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Completed

NCT Number: NCT04649593

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

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

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Key information

Conditions

Dystocia Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eva Wiberg-Itzel

Stockholm, 18239, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Samarin

Dietary Supplement

Half of the group with a high AFL value will have a glass of Samarin to drink

Primary outcomes

  1. Labor outcome

    Time frame: through study completion, an average of 1 year

    Labor outcome in the different groups (spontaneous vaginal, VE or caesarean section)

  2. AFL values

    Time frame: through study completion, an average of 1 year

    AFL-values to be at different times during labor

Secondary outcomes

  1. The use of oxytocin

    Time frame: through study completion, an average of 1 year

    Oxytocin stimulation (number of hours of stimulation and amount of oxytocin given),

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

The Giving Birth Project, a Study of Labor Dystocia

Acronym: GB

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 2, 2020
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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