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CompletedNCT02805387Updated Jun 20, 2016

Bicarbonate Given During Dystocic Labor

An interventional study of Treatment in Arrested Labor, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to female participants. Per ClinicalTrials.gov, last updated 2016-06-20.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
Female
01

Study summary

Dystocic deliveries and the use of bicarbonate

Read the 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.

02

Conditions studied

  • Arrested Labor

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Keywords

  • labor dystocia
03

In context

Dystocia

67 studies on the registry are indexed under Dystocia; 13 are open to participants now.

This study's enrollment of 200 is close to the median of 200 across 52 interventional studies indexed under Dystocia.

Browse Dystocia studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,146 studies on the registry; 275 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • No intervention
    no treatment

    Dystocic women where no bicarbonate was given

  • Experimental
    Treatment

    Dystocic women where bicarbonate was ingested

    Dietary Supplement: Treatment

Interventions

  • Dietary supplementTreatment

    Bicarbonate was ingested

06

What researchers measure

Primary outcomes

  1. Frequency of spontaneous vaginal delivery

    Time frame: during labor

07

Study locations

1 site
  • Eva Wiberg-Itzel
    Stockholm, 18239, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02805387
Responsible party
Eva Wiberg-Itzel (Associate professor, Senior lecturer, Karolinska Institutet) — Principal investigator
First posted
Jun 20, 2016
Start date
Jan 2013
Primary completion
Dec 2014
Completion
Jun 2015
Last update
Jun 20, 2016

Study contacts

Per Tornvall, professor
study chair · Karolinska Institutet

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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