A Double-blind Randomized Placebo-controlled Trial to Assess Oral Bicarbonate and Intravenous Butylscopolamine Bromide for Safer Labor Induction in Pregnant Women

What this Trial Is About

Labor induction rates have been increasing steadily, with over one in four births in Norway currently occurring after induced labor. While certain groups of women benefit from labor induction, such as those with preeclampsia or gestational diabetes, induction can also increase the risk of complications like cesarean section and operative deliveries. This research aims to evaluate the effects of oral bicarbonate and intravenous butylscopolamine bromide in helping pregnant women with labor induction have spontaneous, non-operative births. The trial is a double-blind, randomized, placebo-controlled study with four groups. Participants receive combinations of oral bicarbonate or placebo and intravenous butylscopolamine bromide or placebo. The butylscopolamine bromide is given as a 1 mL intravenous injection, while bicarbonate or placebo is taken orally at a 4 g dose. This study assesses the impact of these medications on labor outcomes among pregnant women undergoing labor induction. Participants will be monitored throughout their labor, with researchers observing whether births are spontaneous or operative. The main outcome measured is the type of delivery, observed during the study period which lasts about one week through to birth. Safety and effectiveness are evaluated by comparing delivery outcomes across the different treatment groups. The study includes assessments related to labor progress and maternal and fetal conditions during delivery.

SAINT: Safe Induction of Labor Trial