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

Dystocia Clinical Trial

— GB  

Official title:

The Giving Birth Project, a Study of Labor Dystocia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04649593
• Other study ID #: GB1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: February 28, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dystocia

Intervention

Dietary Supplement:
• Samarin
Half of the group with a high AFL value will have a glass of Samarin to drink

Locations

Country	Name	City	State
Sweden	Eva Wiberg-Itzel	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Labor outcome	Labor outcome in the different groups (spontaneous vaginal, VE or caesarean section)	through study completion, an average of 1 year
Primary	AFL values	AFL-values to be at different times during labor	through study completion, an average of 1 year
Secondary	The use of oxytocin	Oxytocin stimulation (number of hours of stimulation and amount of oxytocin given),	through study completion, an average of 1 year