Bicarbonate Given During Dystocic Labor

• ClinicalTrials.gov Identifier: NCT02805387
• Recruitment Status: Completed
• First Posted: June 20, 2016
• Last Update Posted: June 20, 2016
• Sponsor: Karolinska Institutet
• Information provided by (Responsible Party): Eva Wiberg-Itzel, Karolinska Institutet

Tracking Information

• First Submitted Date: June 13, 2016
• First Posted Date: June 20, 2016
• Last Update Posted Date: June 20, 2016
• Study Start Date: January 2013
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 17, 2016): Frequency of spontaneous vaginal delivery [ Time Frame: during labor ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bicarbonate Given During Dystocic Labor
• Official Title: Bicarbonate, a New Treatment of Labour Dystocia
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Arrested Labor

Intervention

Dietary Supplement: Treatment

Bicarbonate was ingested

Study Arms

• No Intervention: no treatment
  Dystocic women where no bicarbonate was given
• Experimental: Treatment
  Dystocic women where bicarbonate was ingested
  Intervention: Dietary Supplement: Treatment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 17, 2016): 200
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 2015
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT02805387
• Other Study ID Numbers: KI
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Eva Wiberg-Itzel, Karolinska Institutet
• Study Sponsor: Karolinska Institutet
• Collaborators: Not Provided

Investigators

• Study Chair: Per Tornvall, professor; Karolinska Institutet

• PRS Account: Karolinska Institutet
• Verification Date: June 2016