Implementation of AFL Monitoring in Clinical Use

NCT ID: NCT03650972

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-15
• Study Completion Date: 2020-12-31

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

Conditions

Labour Dystocia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

A, Non-bicarbonate

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Samarin

Intervention Type: OTHER

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.

Interventions

Samarin

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Susanna Koski

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Susanna Koski

Role: CONTACT

sskosk@utu.fi

+358408395362

Other Identifiers

T194/2018

Identifier Type: -

Identifier Source: org_study_id