The Effect of Combining Balloon Catheter With Castor Oil Ingestion for Cervical Ripening on Time to Delivery Among Multiparous Women.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- time to delivery
Study Overview
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 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
group 1 - study group
Candidates will drink a mixture of 60 ml of castor oil and 140 ml of orange juice. 30 minutes later, A 22-French Foley catheter will be inserted above internal cervical os and will be filled with 60 mL of normal saline.
Intervention: Induction of labor (Dietary Supplement)
group 2- control
A foley catheter will be inserted into cervical canal as described above according to the department protocol without ingestion of castor oil.
Intervention: Induction of labor (Dietary Supplement)
Outcomes
Primary Outcomes
time to delivery
Time Frame: 48 hours
Time from catheter insertion to vaginal delivery
Secondary Outcomes
- balloon expulsion time(12 hours after insertion)
- Duration of second stage(4 hours)
- Mode of delivery(48 hours)
- Number of patients that will have intrapartum fever ≥ 38 °C(48 hours)
- The number of neonates that will require antibiotic treatment.(72 hours)
- Duration of active phase(4 hours)
- Number of Participants with develop postpartum hemorrhage.(48 hours)
- Oxytocin dosage(48 hours)
- Number of neonates that will have Apgar score (range 0 to 10) <7.(48 hours)
- Bishop score at catheter expulsion(12 hours)
- Number of women that will have non-vertex presentation after removal of the catheter(48 hours)
- Indications for cesarean or vacuum deliveries(48 hours)
- Number of patients that will require use of intrapartum use of antibiotic treatment(48 hours)
- Number of Participants with that will develop clinical signs of chorioamnionitis.(48 hours)
- Number of Participants with that will develop 3rd and 4th degrees perineal lacerations.(48 hours)
- Number of Participants with need blood transfusion.(72 hours)
- Number of participants with Umbilical Cord prolapse.(48 hours)
- number of women with cord artery pH <7.1(48 hours)
- The number of neonates that will develop neonatal sepsis.(72 hours)
- Number of women that will have side effects related to castor oil use(48 hours)
- Neonatal birthweight(48 hours)
- Number of neonates with Neonatal fever ≥ 38 °C(72 hours)
- number of neonates with any neonatal complications(48 hours)
- The number of neonates that will Admit to neonatal intensive care unit (NICU)(30 days)
- Length of stay in NICU.(30 days)
- Number of neonatal death(30 days)
- Maternal hemoglobin level after delivery.(48 hours)
- Number of participants that will require postpartum hysterectomy.(72 hours following delivery)
- Number of women that will develop postpartum complications(72 hours following the delivery.)
- The length of stay from birth to discharge home.(up to 10 days)
- Number of participants that will require postpartum laparotomy.(72 hours following delivery.)
- Maternal satisfaction(up to 10 days after delivery)
Investigators
Raed Salim, MD
Head of obstetrics and gynecology department
Holy Family Hospital, Nazareth, Israel