Induction of LaborNCT06335017
Castor Oil Ingestion and Balloon Catheter for Labor Induction in Multiparous
A study testing Induction of labor in people with Induction of Labor, run by Holy Family Hospital, Nazareth, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor
- What is being tested?
- Induction of labor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Apr 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Previous cesarean delivery
- Major fetal malformations
- Contraindication to spontaneous vaginal delivery
- Amniotic fluid index >25cm
- Chorioamnionitis at admission
- Placental abruption
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Holy Family hospital, Nazareth
Nazareth
Wiaam Khatib, MD, 0549192433, wiaam.khatib.95@gmail.com
Raed Salim, MD, r.salim@hfhosp.org
About this study
Official title: The Effect of Combining Balloon Catheter With Castor Oil Ingestion for Cervical Ripening on Time to Delivery Among Multiparous Women.
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:
Read more
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.
Read the 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.
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).
- Conditions
- Induction of Labor
- Being tested
- Induction of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of laborDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| group 1 - study group | Active comparator | 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. Receives: Dietary Supplement: Induction of labor |
| group 2- control | Active comparator | A foley catheter will be inserted into cervical canal as described above according to the department protocol without ingestion of castor oil. Receives: Dietary Supplement: Induction of labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to delivery
Time from catheter insertion to vaginal delivery
Measured: 48 hours
Secondary outcomes (32)
balloon expulsion time
The time until balloon was spontaneously expelled
Measured: 12 hours after insertion
Bishop score at catheter expulsion
Bishop score after removal of the catheter where a high score (above 7) indicates a better outcome
Measured: 12 hours
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.
Measured: 48 hours
Duration of active phase
Duration of the time from 6 cm cervical dilatation to 10 cm cervical dilatation
Measured: 4 hours
Duration of second stage
the time from 10 cm cervical dilatation until the delivery of the baby
Measured: 4 hours
Mode of delivery
Whether the birth was a normal spontaneous birth, operative vaginal birth or a cesarean section
Measured: 48 hours
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?
Measured: 48 hours
Number of patients that will have intrapartum fever ≥ 38 °C
Intrapartum fever ≥ 38 °C
Measured: 48 hours
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.
Measured: 48 hours
Number of Participants with that will develop clinical signs of chorioamnionitis.
Clinical signs of chorioamnionitis includes abdominal tenderness, abnormal discharge, intrapartum fever, and tachycardia
Measured: 48 hours
Number of Participants with that will develop 3rd and 4th degrees perineal lacerations.
Obstetric anal sphincter injury
Measured: 48 hours
Number of Participants with develop postpartum hemorrhage.
early postpartum hemorrhage (PPH)
Measured: 48 hours
Number of Participants with need blood transfusion.
PPH that will require blood transfusion.
Measured: 72 hours
Number of women that will have side effects related to castor oil use
nausea, vomiting, uterine hyperstimulation> the 5 contractions: 10 minutes
Measured: 48 hours
Oxytocin dosage
A higher oxytocin dosage indicates lesser outcome.
Measured: 48 hours
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.
Measured: 48 hours
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.
Measured: 48 hours
number of women with cord artery pH <7.1
pH taken from umbilical artery (lower pH means worse outcome)
Measured: 48 hours
Neonatal birthweight
Neonatal birthweight
Measured: 48 hours
Number of neonates with Neonatal fever ≥ 38 °C
Neonatal fever > 38 °C
Measured: 72 hours
The number of neonates that will develop neonatal sepsis.
Diagnosis of neonatal sepsis based on clinical signs of sepsis and positive cultures.
Measured: 72 hours
The number of neonates that will require antibiotic treatment.
Need for antibiotic treatment
Measured: 72 hours
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
Measured: 48 hours
The number of neonates that will Admit to neonatal intensive care unit (NICU)
Neonatal admission to NICU
Measured: 30 days
Length of stay in NICU.
Neonatal length of stay in NICU
Measured: 30 days
Number of neonatal death
neonatal death
Measured: 30 days
Maternal hemoglobin level after delivery.
higher level of Hemoglobin indicates better outcome.
Measured: 48 hours
Number of participants that will require postpartum hysterectomy.
Maternal hysterectomy
Measured: 72 hours following delivery
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.
Measured: 72 hours following delivery.
Number of women that will develop postpartum complications
endometritis
Measured: 72 hours following the delivery.
The length of stay from birth to discharge home.
The length of stay in days from birth to discharge home.
Measured: up to 10 days
Maternal satisfaction
1 = Very dissatisfied, 10 = Very satisfied
Measured: up to 10 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start10 Apr 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holy Family Hospital, Nazareth, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raed Salim, MD, Holy Family Hospital, Nazareth, Israel
- Investigators
- Raed Salim, MD, Study chair, Holy Family Hospital, Nazareth, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335017
- Sponsor's protocol ID
- 294-2024-HFH
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combining Balloon Catheter With Castor Oil Ingestion for Cervical Ripening on Time to Delivery Among Multiparous Women.
- ClinicalTrials.gov ID
- NCT06335017
- Acronym / sponsor ID
- 294-2024-HFH
- Conditions
- Induction of Labor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Holy Family Hospital, Nazareth, IsraelUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 - study group | Active comparator | Dietary Supplement: Induction of laborCandidates 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. |
| group 2- control | Active comparator | Dietary Supplement: Induction of laborA foley catheter will be inserted into cervical canal as described above according to the department protocol without ingestion of castor oil. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women above 18 years old
- Sign an informed consent
- Term pregnancy (>37 weeks)
- Viable fetus
- Singleton
Key exclusion criteria (11 listed)
- Previous cesarean delivery
- Major fetal malformations
- Contraindication to spontaneous vaginal delivery
- Amniotic fluid index >25cm
- Chorioamnionitis at admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induction of laborIn 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. | Dietary supplement | group 1 - study group, group 2- control |
Primary outcome
time to delivery
Time frame: 48 hours
Time from catheter insertion to vaginal delivery
32 secondary outcomes
balloon expulsion time
Time frame: 12 hours after insertion
Bishop score at catheter expulsion
Time frame: 12 hours
Number of women that will have non-vertex presentation after removal of the catheter
Time frame: 48 hours
Duration of active phase
Time frame: 4 hours
Duration of second stage
Time frame: 4 hours
Mode of delivery
Time frame: 48 hours
Indications for cesarean or vacuum deliveries
Time frame: 48 hours
Number of patients that will have intrapartum fever ≥ 38 °C
Time frame: 48 hours
Number of patients that will require use of intrapartum use of antibiotic treatment
Time frame: 48 hours
Number of Participants with that will develop clinical signs of chorioamnionitis.
Time frame: 48 hours
Number of Participants with that will develop 3rd and 4th degrees perineal lacerations.
Time frame: 48 hours
Number of Participants with develop postpartum hemorrhage.
Time frame: 48 hours
Number of Participants with need blood transfusion.
Time frame: 72 hours
Number of women that will have side effects related to castor oil use
Time frame: 48 hours
Oxytocin dosage
Time frame: 48 hours
Number of participants with Umbilical Cord prolapse.
Time frame: 48 hours
Number of neonates that will have Apgar score (range 0 to 10) <7.
Time frame: 48 hours
number of women with cord artery pH <7.1
Time frame: 48 hours
Neonatal birthweight
Time frame: 48 hours
Number of neonates with Neonatal fever ≥ 38 °C
Time frame: 72 hours
The number of neonates that will develop neonatal sepsis.
Time frame: 72 hours
The number of neonates that will require antibiotic treatment.
Time frame: 72 hours
number of neonates with any neonatal complications
Time frame: 48 hours
The number of neonates that will Admit to neonatal intensive care unit (NICU)
Time frame: 30 days
Length of stay in NICU.
Time frame: 30 days
Number of neonatal death
Time frame: 30 days
Maternal hemoglobin level after delivery.
Time frame: 48 hours
Number of participants that will require postpartum hysterectomy.
Time frame: 72 hours following delivery
Number of participants that will require postpartum laparotomy.
Time frame: 72 hours following delivery.
Number of women that will develop postpartum complications
Time frame: 72 hours following the delivery.
The length of stay from birth to discharge home.
Time frame: up to 10 days
Maternal satisfaction
Time frame: up to 10 days after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raed Salim, MD study chair
Holy Family Hospital, Nazareth, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction of labor in people with Induction of Labor, run by Holy Family Hospital, Nazareth, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raed Salim, MD (: +972544986960, r.salim@hfhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to delivery (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.