DystociaGBNCT04649593
The Study of Giving Birth, a Study About Treatment of Labor Dystocia
A study testing Samarin in people with Dystocia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dystocia
- What is being tested?
- Samarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to 28 Feb 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dystocic labor with a need of oxytocin >=34w of gestation
Who cannot join
- Nondystocic labors.
- Women who don't understand Swedish or English
- Premature deliveries (<34w)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Giving Birth Project, a Study 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
Read the detailed description
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.
- Conditions
- Dystocia
- Being tested
- Samarin
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamarinDietary supplement
Half of the group with a high AFL value will have a glass of Samarin to drink
| Study group | Role | What they receive |
|---|---|---|
| according to clinical guidlines | No intervention | Dystocic progress and an observed low AFL value (< 12.0 mmol/l). |
| intevention | Experimental | 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. Receives: Dietary Supplement: Samarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor outcome
Labor outcome in the different groups (spontaneous vaginal, VE or caesarean section)
Measured: through study completion, an average of 1 year
AFL values
AFL-values to be at different times during labor
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
The use of oxytocin
Oxytocin stimulation (number of hours of stimulation and amount of oxytocin given),
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Jan 2020
- Primary completion30 Dec 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystociaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- According to the clinic's memo, when the labor is found to be dystocic, the woman is asked about her participation in the study. If the woman admits participation, she is included in the project. This is also noted in her journal.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Wiberg-Itzel, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649593
- Sponsor's protocol ID
- GB1
- Acronym
- GB
- Status last verified
- Mar 2022
- First submitted
- 22 Nov 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Giving Birth Project, a Study of Labor Dystocia
- ClinicalTrials.gov ID
- NCT04649593
- Acronym / sponsor ID
- GB / GB1
- Conditions
- Dystocia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 2 Dec 2020 (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.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- According to the clinic's memo, when the labor is found to be dystocic, the woman is asked about her participation in the study. If the woman admits participation, she is included in the project. This is also noted in her journal.
| Arm | Type | Receives |
|---|---|---|
| according to clinical guidlines | No intervention | –Dystocic progress and an observed low AFL value (< 12.0 mmol/l). |
| intevention | Experimental | Dietary Supplement: SamarinAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- dystocic labor with a need of oxytocin >=34w of gestation
Key exclusion criteria (3 listed)
- Nondystocic labors.
- Women who don't understand Swedish or English
- Premature deliveries (<34w)
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 |
|---|---|---|
| SamarinHalf of the group with a high AFL value will have a glass of Samarin to drink | Dietary supplement | intevention |
Primary outcome
Labor outcome
Time frame: through study completion, an average of 1 year
Labor outcome in the different groups (spontaneous vaginal, VE or caesarean section)
AFL values
Time frame: through study completion, an average of 1 year
AFL-values to be at different times during labor
1 secondary outcome
The use of oxytocin
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Dystocia
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Active, not recruiting
Calcium Carbonate on Labor Induction
Pregnancy, Uterine Contraction
Not yet recruiting
Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Labour Dystocia
RecruitingPhase 4
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Postpartum Hemorrhage, Uterine Atony
Recruiting
Maternal Maneuvers During Prolonged Labor
Labor Stage, First, Prolonged Labor
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Samarin in people with Dystocia, run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labor outcome (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 31 Mar 2022.