NCT04649593

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

The Giving Birth Project, a Study of Labor Dystocia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Samarin	Half of the group with a high AFL value will have a glass of Samarin to drink

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-12-30
• Completion: 2022-02-28
• First posted: 2020-12-02
• Last updated: 2022-03-31

Locations

1 site across 1 country: Sweden