Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325007
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-03-05
Brief Title:
Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous
Sponsor:
Holy Family Hospital Nazareth Israel
Organization:
Holy Family Hospital Nazareth Israel
Study Overview
Official Title:
The Effect of Combining Single Balloon Catheter With Castor Oil Ingestion for Cervical Ripening on Time to Delivery Among Nulliparous Women
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 257 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 its 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
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 its 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None