Birth Outcome, AdverseNCT06420453
How Long Can Labor Last? Person Centred Care During Labor to Increase Safety for Women and Newborn
An observational study of Birth Outcome, Adverse and Labor Long, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
"How long will my labor last" is a very common question for midwives who care for women during birth. To evaluate safe labor duration largely determines management and care during birth. Today a standardized tool is used by midwives to evaluate normal and safe labor called the partograph. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Birth Outcome, Adverse, Labor Long, Labor Complication
- How many people
- 300,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2008to 31 Aug 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is an epidemiological research project using the largest cohort in the world containing detailed information on labor progression and care during labor. The cohort used is built from detailed data from medical records in the Stockholm-Gotland Obstetric Cohort, including all births from 2008 to 2020 (> 300 000 births). This includes data from the partograph with information about start of labor, all cervical examinations, care interventions, total duration of labor, maternal and neonatal outcomes. For completeness of data on infant outcomes, the cohort has been linked with the Swedish Neonatal Quality Register (SNQ).
Who may be able to join
- All births with labor duration
Who cannot join
- Elective Cesarean birth
Trial locations and contacts
1 site in 1 country.
About this study
"How long will my labor last" is a very common question for midwives who care for women during birth. To evaluate safe labor duration largely determines management and care during birth. Today a standardized tool is used by midwives to evaluate normal and safe labor called the partograph. The World Health Organization partograph is a decision-making support tool designed to assist midwives in identifying normal labor duration and women at risk of developing complications. The tool guide the use of care interventions intended to mitigate any perceived risks. The partograph has been in use since the 1950ies and has had a profound impact on care and management during labor. Normal labor progression according to the partograph is a linear progression with cervical dilation of 1 centimeter per hour (alert line) and any deviation from this should lead to an intervention.The purpose of this research project is to increase person-centred care during labor. Specifically, we want to provide updated comprehensive information on labor duration and patient safety for reduction of; unnecessary medical interventions during normal labor; morbidity and mortality in the new-born; maternal complications during delivery and the puerperal period.
- Conditions
- Birth Outcome, Adverse, Labor Long, Labor Complication, Maternal Injury, Maternal Distress During Labor and Delivery, Neonatal and Perinatal Conditions
- Medical subject headings
- Pregnancy Complications, Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed to prolonged labor duration | Not described | |
| Not exposed to prolonged labor duration | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse neonatal outcomes
Measured: 1 month postpartum
Adverse maternal outcomes
Measured: 1 month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Jan 2008
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth Outcome, AdverseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300,000 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Mia Ahlberg, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420453
- Sponsor's protocol ID
- 2023-02010
- Other IDs
- 2023
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- 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 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Long Can Labor Last? Person Centred Care During Labor to Increase Safety for Women and Newborn
- ClinicalTrials.gov ID
- NCT06420453
- Acronym / sponsor ID
- 2023-02010
- Conditions
- Birth Outcome, Adverse, Labor Long, Labor Complication, Maternal Injury, Maternal Distress During Labor and Delivery, Neonatal and Perinatal Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300,000 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 20 May 2024 (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.
"How long will my labor last" is a very common question for midwives who care for women during birth. To evaluate safe labor duration largely determines management and care during birth. Today a standardized tool is used by midwives to evaluate normal and safe labor called the partograph. The World Health Organization partograph is a decision-making support tool designed to assist midwives in identifying normal labor duration and women at risk of developing complications. The tool guide the use of care interventions intended to mitigate any perceived risks. The partograph has been in use since the 1950ies and has had a profound impact on care and management during labor. Normal labor progression according to the partograph is a linear progression with cervical dilation of 1 centimeter per hour (alert line) and any deviation from this should lead to an intervention.The purpose of this research project is to increase person-centred care during labor. Specifically, we want to provide updated comprehensive information on labor duration and patient safety for reduction of; unnecessary medical interventions during normal labor; morbidity and mortality in the new-born; maternal complications during delivery and the puerperal period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed to prolonged labor duration | – | – |
| Not exposed to prolonged labor duration | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is an epidemiological research project using the largest cohort in the world containing detailed information on labor progression and care during labor. The cohort used is built from detailed data from medical records in the Stockholm-Gotland Obstetric Cohort, including all births from 2008 to 2020 (> 300 000 births). This includes data from the partograph with information about start of labor, all cervical examinations, care interventions, total duration of labor, maternal and neonatal outcomes. For completeness of data on infant outcomes, the cohort has been linked with the Swedish Neonatal Quality Register (SNQ).
Key inclusion criteria (1 listed)
- All births with labor duration
Key exclusion criteria (1 listed)
- Elective Cesarean birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse neonatal outcomes
Time frame: 1 month postpartum
Adverse maternal outcomes
Time frame: 1 month postpartum
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 20 May 2024.
- Individual participant dataSharing planned: No
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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?
An observational study of Birth Outcome, Adverse and Labor Long, 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 1 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 20 May 2024. 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?
Adverse neonatal outcomes (time frame: 1 month postpartum). 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 20 May 2024.