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Bicarbonate Given During Dystocic Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805387
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
Eva Wiberg-Itzel, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE June 13, 2016
First Posted Date  ICMJE June 20, 2016
Last Update Posted Date June 20, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2016)
Frequency of spontaneous vaginal delivery [ Time Frame: during labor ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bicarbonate Given During Dystocic Labor
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arrested Labor
Intervention  ICMJE Dietary Supplement: Treatment
Bicarbonate was ingested
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2016)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02805387
Other Study ID Numbers  ICMJE KI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eva Wiberg-Itzel, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Per Tornvall, professor Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP