Bicarbonate Given During Dystocic Labor

Not Applicable

Completed

• Conditions: Arrested Labor
• Interventions: Dietary Supplement: Treatment

• Registration Number: NCT02805387
• Lead Sponsor: Karolinska Institutet

Brief Summary

Dystocic deliveries and the use of bicarbonate

Detailed Description

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-12
• Study Completion: 2015-06
• Status Verified: 2016-06
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-17
• Last Update Submitted: 2016-06-17
• Study First Posted: 2016-06-20
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Treatment	Dystocic women where bicarbonate was ingested

Primary Outcome Measures

Name	Time	Method
Frequency of spontaneous vaginal delivery	during labor

Trial Locations

Locations (1)

Eva Wiberg-Itzel; 🇸🇪 Stockholm, Sweden