Trial of Labor After CesareanTOLACNCT07549971
Trial of Labor After One Cesarean Section a Cross-sectional Study After Protocol Introduction
An observational study of Trial of Labor After Cesarean and Trial of Labor; Failure, run by G. d'Annunzio University.
Trial summary
in 2015 a protocol for trail of labor after a single cesarean delivery was approved by medical committee of Pescara Hospital. A database from outpatient clinic evaluated all women after 34 weeks' gestation with a previous cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 57 years, women only
- Conditions the study is for
- Trial of Labor After Cesarean, Trial of Labor; Failure
- What is being tested?
- repetitive elective CD
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jan 2026
- 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 57 years
- Women only
- No healthy volunteers
- Adult
Study population: All prengnat women attending labor ward of Santo Spirito Hospital of Pescara (Italy)
Who may be able to join
- pregnant women
- previous CD
Who cannot join
- below 34 weeks' gestation
- medical indication to CD
About this study
Official title: Trial of Labor After Cesarean
in 2015 a protocol for trail of labor after a single cesarean delivery was approved by medical committee of Pescara Hospital. A database from outpatient clinic evaluated all women after 34 weeks' gestation with a previous cesarean delivery. Patients with a specific medical indication for cesarean delivery were skipped, whilst the others were recruited within repetitive elective cesarean delivery or trial of labor based on maternal request. Patients were couselled on the opportunity of having a mechanical induction/ rupture of membranes and subsequent oxytocin infusion if needed due to prolonged gestation (above 41 weeks plus 3 days) or medical indication to delivery (i.e. gestational diabetes, hypertension, SGA, etc.)
Read the detailed description
All pregnant women with a previous CD attending Labor Ward of Santo Spirito Hospital of Pescara Italy (affiliated to University of Chieti Pescara) were enrolled at outpatient clinic after internal protocol registration for trial of labor in previus cesarean delivery. Patinets with a medical indication to CD were not elegible. Sociodemographic data such as ethnic background, maternal age, gestational age at delivery, previous vaginal birth, indications to previous CD, and maternal willingness to RECD ot TOLAC were recorded.
Maternal decision to switch to different intervention were recorded. Outcome of RECD and TOLAC were recorded.
- Being tested
- repetitive elective CD
- Keywords
- trial of labor after cesarean, failure of labor, induction of labor after cesarean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive elective CDProcedure or surgery
maternal and neonatal outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of maternal request for trial of labor
incidence of women with request of trial of labor through the time
Measured: 11 years
incidence of VBAC
number of vaginal birth through the time
Measured: 11 years
Secondary outcomes (2)
maternal adverse outcome
maternal adverse outcome such as PPH, emergency CS, surgical complications
Measured: 11 years
neonatal adverse outcome
NICU stay, low APGAR score (<7 at 5'), fetal death
Measured: 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Jan 2015
- Primary completion31 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trial of Labor After CesareanStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Celentano, G. d'Annunzio University
- Investigators
- Claudio Celentano, MD, Principal investigator, University of Chieti Pescara School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549971
- Sponsor's protocol ID
- ObGynEASC010
- Other IDs
- ASL register
- Acronym
- TOLAC
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: depends on the request
Publications
Benetti CMS, Muhandule CJLS, Fogulin LB, Machado HDC, Amaral E. Cesarean delivery on maternal request and Robson classification. Int J Gynaecol Obstet. 2026 Jul;174(1):347-352. doi: 10.1002/ijgo.70841. Epub 2026 Feb 2.
PubMed 41626770
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Labor After Cesarean
- ClinicalTrials.gov ID
- NCT07549971
- Acronym / sponsor ID
- TOLAC / ObGynEASC010
- Keywords
- trial of labor after cesarean, failure of labor, induction of labor after cesarean
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 24 Apr 2026 (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.
in 2015 a protocol for trail of labor after a single cesarean delivery was approved by medical committee of Pescara Hospital. A database from outpatient clinic evaluated all women after 34 weeks' gestation with a previous cesarean delivery. Patients with a specific medical indication for cesarean delivery were skipped, whilst the others were recruited within repetitive elective cesarean delivery or trial of labor based on maternal request. Patients were couselled on the opportunity of having a mechanical induction/ rupture of membranes and subsequent oxytocin infusion if needed due to prolonged gestation (above 41 weeks plus 3 days) or medical indication to delivery (i.e. gestational diabetes, hypertension, SGA, etc.)
Detailed description
All pregnant women with a previous CD attending Labor Ward of Santo Spirito Hospital of Pescara Italy (affiliated to University of Chieti Pescara) were enrolled at outpatient clinic after internal protocol registration for trial of labor in previus cesarean delivery. Patinets with a medical indication to CD were not elegible. Sociodemographic data such as ethnic background, maternal age, gestational age at delivery, previous vaginal birth, indications to previous CD, and maternal willingness to RECD ot TOLAC were recorded.
Maternal decision to switch to different intervention were recorded. Outcome of RECD and TOLAC were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 57 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All prengnat women attending labor ward of Santo Spirito Hospital of Pescara (Italy)
Key inclusion criteria (2 listed)
- pregnant women
- previous CD
Key exclusion criteria (2 listed)
- below 34 weeks' gestation
- medical indication to CD
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 |
|---|---|---|
| repetitive elective CDmaternal and neonatal outcomes | Procedure or surgery | – |
Primary outcome
incidence of maternal request for trial of labor
Time frame: 11 years
incidence of women with request of trial of labor through the time
incidence of VBAC
Time frame: 11 years
number of vaginal birth through the time
2 secondary outcomes
maternal adverse outcome
Time frame: 11 years
neonatal adverse outcome
Time frame: 11 years
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 24 Apr 2026.
- Results publication: PubMed 41626770Benetti CMS, Muhandule CJLS, Fogulin LB, Machado HDC, Amaral E. Cesarean delivery on maternal request and Robson classification. Int J Gynaecol Obstet. 2026 Jul;174(1):347-352. doi: 10.1002/ijgo.70841. Epub 2026 Feb 2.
- Individual participant dataSharing planned: Undecided. depends on the request
Related trials for Trial of Labor After Cesarean
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Evaluation of Blood Loss After Cesarean Delivery Via US Compared to Standard Care
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Role of Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Section
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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.
Claudio Celentano, MD principal investigator
University of Chieti Pescara School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Trial of Labor After Cesarean and Trial of Labor; Failure, run by G. d'Annunzio University.
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 2 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: finished, as of the sponsor's last update on 24 Apr 2026. 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?
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?
incidence of maternal request for trial of labor (time frame: 11 years). 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?
On the ClinicalTrials.gov record for NCT07549971, which also lists 1 linked publication.
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 24 Apr 2026.