Induction of Labor
Conditions
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. 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).
Interventions
DIETARY_SUPPLEMENTInduction 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.
Sponsors
Holy Family Hospital, Nazareth, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to delivery | 48 hours | Time from catheter insertion to vaginal delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| balloon expulsion time | 12 hours after insertion | The time until balloon was spontaneously expelled |
| Bishop score at catheter expulsion | 12 hours | Bishop score after removal of the catheter where a high score (above 7) indicates a better outcome |
| Number of women that will have non-vertex presentation after removal of the catheter | 48 hours | 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. |
| Duration of active phase | 4 hours | Duration of the time from 6 cm cervical dilatation to 10 cm cervical dilatation |
| Duration of second stage | 4 hours | the time from 10 cm cervical dilatation until the delivery of the baby |
| Mode of delivery | 48 hours | Whether the birth was a normal spontaneous birth, operative vaginal birth or a cesarean section |
| Indications for cesarean or vacuum deliveries | 48 hours | Was the reason for operative vaginal delivery or cesarean delivery due to non progress labor, fetal status, or a combination of both? |
| Number of patients that will have intrapartum fever ≥ 38 °C | 48 hours | Intrapartum fever ≥ 38 °C |
| Number of patients that will require use of intrapartum use of antibiotic treatment | 48 hours | Number of patients that will require use of intrapartum use of antibiotic treatment due to intrapartum infection. |
| Number of Participants with that will develop clinical signs of chorioamnionitis. | 48 hours | Clinical signs of chorioamnionitis includes abdominal tenderness, abnormal discharge, intrapartum fever, and tachycardia |
| Number of Participants with that will develop 3rd and 4th degrees perineal lacerations. | 48 hours | Obstetric anal sphincter injury |
| Number of Participants with develop postpartum hemorrhage. | 48 hours | early postpartum hemorrhage (PPH) |
| Number of Participants with need blood transfusion. | 72 hours | PPH that will require blood transfusion. |
| Number of women that will have side effects related to castor oil use | 48 hours | nausea, vomiting, uterine hyperstimulation\> the 5 contractions: 10 minutes |
| Oxytocin dosage | 48 hours | A higher oxytocin dosage indicates lesser outcome. |
| Number of participants with Umbilical Cord prolapse. | 48 hours | Umbilical cord prolapse is when the umbilical cord exits the cervical os before the fetal presenting part that may result in fetal hypoxia. |
| Number of neonates that will have Apgar score (range 0 to 10) <7. | 48 hours | APGAR\< 7 after 1 and 5 minutes where lower scores mean a worse outcome. |
| number of women with cord artery pH <7.1 | 48 hours | pH taken from umbilical artery (lower pH means worse outcome) |
| Neonatal birthweight | 48 hours | Neonatal birthweight |
| Number of neonates with Neonatal fever ≥ 38 °C | 72 hours | Neonatal fever \> 38 °C |
| The number of neonates that will develop neonatal sepsis. | 72 hours | Diagnosis of neonatal sepsis based on clinical signs of sepsis and positive cultures. |
| The number of neonates that will require antibiotic treatment. | 72 hours | Need for antibiotic treatment |
| number of neonates with any neonatal complications | 48 hours | respiratory distress syndrome, transient tachypnea of newborn, intracranial hemorrhage, intraventricular hemorrhage, seizures, Meconium aspiration syndrome ,Hypoxic ischemic encephalopathy |
| The number of neonates that will Admit to neonatal intensive care unit (NICU) | 30 days | Neonatal admission to NICU |
| Length of stay in NICU. | 30 days | Neonatal length of stay in NICU |
| Number of neonatal death | 30 days | neonatal death |
| Maternal hemoglobin level after delivery. | 48 hours | higher level of Hemoglobin indicates better outcome. |
| Number of participants that will require postpartum hysterectomy. | 72 hours following delivery | Maternal hysterectomy |
| Number of participants that will require postpartum laparotomy. | 72 hours following delivery. | Number of participants that will require postpartum laparotomy after vaginal delivery or re-laparotomy after cesarean section. |
| Number of women that will develop postpartum complications | 72 hours following the delivery. | endometritis |
| The length of stay from birth to discharge home. | up to 10 days | The length of stay in days from birth to discharge home. |
| Maternal satisfaction | up to 10 days after delivery | 1 = Very dissatisfied, 10 = Very satisfied |
Countries
Israel
Contacts
CONTACTRaed Salim, MD
CONTACTWiaam Khatib, MD
STUDY_CHAIRRaed Salim, MD
Holy Family Hospital, Nazareth, Israel
Outcome results
None listed