Cesarean Delivery Affecting Fetus or NewbornTOLA2C TrainNCT07258459
Two Previous Cesarean and Vaginal Birth Before and After Starting Training and Protocols
An observational study of Cesarean Delivery Affecting Fetus or Newborn and Labor (Obstetrics)--Complications, run by G. d'Annunzio University at 2 sites in Italy.
Trial summary
In 2015 ObGyn Dept of Santo Spirito Hospital in Pescara (Italy) started protocol for previous CS vaginal birth. In 2021 was started a protocol for training on obstetric emergencies and protocol on two previous cesarean was endorsed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Delivery Affecting Fetus or Newborn, Labor (Obstetrics)--Complications, Hemorrhagic Complications
- What is being tested?
- Acceptance, rate of vaginal birth and safety
- Type of treatment
- Surgery or procedure
- How many people
- 2,016 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2016to 1 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: pregnant women attending birth in Santo Spirito Hospital Pescara (Italy) from 01-01-2016 to 31-12-2025
Who may be able to join
- pregnant women
- pregnancy above 34 weeks' gestation
- cephalic presentation of the fetus
- singleton and twins
- diamniotic twins
- 2 previous CS
- more than 18 months from last CS
- no other indication to CS
Who cannot join
- pregnancy below 34 weeks' gestation
- breech baby
- triplets or high order multiple pregnancies
- more than 2 previous CS
- less than 18 months from last CS
- precence of other indications to CS (i.e. maternal diseases, placenta previa, etc.)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Claudio Celentano
Pescara, PE, 65100
Claudio Celentano, MD, +393285577305, celentanoclaudio70@gmail.com
- Recruiting
Santo Spirito Hospital
Pescara, PE, 65123
Maurizio Rosati, MD, +39 085 4252247, claudio.celentano@ausl.pe.it
About this study
Official title: Trial of Labor After Two CS Before and After Training a Protocol Introduction
In 2015 ObGyn Dept of Santo Spirito Hospital in Pescara (Italy) started protocol for previous CS vaginal birth. In 2021 was started a protocol for training on obstetric emergencies and protocol on two previous cesarean was endorsed. Patients attending birth in Pescara with two previous from january 2016 to December 2020, and from january 2021 to december 2025 were collected. A different counseling approach was adopted from 2021. Women's acceptance of trial of labor and maternal and fetal outcomes were collected.
Read the detailed description
Women attending birth in Santo Spirito Hospital with 2 previous CS were collected.
Exclusion Criteria:
- Patients with clinical indication to CS
- a previous CS less than 18 month before
- breech presentations
- triplets
- premature labor before 34 completed weeks' gestation The first period was starting January 1st 2016 to December 31st 2020. The second period was starting January 1st 2021 to December 31st 2025
Primary outcomes:
- incidence of trial of labor acceptance
- incidence of vaginal birth
Secondary outcomes:
- maternal adverse outcomes (PPH, blood transfusion, vaginal tears, hysterectomy, maternal death)
- fetal adverse outcomes (fetal death, NICU stay, APGAR score less than 7 at 5')
- Conditions
- Cesarean Delivery Affecting Fetus or Newborn, Labor (Obstetrics)--Complications, Hemorrhagic Complications
- Being tested
- Acceptance, rate of vaginal birth and safety
- Keywords
- previous CS, trial of labor, maternal outcomes, fetal outcomes, neonatal outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance, rate of vaginal birth and safetyProcedure or surgery
In 2021 started a new delivery protocol enhancing the opportunity of having a trial of labor in women with a history of two previous CS. Rate of acceptance, rate of successful vaginal birth, maternal and fetal outcomes were evaluated
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | term pregnant women with 2 previous CS from 01.01.2021 to 31.12.2025 Receives: Procedure: Acceptance, rate of vaginal birth and safety | |
| Group 1 | Women with a history of two previous CS in period 01.01.2026 - 31-12.2020 Receives: Procedure: Acceptance, rate of vaginal birth and safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
vaginal birth after 2 cesarean
Incidence of patients having a vaginal birth after 2 CS
Measured: 5 years
accepted indication to trial of labor
incidence of women accepting indication to trial of labor
Measured: 5 years
Secondary outcomes (3)
emergency CS
incidence of emergency CS
Measured: 5 years
maternal outcomes
incidence of adverse maternal outcomes (PPH, blood transfusion, vaginal tears, hysterectomy)
Measured: 5 years
Fetal and Neonatal adverse outcomes
Incidence of fetal/neonatal death, NICU stay, APGAR score below 7 at 5'
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Jan 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
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 Cesarean Delivery Affecting Fetus or NewbornStudies 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
- 2,016 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258459
- Sponsor's protocol ID
- ObGynEASC009
- Acronym
- TOLA2C Train
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brandstetter M, Brandstetter A, Kainz-Schultes S, Jacobs VR, Fazelnia C, Fischer T, Bogner G. Successful Trial of Labor After Two Caesarean Sections (TOLA2C): Analysis of a Delivery Protocol with Feto-Maternal Outcome. Geburtshilfe Frauenheilkd. 2025 Feb 7;85(8):862-869. doi: 10.1055/a-2513-6562. eCollection 2025 Aug.
PubMed 40771829
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Labor After Two CS Before and After Training a Protocol Introduction
- ClinicalTrials.gov ID
- NCT07258459
- Acronym / sponsor ID
- TOLA2C Train / ObGynEASC009
- Conditions
- Cesarean Delivery Affecting Fetus or Newborn, Labor (Obstetrics)--Complications, Hemorrhagic Complications
- Keywords
- previous CS, trial of labor, maternal outcomes, fetal outcomes, neonatal outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,016 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 2 Dec 2025 (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 ObGyn Dept of Santo Spirito Hospital in Pescara (Italy) started protocol for previous CS vaginal birth. In 2021 was started a protocol for training on obstetric emergencies and protocol on two previous cesarean was endorsed. Patients attending birth in Pescara with two previous from january 2016 to December 2020, and from january 2021 to december 2025 were collected. A different counseling approach was adopted from 2021. Women's acceptance of trial of labor and maternal and fetal outcomes were collected.
Detailed description
Women attending birth in Santo Spirito Hospital with 2 previous CS were collected.
Exclusion Criteria:
- Patients with clinical indication to CS
- a previous CS less than 18 month before
- breech presentations
- triplets
- premature labor before 34 completed weeks' gestation The first period was starting January 1st 2016 to December 31st 2020. The second period was starting January 1st 2021 to December 31st 2025
Primary outcomes:
- incidence of trial of labor acceptance
- incidence of vaginal birth
Secondary outcomes:
- maternal adverse outcomes (PPH, blood transfusion, vaginal tears, hysterectomy, maternal death)
- fetal adverse outcomes (fetal death, NICU stay, APGAR score less than 7 at 5')
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2 | – | Procedure: Acceptance, rate of vaginal birth and safetyterm pregnant women with 2 previous CS from 01.01.2021 to 31.12.2025 |
| Group 1 | – | Procedure: Acceptance, rate of vaginal birth and safetyWomen with a history of two previous CS in period 01.01.2026 - 31-12.2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women attending birth in Santo Spirito Hospital Pescara (Italy) from 01-01-2016 to 31-12-2025
Key inclusion criteria (8 listed)
- pregnant women
- pregnancy above 34 weeks' gestation
- cephalic presentation of the fetus
- singleton and twins
- diamniotic twins
Key exclusion criteria (6 listed)
- pregnancy below 34 weeks' gestation
- breech baby
- triplets or high order multiple pregnancies
- more than 2 previous CS
- less than 18 months from last CS
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 |
|---|---|---|
| Acceptance, rate of vaginal birth and safetyIn 2021 started a new delivery protocol enhancing the opportunity of having a trial of labor in women with a history of two previous CS. Rate of acceptance, rate of successful vaginal birth, maternal and fetal outcomes were evaluated | Procedure or surgery | Group 1, Group 2 |
Primary outcome
vaginal birth after 2 cesarean
Time frame: 5 years
Incidence of patients having a vaginal birth after 2 CS
accepted indication to trial of labor
Time frame: 5 years
incidence of women accepting indication to trial of labor
3 secondary outcomes
emergency CS
Time frame: 5 years
maternal outcomes
Time frame: 5 years
Fetal and Neonatal adverse outcomes
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Results publication: PubMed 40771829Brandstetter M, Brandstetter A, Kainz-Schultes S, Jacobs VR, Fazelnia C, Fischer T, Bogner G. Successful Trial of Labor After Two Caesarean Sections (TOLA2C): Analysis of a Delivery Protocol with Feto-Maternal Outcome. Geburtshilfe Frauenheilkd. 2025 Feb 7;85(8):862-869. doi: 10.1055/a-2513-6562. eCollection 2025 Aug.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Delivery Affecting Fetus or Newborn and Labor (Obstetrics)--Complications, run by G. d'Annunzio University at 2 sites in Italy.
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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio Celentano, MD (+39 328 5577305, celentanoclaudio70@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vaginal birth after 2 cesarean (time frame: 5 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 NCT07258459, 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 2 Dec 2025.