The Effect of Combining Single Balloon Catheter With Castor Oil Ingestion for Cervical Ripening on Time to Delivery Among Nulliparous Women.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- time to delivery
研究概览
简要总结
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.
详细描述
The rate of labor induction has increased up to 25.7% 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. it's considered a safe and inexpensive though the exact mechanism by which it induces labor is still unclear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
干预措施: Induction of labor (Dietary Supplement)
结局指标
主要结局
time to delivery
时间窗: 48 hours
Time from catheter insertion to vaginal delivery.
次要结局
- pH taken from umbilical artery(48 hours)
- Number of neonates with Neonatal fever ≥ 38 °C(72 hours)
- Bishop score after catheter expulsion(12 hours)
- Fetal presentation at the delivery(48 hours)
- Maternal hemoglobin level after delivery.(48 hours)
- Indications for cesarean or operative vaginal deliveries(48 hours)
- Number of Participants with that will develop 3rd and 4th degrees perineal lacerations.(48 hours)
- balloon expulsion time(12 hours after insertion)
- Duration of the active phase of labor(4 hours)
- Duration of second stage(4 hours)
- Intrapartum fever(48 hours)
- Mode of delivery(48 hours)
- Number of Participants with need blood transfusion.(72 hours)
- Number of patients that will require use of intrapartum use of antibiotic treatment.(48 hours)
- Number of Participants with develop postpartrum hemorrhage.(48 hours)
- Number of Participants with that will develop clinical signs of chorioamnionitis.(48 hours)
- Side effects related to castor oil use(48 hours)
- Oxytocin maximal dosage(48 hours)
- The number of neonates that will require antibiotic treatment.(72 hours)
- Number of participants with Umbilical Cord prolapse.(48 hours)
- Apgar score (0 to 10).(48 hours)
- Neonatal birthweight(48 hours)
- The number of neonates that will Admit to neonatal intensive care unit (NICU)(30 days)
- postpartum maternal complications(72 hours following the delivery.)
- The number of neonates that will develop neonatal sepsis.(72 hours)
- Length of stay in NICU.(30 days)
- Neonatal complications(48 hours)
- neonatal death(30 days)
- Number of participants that will require postpartum hysterectomy.(72 hours following delivery.)
- The length of stay from birth to discharge home.(up to 10 days)
- Maternal satisfaction from delivery process.(up to 10 days after delivery)
- Number of participants that will require postpartum laparotomy.(72 hours following delivery.)
研究者
Raed Salim, MD
head of obstetrics and gynecology department
Holy Family Hospital, Nazareth, Israel