An interventional study of Samarin in Dystocia, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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
Primary question: whether high AFL values (>12mmol/l) in women with observed dystocic labor are best treated by
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's enrollment of 2,000 is above the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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Exclusion Criteria:
Dystocic progress and an observed low AFL value (\< 12.0 mmol/l).
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
Half of the group with a high AFL value will have a glass of Samarin to drink
Labor outcome
Labor outcome in the different groups (spontaneous vaginal, VE or caesarean section)
Time frame: through study completion, an average of 1 year
AFL values
AFL-values to be at different times during labor
Time frame: through study completion, an average of 1 year
The use of oxytocin
Oxytocin stimulation (number of hours of stimulation and amount of oxytocin given),
Time frame: through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2020 to primary completion in Dec 2021, 23 months.
Of 18 interventional studies with no phase under Dystocia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 40. This study's 23 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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