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

NCT ID: NCT04649593

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-02-28

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

Detailed Description

Primary question: whether high AFL values (>12mmol/l) in women with observed dystocic labor are best treated by

1. to handle childbirth according to the clinic's current guidelines in case of labor dystocia, i.e. with oxytocin stimulation

2. an intake of bicarbonate (Samarin) dissolved in water given 1 hour before the oxytocin is started Primary outcome variable A comparison of the frequency of spontaneous vaginal delivery in the observed two described intervention groups.

Conditions

Dystocia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

according to clinical guidlines

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

intevention

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.

Group Type: EXPERIMENTAL

Samarin

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Samarin

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Eva Wiberg-Itzel

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eva Wiberg-Itzel

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

GB1

Identifier Type: -

Identifier Source: org_study_id