Labour DystociaNCT03650972
Implementation of AFL Monitoring in Clinical Use
A study testing Samarin in people with Labour Dystocia, run by Turku University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Dystocia
- What is being tested?
- Samarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Implementation of AFL Monitoring in Clinical (Lapsiveden Laktaattipitoisuuden Merkitys kliinisessä käytössä)
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.
Read more
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:
- 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
- Being tested
- Samarin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamarinOther
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.
| Study group | Role | What they receive |
|---|---|---|
| A, Non-bicarbonate | No intervention | 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 |
| B, Bicarbonate group | Active comparator | 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. Receives: Other: Samarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneus Vaginal delivery
Measured: by the end of the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start15 Sep 2018 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour DystociaStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Susanna Koski, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650972
- Sponsor's protocol ID
- T194/2018
- Status last verified
- Aug 2018
- First submitted
- 27 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of AFL Monitoring in Clinical (Lapsiveden Laktaattipitoisuuden Merkitys kliinisessä käytössä)
- ClinicalTrials.gov ID
- NCT03650972
- Acronym / sponsor ID
- T194/2018
- Conditions
- Labour Dystocia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 15 Sep 2018 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, Non-bicarbonate | No intervention | –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 |
| B, Bicarbonate group | Active comparator | Other: SamarinWhen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamarinArm: 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. | Other | B, Bicarbonate group |
Primary outcome
Spontaneus Vaginal delivery
Time frame: by the end of the delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Labour Dystocia
Not yet recruiting
Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Labour Dystocia
Not yet recruiting
Efficacy of Bicarbonate on the Risk of Assisted Delivery in Nulliparous Women With Prolonged Labour
Prolonged Labor, Labor Dystocia
Recruiting
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Labor Dystocia, Labor Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Samarin in people with Labour Dystocia, run by Turku University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanna Koski (+358408395362, sskosk@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneus Vaginal delivery (time frame: by the end of the delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.