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The Study of Giving Birth, a Study About Treatment of Labor Dystocia

NCT04649593 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2022-03-31

No results posted yet for this study

Summary

Labor dystocia is an intransigent, high-profile issue in obstetric care, which causes significant maternal morbidity in low resource settings and maternal dissatisfaction, and increased healthcare costs worldwide. Amniotic fluid lactate, (AFL), values have recently been shown to reflect the metabolic status of the uterus and high levels have a strong association with subsequent need for operative intervention due to dystocia. In sports medicine, it is known that lactic acid can affect muscular performance but be decreased by bicarbonate given orally before physical activity. Main Outcome Measures: If an intake of bicarbonate, one hour before stimulation with oxytocin in cases with a high AFL value, changes the AFL levels and enhances delivery outcome in dystocic deliveries.

Design: Randomized controlled trial

Conditions

  • Dystocia

Interventions

DIETARY_SUPPLEMENT

Samarin

Half of the group with a high AFL value will have a glass of Samarin to drink

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-12-30
Completion
2022-02-28

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04649593 on ClinicalTrials.gov