFrame: 48 hours
measure: Number of Participants with that will develop clinical signs of chorioamnionitis.
timeFrame: 48 hours
measure: Number of Participants with that will develop 3rd and 4th degrees perineal lacerations.
timeFrame: 48 hours
measure: Number of Participants with develop postpartrum hemorrhage.
timeFrame: 48 hours
measure: Number of Participants with need blood transfusion.
timeFrame: 72 hours
measure: Side effects related to castor oil use
timeFrame: 48 hours
measure: Oxytocin maximal dosage
timeFrame: 48 hours
measure: Number of participants with Umbilical Cord prolapse.
timeFrame: 48 hours
measure: Apgar score (0 to 10).
timeFrame: 48 hours
measure: pH taken from umbilical artery
timeFrame: 48 hours
measure: Neonatal birthweight
timeFrame: 48 hours
measure: Number of neonates with Neonatal fever ≥ 38 °C
timeFrame: 72 hours
measure: The number of neonates that will develop neonatal sepsis.
timeFrame: 72 hours
measure: The number of neonates that will require antibiotic treatment.
timeFrame: 72 hours
measure: Neonatal complications
timeFrame: 48 hours
measure: The number of neonates that will Admit to neonatal intensive care unit (NICU)
timeFrame: 30 days
measure: Length of stay in NICU.
timeFrame: 30 days
measure: neonatal death
timeFrame: 30 days
measure: Maternal hemoglobin level after delivery.
timeFrame: 48 hours
measure: Number of participants that will require postpartum hysterectomy.
timeFrame: 72 hours following delivery.
measure: Number of participants that will require postpartum laparotomy.
timeFrame: 72 hours following delivery.
measure: postpartum maternal complications
timeFrame: 72 hours following the delivery.
measure: The length of stay from birth to discharge home.
timeFrame: up to 10 days
measure: Maternal satisfaction from delivery process.
timeFrame: up to 10 days after delivery
Other outcomes:
Locations:
city: Nazareth
country: Israel
facility: Holy Family hospital, Nazareth
city: Nazareth
country: Israel
facility: Holy Family Hospital
Study officials:
affiliation: Holy Family Hospital, Nazareth, Israel
name: Raed Salim, MD
role: STUDY_CHAIR
References:
citation: 1.Clinical management guidelines for Obstetrician-Gynecologists. The American College of Obstetricians and Gynecologists 2009. Vol.114, No.2, Part1. 2. Grobman W, et al. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. The new England journal of medicine 2018;379;6. 3. Jones MN,et al. Balloon catheters versus vaginal prostaglandins for labour induction (CPI Collaborative): an individual participant data meta-analysis of randomised controlled trials. Lancet 2022;400:1681-1692. 4. Cheng YW, et al. The association between the length of first stage of labor, mode of delivery, and perinatal outcomes in women undergoing induction of labor. Am J Obstet Gynecol. 2009;201:477.e1-7. 5. Cheng YW, et al. Length of the first stage of labor and associated perinatal outcomes in nulliparous women. Obstet Gynecol 2010;116:1127-35. 6. Gagnon J, et al. Intracervical Foley catheter with and without oxytocin for labor induction with Bishop score ≤3: a secondary analysis. Am J Obstet Gynecol MFM 2021;3:100350. 7. Edwards RK, et al. Controlled Release Dinoprostone Insert and Foley Compared to Foley Alone: A Randomized Pilot Trial. Am J Perinatol 2021;38:e57-e63. 8. DeMariaa A, et al. Castor oil as a natural alternative to labor induction: A retrospective descriptive study. Women and Birth 2018;31:e99-e104. 9. Moradi M, et al. Effect of Castor Oil on Cervical Ripening and Labor Induction: a systematic review and meta-analysis. Journal Of Pharmacopuncture 2022;25:71-78. 10. Shalev-Ram H, et al. Is there a difference in labor patterns after induction with prostaglandins and double-balloon catheters? American Journal of Obstetrics and Gynecology 2023;3:100198. 11. Tunarua S, et al. Castor oil induces laxation and uterus contraction via ricinoleic acid activating prostaglandin EP3 receptors. Proceedings of the National Academy of Sciences 2012. 12. Kelly AJ, et al. Castor oil, bath and/or enema for cervical priming and induction of labour. Cochrane Database Syst Rev 2013;2013:CD003099. 13. Bayoumi YA, et al. Castor oil for labor initiation in women with a previous cesarean section: a double-blind randomized study. J Matern Fetal Neonatal Med 2022;35:8945-8951. 14. Gilada R, et al. Castor oil for induction of labor in post-date pregnancies: A randomized controlled trial. Women and Birth 2018;e26-e31. 15. Salim R, et al. Single-balloon compared with double-balloon catheters for induction of labor: a randomized controlled trial. Obstet Gynecol 2011;118:79-86. 16. American College of Obstetricians and Gynecologists (College); Society for Maternal-Fetal Medicine; Caughey AB, et al. Safe prevention of the primary cesarean delivery. Am J Obstet Gynecol 2014;210:179-93.