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

Study Overview
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Brief Summary
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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
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Primary question: whether high AFL values (>12mmol/l) in women with observed dystocic labor are best treated by to handle childbirth according to the clinic's current guidelines in case of labor dystocia, i.e. with oxytocin stimulation 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.

Official Title
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The Giving Birth Project, a Study of Labor Dystocia

Conditions
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Dystocia

Intervention / Treatment
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* Dietary Supplement: Samarin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: according to clinical guidlines<br>Dystocic progress and an observed low AFL value (< 12.0 mmol/l). | |
| Experimental: intevention<br>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<br>* Half of the group with a high AFL value will have a glass of Samarin to drink<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The use of oxytocin | Oxytocin stimulation (number of hours of stimulation and amount of oxytocin given), | through study completion, an average of 1 year |