The Effect of IV PAPAVERINE 80 mg Prior to Propess on Bishop Score and Pain, Double Blinded Randomized Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- the time from propess insertion until delivery
研究概览
简要总结
The investigators aim to evaluate the effect of administering papaverine prior to PGE2 insertion on changes in Bishop-scores and on the induction-to-delivery interval.
Researchers will compare drug papaverine to a placebo
详细描述
More than 22% of all pregnant women undergo induction of labor. Induction of labor is usually medically indicated for maternal and fetal related conditions; however, elective induction has become more common since the ARRIVE trial. Women with an unfavourable cervix, according to Bishop-score (<6), are prone to higher induction failure rates and are candidates for cervical ripening.
The cervix is composed of connective tissue and smooth-muscle located mainly beneath the internal os. Papaverine is an antispasmodic-musculotropic drug that targets smooth-muscle, resulting in decreased muscle spasm and subsequent smooth-muscle relaxation. The half-life of the drug is in the range of 0.5-2 hours, and its action starts 10 minutes after administration. Short-term use of papaverine during the first trimester has been reported as safe. However, outcome data are lacking of the use of mucosotropic-agents prior to PGE2 (propess) insertion. We will investigate this in a trial in which the co-primary outcomes were the change in Bishop-score after PGE2 extraction and the PGE2 insertion-to-delivery interval
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The group allocation will be double blind. The randomization table will be available only to one member of the study, who will prepare the medications according to the allocated intervention. Participants will receive intravenous 0.9% normal saline with or without papaverine. The same bottles of normal saline will be use for the papaverine and placebo groups. Accordingly, the participants will be masked for the intervention. The participants, the researchers including the obstetricians who inserted the PGE2 (propess), the caregiver nurse who administrated the medication, the data collector, and the statistician will be blinded to the group allocations throughout the study
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton term pregnancy
- •bishop score
- •need for labor induction with PGE2
- •vertex presentation
- •viable fetus
排除标准
- •Prelabour rupture of membrane
- •Twins pregnancy
- •previous cesarean section
- •allergy to the study medication
- •fetal anomaly contraindications for vaginal delivery
- •maternal supraventricular tachicardia
研究组 & 干预措施
papaverine arm
IV-papaverine 80 mg in 100 ml 0.9% saline, once
干预措施: Papaverine (Drug)
Control arm
I.V 100 ml 0.9% saline
干预措施: placebo (Other)
结局指标
主要结局
the time from propess insertion until delivery
时间窗: 72 hours
induction to delivery time
Delta Bishop score
时间窗: 24 hours
The bishop score before and after propess insertion
次要结局
- maternal satisfaction scores(24 hours)
- visual analogue scale score(24 hours)
研究者
Dr. Maya Wolf
Head of Fetal Maternal Unit
Western Galilee Hospital-Nahariya