Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

The Effect of Combining Single Balloon Catheter With Castor Oil Ingestion for Cervical Ripening on Time to Delivery Among Nulliparous Women.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325007
• Other study ID #: 293-2024-HFH
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Holy Family Hospital, Nazareth, Israel
• Contact: Raed Salim, MD
• Phone: +972544986960
• Email: r.salim[@]hfhosp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: December 31, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Dietary Supplement:
• Induction of labor
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

Country	Name	City	State
Israel	Holy Family Hospital	Nazareth
Israel	Holy Family hospital, Nazareth	Nazareth

Sponsors (1)

Lead Sponsor	Collaborator
Holy Family Hospital, Nazareth, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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 En

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to delivery	Time from catheter insertion to vaginal delivery.	48 hours
Secondary	balloon expulsion time	The time until balloon was spontaneously expelled	12 hours after insertion
Secondary	Bishop score after catheter expulsion	Bishop score after removal of the catheter where a high score (above 7) indicates a better outcome.	12 hours
Secondary	Fetal presentation at the delivery	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.	48 hours
Secondary	Duration of the active phase of labor	Duration of the time from 6 cm cervical dilatation to 10 cm cervical dilatation	4 hours
Secondary	Duration of second stage	the time from 10 cm cervical dilatation until the delivery of the baby	4 hours
Secondary	Mode of delivery	Whether the birth was a normal spontaneous birth, operative vaginal birth or a cesarean section.	48 hours
Secondary	Indications for cesarean or operative vaginal deliveries	Was the reason for operative vaginal delivery or cesarean delivery due to non progress labor, fetal status, or a combination of both?	48 hours
Secondary	Intrapartum fever	Number of patients that will have intrapartum fever = 38 °C	48 hours
Secondary	Number of patients that will require use of intrapartum use of antibiotic treatment.	Number of patients that will require use of intrapartum use of antibiotic treatment due to intrapartum infection.	48 hours
Secondary	Number of Participants with that will develop clinical signs of chorioamnionitis.	Clinical signs of chorioamnionitis includes abdominal tenderness, abnormal discharge, intrapartum fever, tachycardia	48 hours
Secondary	Number of Participants with that will develop 3rd and 4th degrees perineal lacerations.	Obstetric anal sphincter injury	48 hours
Secondary	Number of Participants with develop postpartrum hemorrhage.	early postpartum hemorrhage (PPH)	48 hours
Secondary	Number of Participants with need blood transfusion.	PPH that required blood transfusion	72 hours
Secondary	Side effects related to castor oil use	nausea, vomiting, uterine hyperstimulation> the 5 contractions: 10 minutes	48 hours
Secondary	Oxytocin maximal dosage	Oxytocin maximal dosage	48 hours
Secondary	Number of participants with Umbilical Cord prolapse.	Umbilical cord prolapse is when the umbilical cord exits the cervical os before the fetal presenting part that may result in fetal hypoxia.	48 hours
Secondary	Apgar score (0 to 10).	APGAR< 7 after 1 and 5 minutes where lower scores mean a worse outcome.	48 hours
Secondary	pH taken from umbilical artery	Cord artery pH <7.1	48 hours
Secondary	Neonatal birthweight	Neonatal birthweight	48 hours
Secondary	Number of neonates with Neonatal fever = 38 °C	Neonatal fever >38	72 hours
Secondary	The number of neonates that will develop neonatal sepsis.	Diagnosis of neonatal sepsis based on clinical signs of sepsis and positive cultures.	72 hours
Secondary	The number of neonates that will require antibiotic treatment.	Need for antibiotic treatment	72 hours
Secondary	Neonatal complications	respiratory distress syndrome, transient tachypnea of newborn, intracranial hemorrhage, intraventricular hemorrhage, seizures, Meconium aspiration syndrome ,Hypoxic ischemic encephalopathy	48 hours
Secondary	The number of neonates that will Admit to neonatal intensive care unit (NICU)	Neonatal admission to NICU	30 days
Secondary	Length of stay in NICU.	Neonatal length of stay in NICU.	30 days
Secondary	neonatal death	neonatal death	30 days
Secondary	Maternal hemoglobin level after delivery.	higher level of Hemoglobin and indicate better outcome.	48 hours
Secondary	Number of participants that will require postpartum hysterectomy.	Maternal hysterectomy	72 hours following delivery.
Secondary	Number of participants that will require postpartum laparotomy.	Number of participants that will require postpartum laparotomy after vaginal delivery or re-laparotomy after cesarean section.	72 hours following delivery.
Secondary	postpartum maternal complications	endometritis	72 hours following the delivery.
Secondary	The length of stay from birth to discharge home.	The length of stay in days from birth to discharge home.	up to 10 days
Secondary	Maternal satisfaction from delivery process.	1 = Very dissatisfied, 10 = Very satisfied	up to 10 days after delivery