Bicarbonate Given During Dystocic Labor

Bicarbonate, a New Treatment of Labour Dystocia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02805387

Enrollment

200

Registered

2016-06-20

Start date

2013-01-31

Completion date

2015-06-30

Last updated

2016-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrested Labor

Keywords

labor 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.

Interventions

DIETARY_SUPPLEMENTTreatment

Bicarbonate was ingested

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Frequency of spontaneous vaginal delivery	during labor

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026