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

Not Applicable

Completed

• Conditions: Dystocia
• Interventions: Dietary Supplement: Samarin

• Registration Number: NCT04649593
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-11-22
• Study First Submitted QC: 2020-11-25
• Study First Posted: 2020-12-02
• Primary Completion: 2021-12-30
• Study Completion: 2022-02-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intevention	Samarin	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.

Primary Outcome Measures

Name	Time	Method
Labor outcome	through study completion, an average of 1 year	Labor outcome in the different groups (spontaneous vaginal, VE or caesarean section)
AFL values	through study completion, an average of 1 year	AFL-values to be at different times during labor

Secondary Outcome Measures

Name	Time	Method
The use of oxytocin	through study completion, an average of 1 year	Oxytocin stimulation (number of hours of stimulation and amount of oxytocin given),

Trial Locations

Locations (1)

Eva Wiberg-Itzel; 🇸🇪 Stockholm, Sweden