Dystocia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTSamarin
Half of the group with a high AFL value will have a glass of Samarin to drink
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The use of oxytocin | through study completion, an average of 1 year | Oxytocin stimulation (number of hours of stimulation and amount of oxytocin given), |
Countries
Sweden
Outcome results
None listed