LaborNCT02396563
Effect of Epidural Analgesia on the Length of Labor and Delivery and Fetal Outcomes
An observational study of Labor and Epidural Analgesia, run by University of Cagliari.
Trial summary
The purpose of this study is to determine if there is a difference in the duration of the first and second stage of labor in nulliparous women , with or without epidural analgesia. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labor, Epidural Analgesia, Nulliparous
- What is being tested?
- epidural analgesia and Ropivacaine
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2017
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who come to the Gynecological nd obstetric Department of University Hospital to deliver
Who may be able to join
- Nulliparous
- > 18 years old
- term (>37 weeks gestation)
- singleton
- vertex pregnancies
Who cannot join
- Non-vertex presentation
- cervical dilation > 4.0cm
About this study
The purpose of this study is to determine if there is a difference in the duration of the first and second stage of labor in nulliparous women , with or without epidural analgesia. The investigators hypothesize that the duration of the first stage of labor will be no different in nulliparous patients, while the duration of the second stage will be longer in patient with analgesia.
- Conditions
- Labor, Epidural Analgesia, Nulliparous
- Being tested
- epidural analgesia, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural analgesiaProcedure or surgery
RopivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| epidural analgesia | women in labor with epidural analgesia Receives: Procedure: epidural analgesia; Drug: Ropivacaine | |
| no epidural analgesia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of labor
Measured: Onset of contractions or rupture of membrances to delivery
Secondary outcomes (2)
Presence or absence of fetal heart rate decelerations
Measured: Time of first analgesic dose to 60 minutes
fetal tachycardia
Measured: Time of first analgesic dose to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaborStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Angioni, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396563
- Sponsor's protocol ID
- LABORCA
- Status last verified
- Mar 2016
- First submitted
- 11 Mar 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epidural Analgesia on the Length of Labor and Delivery and Fetal Outcomes
- ClinicalTrials.gov ID
- NCT02396563
- Acronym / sponsor ID
- LABORCA
- Conditions
- Labor, Epidural Analgesia, Nulliparous
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Mar 2015 (estimated)
- 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 purpose of this study is to determine if there is a difference in the duration of the first and second stage of labor in nulliparous women , with or without epidural analgesia. The investigators hypothesize that the duration of the first stage of labor will be no different in nulliparous patients, while the duration of the second stage will be longer in patient with analgesia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epidural analgesia | – | Procedure: epidural analgesia, Drug: Ropivacainewomen in labor with epidural analgesia |
| no epidural analgesia | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who come to the Gynecological nd obstetric Department of University Hospital to deliver
Key inclusion criteria (5 listed)
- Nulliparous
- > 18 years old
- term (>37 weeks gestation)
- singleton
- vertex pregnancies
Key exclusion criteria (2 listed)
- Non-vertex presentation
- cervical dilation > 4.0cm
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 |
|---|---|---|
| epidural analgesia | Procedure or surgery | epidural analgesia |
| Ropivacaine | Drug | epidural analgesia |
Primary outcome
duration of labor
Time frame: Onset of contractions or rupture of membrances to delivery
2 secondary outcomes
Presence or absence of fetal heart rate decelerations
Time frame: Time of first analgesic dose to 60 minutes
fetal tachycardia
Time frame: Time of first analgesic dose to 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor and Epidural Analgesia, run by University of Cagliari.
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 2 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 9 Mar 2016. 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?
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?
duration of labor (time frame: Onset of contractions or rupture of membrances to 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 9 Mar 2016.