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Bicarbonate Given During Dystocic Labor

Primary Purpose

Arrested Labor

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Treatment

About this trial

This is an interventional treatment trial for Arrested Labor focused on measuring labor dystocia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Eva Wiberg-Itzel

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

no treatment

Treatment

Arm Description

Dystocic women where no bicarbonate was given

Dystocic women where bicarbonate was ingested

Outcomes

Primary Outcome Measures

Frequency of spontaneous vaginal delivery

Secondary Outcome Measures

Full Information

NCT ID

NCT02805387

First Posted

June 13, 2016

Last Updated

June 17, 2016

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT02805387

Brief Title

Bicarbonate Given During Dystocic Labor

Official Title

Bicarbonate, a New Treatment of Labour Dystocia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arrested Labor

Keywords

labor dystocia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

no treatment

Arm Type

No Intervention

Arm Description

Dystocic women where no bicarbonate was given

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Dystocic women where bicarbonate was ingested

Intervention Type

Dietary Supplement

Intervention Name(s)

Treatment

Intervention Description

Bicarbonate was ingested

Primary Outcome Measure Information:

Title

Frequency of spontaneous vaginal delivery

Time Frame

during labor

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Per Tornvall, professor

Organizational Affiliation

Karolinska Institutet

Official's Role

Study Chair

Facility Information:

Facility Name

Eva Wiberg-Itzel

City

Stockholm

ZIP/Postal Code

18239

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

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Bicarbonate Given During Dystocic Labor

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