NCT02805387

Brief Summary

Dystocic deliveries and the use of bicarbonate

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

1.9 years

First QC Date

June 13, 2016

Last Update Submit

June 17, 2016

Conditions

Arrested Labor

Keywords

labor dystocia

Outcome Measures

Primary Outcomes (1)

  • Frequency of spontaneous vaginal delivery

    during labor

Study Arms (2)

no treatment

NO INTERVENTION

Dystocic women where no bicarbonate was given

Treatment

EXPERIMENTAL

Dystocic women where bicarbonate was ingested

Dietary Supplement: Treatment

Interventions

TreatmentDIETARY_SUPPLEMENT

Bicarbonate was ingested

Treatment

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eva Wiberg-Itzel

Stockholm, 18239, Sweden

Location

MeSH Terms

Conditions

Dystocia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Per Tornvall, professor

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Senior lecturer

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 20, 2016

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

June 20, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)