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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06335017
Other study ID # 294-2024-HFH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 10, 2024
Est. completion date December 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
Health authority
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 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.


Description:

The rate of labor induction has increased up to 25.7% in 2018 for several demographic and obstetric reasons. 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 2 hours, a sample size of 98 in each group will be needed assuming 80% power and a two-tailed alpha of 5%. Since the success rate of vaginal delivery was nearly 95% according to the same report, the sample size was calculated to 103 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 108 women in each group (216 in both groups).


Recruitment information / eligibility

Status Recruiting
Enrollment 216
Est. completion date December 2024
Est. primary completion date December 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Induction of labor
In 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.

Locations

Country Name City State
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. ACOG 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

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 at catheter expulsion Bishop score after removal of the catheter where a high score (above 7) indicates a better outcome 12 hours
Secondary 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. 48 hours
Secondary Duration of active phase 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 vacuum 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 Number of patients that will have intrapartum fever = 38 °C 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, and 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 postpartum hemorrhage. early postpartum hemorrhage (PPH) 48 hours
Secondary Number of Participants with need blood transfusion. PPH that will require blood transfusion. 72 hours
Secondary Number of women that will have side effects related to castor oil use nausea, vomiting, uterine hyperstimulation> the 5 contractions: 10 minutes 48 hours
Secondary Oxytocin dosage A higher oxytocin dosage indicates lesser outcome. 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 Number of neonates that will have Apgar score (range 0 to 10) <7. APGAR< 7 after 1 and 5 minutes where lower scores mean a worse outcome. 48 hours
Secondary number of women with cord artery pH <7.1 pH taken from umbilical artery (lower pH means worse outcome) 48 hours
Secondary Neonatal birthweight Neonatal birthweight 48 hours
Secondary Number of neonates with Neonatal fever = 38 °C Neonatal fever > 38 °C 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 number of neonates with any 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 Number of neonatal death neonatal death 30 days
Secondary Maternal hemoglobin level after delivery. higher level of Hemoglobin indicates 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 Number of women that will develop postpartum 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 1 = Very dissatisfied, 10 = Very satisfied up to 10 days after delivery
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