Prospective randomized clinical trial comparing the effect of vaginal misoprostol synchronously with supracervical ball, versus only vaginal misoprostol for induction of labor.

Consorci Sanitari de Terrassa0 个研究点开始时间: 2016年1月13日最近更新: 2016年5月17日

适应症

试验速览

暂无简介。

•Pegnant women with a term singleton pregnancy, cephalic presentation, reassuring fetal heart rate pattern, intact membranes and an unfavorable cervix (Bishop score less than 6), admitted to our institution for labour induction.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1- Exclusion criteria pre-randomization:
•- Patient refusal to participate in the trial
•- Misoprostol contraindication acording to the misoprostol leaflet:
•- Severe Preeclampsia
•- Prematurity (<37 weeks gestation dated by first trimester ultrasound)
•- Previous cesarean section or previous uterine surgery
•- Intrauterine growth restriction
•- Whenever placement of supracervical balloon might lead to an increase in the risk of infections and chorioamnionitis:
•- Premature rupture of membranes
•- Maternal colonization with Streptococcus agalactiae at any time during the pregnancy
•- Other infrequent situations that may act as a confounder factor:
•- Multifetal gestation
•- Breech presentation
•- Stillbirth
•2- Exclusion criteria postrandomization
•- Maternal leaving of the study during induction
•- Adverse effects secondary to the supracervical balloon, such as pain or maternal discomfort

发起方

Consorci Sanitari de Terrassa