Skip to main content
OpenTrials
Completed

NCT Number: NCT02805387

Bicarbonate Given During Dystocic Labor

Dystocic deliveries and the use of bicarbonate

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arrested Labor Dystocia Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eva Wiberg-Itzel

Stockholm, 18239, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primiparity, singleton pregnancy
  • with an arrested labour progress according to the partogram with a need for oxytocin
  • Gestational age was between 37-42 weeks
  • and no maternal /fetal chronic and/or pregnancy-related conditions.

Exclusion criteria

  • 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

Treatment and study plan

Treatment

Dietary Supplement

Bicarbonate was ingested

Primary outcomes

  1. Frequency of spontaneous vaginal delivery

    Time frame: during labor

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Bicarbonate, a New Treatment of Labour Dystocia

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jun 20, 2016
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.