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Bicarbonate Given During Dystocic Labor

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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

Brief Summary:
Dystocic deliveries and the use of bicarbonate

Condition or disease Intervention/treatment Phase
Arrested Labor Dietary Supplement: Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bicarbonate, a New Treatment of Labour Dystocia
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015

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




Primary Outcome Measures :
  1. Frequency of spontaneous vaginal delivery [ Time Frame: during labor ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805387


Locations
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Sweden
Eva Wiberg-Itzel
Stockholm, Sweden, 18239
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Study Chair: Per Tornvall, professor Karolinska Institutet
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Responsible Party: Eva Wiberg-Itzel, Associate professor, Senior lecturer, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02805387    
Other Study ID Numbers: KI
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eva Wiberg-Itzel, Karolinska Institutet:
labor dystocia
Additional relevant MeSH terms:
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Dystocia
Heart Arrest
Obstetric Labor Complications
Pregnancy Complications
Heart Diseases
Cardiovascular Diseases