Back to results

The Study of Giving Birth, a Study About Treatment of Labor Dystocia (GB)

Primary Purpose

Dystocia

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Samarin

About this trial

This is an interventional treatment trial for Dystocia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Eva Wiberg-Itzel

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

according to clinical guidlines

intevention

Arm Description

Dystocic progress and an observed low AFL value (< 12.0 mmol/l).

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.

Outcomes

Primary Outcome Measures

Labor outcome

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

AFL values

AFL-values to be at different times during labor

Secondary Outcome Measures

The use of oxytocin

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

Full Information

NCT ID

NCT04649593

First Posted

November 22, 2020

Last Updated

March 28, 2022

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT04649593

Brief Title

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

Acronym

Official Title

The Giving Birth Project, a Study of Labor Dystocia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

December 30, 2021 (Actual)

Study Completion Date

February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

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

Dystocia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

2000 (Actual)

8. Arms, Groups, and Interventions

Arm Title

according to clinical guidlines

Arm Type

No Intervention

Arm Description

Dystocic progress and an observed low AFL value (< 12.0 mmol/l).

Arm Title

intevention

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Samarin

Intervention Description

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

Primary Outcome Measure Information:

Title

Labor outcome

Description

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

Time Frame

through study completion, an average of 1 year

Title

AFL values

Description

AFL-values to be at different times during labor

Time Frame

through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

The use of oxytocin

Description

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

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

The study is about labor. It means only women is the possible inclusion

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Eva Wiberg-Itzel

City

Stockholm

ZIP/Postal Code

18239

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs