Bicarbonate Given During Dystocic Labor

Karolinska Institute

Status: Completed

Conditions: Arrested Labor

Treatments: Dietary Supplement: Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02805387

KI

Details and patient eligibility

About

Dystocic deliveries and the use of bicarbonate

Full 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.

Enrollment: 200 patients

Sex: Female

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

no treatment

No Intervention group

Description:

Dystocic women where no bicarbonate was given

Treatment

Experimental group

Description:

Dystocic women where bicarbonate was ingested

Treatment:

Dietary Supplement: Treatment