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Implementation of AFL Monitoring in Clinical Use

Primary Purpose

Labour Dystocia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Samarin
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labour Dystocia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • gestational age at least 37 + 0 weeks
  • singleton pregnancy
  • cephalic presentation
  • active labor (regular painful contractions, effaced cervix open at least 3cm)
  • arrested labour progress according partogram and clinic guidelines

Exclusion Criteria:

  • intra uterine fetal growth retardation (> 22%)
  • intra uterine fetal death
  • threat of fetal asphyxia
  • severe vaginal bleeding
  • disproportion between the fetal head and the mother's pelvis
  • hypertonic contractions (more than 5 in 10 minutes)
  • known allergy or hypersensitivity to oxytocin or to any of derivatives
  • women who cannot understand the information of the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    A, Non-bicarbonate

    B, Bicarbonate group

    Arm Description

    When labour arrest is diagnosed and the first AFL > 12 mmol/L the participants will be randomized to two groups. In group A the labour is treated according to the hospital's current guidelines during labour arrest, i.e. the stimulation with oxytocin is started and AFL is measured again after one hour

    When labour arrest is diagnosed and the first AFL > 12 mmol/L the participants will be randomized to two groups. In group B the participant will drink bicarbonate (2 packages of Samarin®) dissolved in 200 ml of water. Then after one hour the AFL will be measured again and the stimulation with oxytocin will be started if there is no progress in the cervix.

    Outcomes

    Primary Outcome Measures

    Spontaneus Vaginal delivery

    Secondary Outcome Measures

    Full Information

    First Posted
    August 27, 2018
    Last Updated
    August 27, 2018
    Sponsor
    Turku University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03650972
    Brief Title
    Implementation of AFL Monitoring in Clinical Use
    Official Title
    Implementation of AFL Monitoring in Clinical (Lapsiveden Laktaattipitoisuuden Merkitys kliinisessä käytössä)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 15, 2018 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Turku University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The overall objective of this randomized controlled trial is to develop a clinical standard procedure for measuring lactate in amniotic fluid (amniotic fluid lactate = = AFL) during childbirth before oxytocin stimulation is started. The aim is to reduce the need for emergency caesarean section during dysfunctional labour. The aim is also to study how different substances (oxytocin and Samarin®) affect uterine metabolic status during labour. Labour dystocia, i.e. prolonged labour, occurs in up to 30% in primipara deliveries and in about 20% of all the deliveries. In 2016, in Finland oxytocin stimulation was used in 42% of all the deliveries. The uterus, myometrium, is one of the largest muscles in the human body and consists mainly of smooth muscle cells. During the contractions the myometrial vessels also contract, causing momentary hypoxia and activation of anaerobic metabolism: O2 and pH levels of the muscle cell decreases and the lactate concentration increases. After the contraction, the blood circulation is restored and the anaerobic metabolites gradually dissolve. Myometrium requires a sufficiently long break between the contractions to recover. In dysfunctional labour the anaerobic metabolites accumulate in the myometrium. Accumulation of lactate has proved significantly to reduce the spontaneous contractions of myometrium and hinder myometrium calcium metabolism, which in turn reduces the strength of the contractions. Amniotic fluid lactate is known to reflect the metabolic state of the uterus during the labour. Prolonged labour can in many aspects be compared to the athlete's tired muscles. Many of today's athletes try to control the accumulation of lactic acid in their muscles during training by drinking baking soda (bicarbonate) dissolved in water one hour before their physical activity. Bicarbonate is known to function as a lactic acid buffer. Bicarbonate is considered as food and is sold in grocery stores as baking soda and for example as Samarin®. Samarin® is safe to use during pregnancy because as a bicarbonate it does not pass through placenta and does not affect the fetus. The trial aims to research if high AFL values (AFL > 12 mmol/L) in women with labour arrest are best treated by: A) treating the labour according to the hospital's current guidelines during labour arrest, i.e. starting the stimulation with oxytocin and measuring the AFL again after one hour B) administering bicarbonate (Samarin®) dissolved in water one hour before starting the stimulation with oxytocin

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labour Dystocia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A, Non-bicarbonate
    Arm Type
    No Intervention
    Arm Description
    When labour arrest is diagnosed and the first AFL > 12 mmol/L the participants will be randomized to two groups. In group A the labour is treated according to the hospital's current guidelines during labour arrest, i.e. the stimulation with oxytocin is started and AFL is measured again after one hour
    Arm Title
    B, Bicarbonate group
    Arm Type
    Active Comparator
    Arm Description
    When labour arrest is diagnosed and the first AFL > 12 mmol/L the participants will be randomized to two groups. In group B the participant will drink bicarbonate (2 packages of Samarin®) dissolved in 200 ml of water. Then after one hour the AFL will be measured again and the stimulation with oxytocin will be started if there is no progress in the cervix.
    Intervention Type
    Other
    Intervention Name(s)
    Samarin
    Intervention Description
    Arm: Active Comparator: B, Bicarbonate group When labour arrest is diagnosed and the first AFL > 12 mmol/L the participants will be randomized to two groups. In group B the participant will drink bicarbonate (2 packages of Samarin®) dissolved in 200 ml of water. Then after one hour the AFL will be measured again and the stimulation with oxytocin will be started if there is no progress in the cervix.
    Primary Outcome Measure Information:
    Title
    Spontaneus Vaginal delivery
    Time Frame
    by the end of the delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: gestational age at least 37 + 0 weeks singleton pregnancy cephalic presentation active labor (regular painful contractions, effaced cervix open at least 3cm) arrested labour progress according partogram and clinic guidelines Exclusion Criteria: intra uterine fetal growth retardation (> 22%) intra uterine fetal death threat of fetal asphyxia severe vaginal bleeding disproportion between the fetal head and the mother's pelvis hypertonic contractions (more than 5 in 10 minutes) known allergy or hypersensitivity to oxytocin or to any of derivatives women who cannot understand the information of the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Susanna Koski
    Phone
    +358408395362
    Email
    sskosk@utu.fi

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Implementation of AFL Monitoring in Clinical Use

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