Clinical Trial: Bicarbonate Given During Dystocic Labor

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Bicarbonate, a New Treatment of Labour Dystocia

Brief Summary: Dystocic deliveries and the use of bicarbonate

Detailed Summary: A randomized controlled trial of 200 primiparous women in active labour.If cervical dilation crossed the action line in the partogram or if labour progress was arrested for two hours or more the delivery was considered to be dystocic, and Oxytocin was suggested for stimulation. Inclusion criteria were: primiparity, singleton pregnancy, with an arrested labour progress with a need for oxytocin. Gestational age was between 37-42 weeks, and no maternal /fetal chronic and/or pregnancy-related conditions. Excluded were multiparous women, deliveries with non-cephalic presentation, multiples, deliveries with fetal chronic and/or pregnancy-related conditions, IUFD (Intra Uterine Fetal Death) or premature < 37 weeks of gestation. A randomization into two groups was performed. One group was treated with two bags of Samarin® (=Samarin® group, 5g bicarbonate) one hour before stimulation with oxytocin started. The other group (=nonSamarin® group) received no bicarbonate and started oxytocin immediately, according to local clinical guidelines. Maternal and fetal data was collected from medical files after delivery and analysed according to group.
Sponsor: Karolinska Institutet

Current Primary Outcome: Frequency of spontaneous vaginal delivery [ Time Frame: during labor ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Karolinska Institutet

Dates:
Date Received: June 13, 2016
Date Started: January 2013
Date Completion:
Last Updated: June 17, 2016
Last Verified: June 2016