Effect of Heated Saline in Duration of Cervical Ripening in Women Having Labor Induction With Cervical Balloon: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- To determine if the use of heated saline in the Balloon Catheter (BC), used for cervical ripening, reduces the length of BC duration, defined as the time from the insertion to spontaneous expulsion or artificial removal of the BC.
研究概览
简要总结
This study is a single-center, randomized, two-arm, controlled trial, including women requiring cervical ripening during the process Induction of Labor using Balloon catheter (BC). The primary objective of the study is to determine if the use of heated saline in the BC used for cervical ripening reduces the length of BC duration.
Participants will be allocated to :
- Intervention or warm group: the BC will be filled with heated saline water up to 40° C
- Standard or room temperature group: the BC will be filled with saline water at room temperature.
详细描述
Background and Rationale:
Induction of Labor (IOL) is one of the most common interventions in obstetrics. IOL is performed due to fetal, maternal or pregnancy complications to reduce the risk of complication. IOL methods will depend of the state of the cervix at the beginning of the procedure. If cervix is considered unfavorable (Bishop score ≤ 5) an initial phase of ripening is usually proposed. There are various methods of cervical ripening, which can be divided into non-pharmacological (e.g., mechanical methods with transcervical Foley catheter or Cook balloon) and pharmacological (e.g., prostaglandins). IOL can be a long-lasting procedure, especially when cervical ripening is necessary.
Two recent, small studies have shown that the use of warm fluid to inflate the balloon catheter (BC) inserted through the cervix reduces the time of cervical ripening, hence potentially reducing the time of IOL. These results are the only data available regarding the use of saline at different temperatures for inflating the balloon in mechanical methods and show promising effects in terms of reduction in the length of the cervical ripening and labor.
The cervix is mainly composed of collagen. Studies show that the use of heat on connective tissue increase the potential elongation of collagen tissue and the denaturation of this protein.
We hypothesize that the use of heat in the cervical ripening can accelerate the denaturation of the collagen and accelerate the softening of the cervix and therefore reduce the duration of cervical ripening and labor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age at or over 35 weeks
- •Singleton pregnancy
- •Alive fetus
- •Cephalic presentation
- •Maternal age ≥ 16 years
排除标准
- •Active labor (dilated cervix with spontaneous uterine contractions)
- •Prelabor rupture of membranes
- •>1 Previous cesarean delivery
- •Fetal malformation leading to a possible obstruction of labor (e.g., hydrocephaly, exteriorized fetal tumors, etc.)
- •Maternal or fetal disease with indication to accelerate labor (start oxytocin stimulation within 6 hours after insertion of the BC (e.g., pre-eclampsia, chorioamnionitis, etc.)]
- •Counterindication to vaginal delivery
- •Impossibility to give consent to participation
研究组 & 干预措施
Warm group
The Balloon Catheter will be filled with heated saline water up to 40° C
干预措施: Warm group (Device)
Room temperature group
the Balloon Catheter will be filled with saline water at room temperature.
干预措施: Room temperature group (Device)
结局指标
主要结局
To determine if the use of heated saline in the Balloon Catheter (BC), used for cervical ripening, reduces the length of BC duration, defined as the time from the insertion to spontaneous expulsion or artificial removal of the BC.
时间窗: Through study completion, an average of 1.5 years
Duration of BC (i.e., positioning of the transcervical catheter): interval between insertion and retrieval, either after spontaneous expulsion or artificial retrieval.
次要结局
- Increases the rate and the speed of spontaneous rupture of membranes (ROM) during cervical ripening(Through study completion, an average of 1.5 years)
- Decreases the length from the start of the induction until the delivery(Through study completion, an average of 1.5 years)
- To evaluate if the use of heated saline compared with room temperature Decreases the length from the start of the induction until the achievement of a favorable cervix (Bishop score >5)(Through study completion, an average of 1.5 years)
- Impacts on the rate of cesarean delivery(Through study completion, an average of 1.5 years)
- Decreases the length from the start of the induction until full dilation(Through study completion, an average of 1.5 years)
- Impacts on the pain and the satisfaction in women undergoing cervical ripening(Through study completion, an average of 1.5 years)
- Impacts on obstetrical and neonatal complications(Through study completion, an average of 1.5 years)
研究者
Begona Martinez de Tejada
Professor
University Hospital, Geneva