Bicarbonate Given During Dystocic Labor

Arrested Labor Clinical Trial

Official title:

Bicarbonate, a New Treatment of Labour Dystocia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805387
• Other study ID #: KI
• Status: Completed
• Phase: N/A
• First received: June 13, 2016
• Last updated: June 17, 2016
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Dystocic deliveries and the use of bicarbonate

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrested Labor

Intervention

Dietary Supplement:
• Treatment
Bicarbonate was ingested

Locations

Country	Name	City	State
Sweden	Eva Wiberg-Itzel	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of spontaneous vaginal delivery		during labor	No