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

NCT04649593 | Completed DMC

• 1 other identifier: GB1
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Labor outcome

  Labor outcome in the different groups (spontaneous vaginal, VE or caesarean section)

  through study completion, an average of 1 year

• AFL values

  AFL-values to be at different times during labor

  through study completion, an average of 1 year

Secondary Outcomes (1)

• The use of oxytocin

  through study completion, an average of 1 year

Study Arms (2)

according to clinical guidlines

NO INTERVENTION

Dystocic progress and an observed low AFL value (\< 12.0 mmol/l).

intevention

EXPERIMENTAL

At dystocic labor and an observed high AFL value, the woman is randomized to one of the intended two study groups. Group 1) Delivery according to the clinic's guidelines in case labor dystocia, i.e., oxytocin stimulation Group 2) Two bags of Samarin mixed in a glass of water. After an hour, In case of lack of progress, oxytocin stimulation is started.

Dietary Supplement: Samarin

Interventions

Samarin DIETARY_SUPPLEMENT

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

intevention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study is about labor. It means only women is the possible inclusion
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• dystocic labor with a need of oxytocin \>=34w of gestation

You may not qualify if:

• Nondystocic labors.
• Women who don't understand Swedish or English
• Premature deliveries (\<34w)

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Eva Wiberg-Itzel

Stockholm, 18239, Sweden

Location

MeSH Terms

Conditions

Dystocia

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

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

Model Details: According to the clinic's memo, when the labor is found to be dystocic, the woman is asked about her participation in the study. If the woman admits participation, she is included in the project. This is also noted in her journal.

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: December 2, 2020
• Study Start: January 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: February 28, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)