Cearean Section RateTVBDNCT06628843
Twin Vaginal Breech Deliveries Before and After Starting Training Skills and Clinical Approach in Labor Ward
An observational study of Cearean Section Rate and Maternal Adverse Outcomes, run by G. d'Annunzio University at 2 sites in Italy.
Trial summary
In January 2021 Dept of ObGyn of Santo Spirito Hospital Pescara Italy, and in July 2022 Dept of ObGyn of San Giovanni di Dio Hospital Florence Italy, started regular training in management of obstetric emergencies. Twin vaginal deliveries were considered when first fetus is vertex presenting. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cearean Section Rate, Maternal Adverse Outcomes, Neonatal Adverse Outcomes
- What is being tested?
- cesarean section rate
- How many people
- 500 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2017to 31 Dec 2024
- How long will I take part?
- 4 Years
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnancies after 34 weeks' gestation elegible for vaginal birth
Who may be able to join
- twin pregnancies after 34 weeks
Who cannot join
- multiple pregnancies monochorionic monoamniotic pregnancies gestational age before 34 weeks completed cesarean indication unrelated to pregnancy (placenta previa, maternal diseases, etc)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
San Giovanni di Dio Hospital
Florence, FI, 50143
Santo Spirito Hospital
Pescara, PE, 65121
About this study
Official title: Twin Vaginal Deliveries and Maternal-fetal Outcomes Before and After Starting Training of Teamworks
In January 2021 Dept of ObGyn of Santo Spirito Hospital Pescara Italy, and in July 2022 Dept of ObGyn of San Giovanni di Dio Hospital Florence Italy, started regular training in management of obstetric emergencies. Twin vaginal deliveries were considered when first fetus is vertex presenting. The present study is evaluating retrospectively the rate of vaginal birth in twins after 34 weeks' gestation in the period 2017-2020, and 2021-2024 for Santo Spirito Hospital Pescara, and 2020-2022 June, and July 2022-2024 for San Giovanni di Dio Hospital Pescara. Incidence of maternal and fetal/neonatal outcomes were considered. Policy in Pescara hospital is based on cultural support of teamworks working in labor ward. Florence policy is based on availability of two teamworks previously skilled for twin vaginal delivery
Read the detailed description
In the period 2017-2020 before starting of simulator training for obstetrics emergencies, twin birth were collected. Incidence of vaginal birth and incidence of maternal adverse outcome (such as PPH) and fetal/neonatal adverse outcome (such as NICU stay) were recorded. The same outcomes were collected in twin deliveries after 34 wks in the period 2021-2024. Similarly in San Giovanni di Dio Hospital Florence they started this protocol in July 2022. The retrospective data enrollement identified the period January 2020-June 2022 and July 2022-December 2024. Teamworks in Pescara Hospital were supported by continous formation for retaining skills on vaginal birth particularly twin vaginal deliveries. In Florence Hospital two teamworks were supporting patients wondering for a vaginal birth and in the meantime positive results were collected in labor ward
- Being tested
- cesarean section rate
- Keywords
- Twin vaginal birth, PPH, NICU stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cesarean section rateOther
Incidence of cesarean sections in the two periods, Rate of adverse outcomes within vaginal and cesarean deliveries
| Study group | Role | What they receive |
|---|---|---|
| Before | twin deliveries after 34 wks 2017 january-2020 December (Pescara), and 2020 January-2022 June (Florence) Receives: Other: cesarean section rate | |
| After | twin deliveries after 34 wks January 2021-december 2024 (Pescara), and July 2022-December 2024 Receives: Other: cesarean section rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal birth
Rate of vaginal birth
Measured: 4 years (Pescara)- 2.5 years (Florence)
Secondary outcomes (2)
Maternal outcomes
Rate of PPH within cesarean section and vaginal deliveries
Measured: 4 years (Pescara)- 2.5 years (Florence)
Fetal Neonatal outcomes
Incidence of overall fetal neonatal outcomes (such as NICU stay, RDS, HPE, etc)
Measured: 4 years (Pescara)- 2.5 years (Florence)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Jan 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cearean Section RateStudies 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Collaborators
- San Giovanni di Dio Hospital
- Responsible party
- Principal investigator, Claudio Celentano, G. d'Annunzio University
- Investigators
- Claudio Celentano, MD, Principal investigator, University d'Annunzio Chieti Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628843
- Sponsor's protocol ID
- ObGynEASC007
- Acronym
- TVBD
- Status last verified
- Jan 2024
- First submitted
- 3 Oct 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twin Vaginal Deliveries and Maternal-fetal Outcomes Before and After Starting Training of Teamworks
- ClinicalTrials.gov ID
- NCT06628843
- Acronym / sponsor ID
- TVBD / ObGynEASC007
- Keywords
- Twin vaginal birth, PPH, NICU stay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Collaborators
- San Giovanni di Dio Hospital
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Oct 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.
In January 2021 Dept of ObGyn of Santo Spirito Hospital Pescara Italy, and in July 2022 Dept of ObGyn of San Giovanni di Dio Hospital Florence Italy, started regular training in management of obstetric emergencies. Twin vaginal deliveries were considered when first fetus is vertex presenting. The present study is evaluating retrospectively the rate of vaginal birth in twins after 34 weeks' gestation in the period 2017-2020, and 2021-2024 for Santo Spirito Hospital Pescara, and 2020-2022 June, and July 2022-2024 for San Giovanni di Dio Hospital Pescara. Incidence of maternal and fetal/neonatal outcomes were considered. Policy in Pescara hospital is based on cultural support of teamworks working in labor ward. Florence policy is based on availability of two teamworks previously skilled for twin vaginal delivery
Detailed description
In the period 2017-2020 before starting of simulator training for obstetrics emergencies, twin birth were collected. Incidence of vaginal birth and incidence of maternal adverse outcome (such as PPH) and fetal/neonatal adverse outcome (such as NICU stay) were recorded. The same outcomes were collected in twin deliveries after 34 wks in the period 2021-2024. Similarly in San Giovanni di Dio Hospital Florence they started this protocol in July 2022. The retrospective data enrollement identified the period January 2020-June 2022 and July 2022-December 2024. Teamworks in Pescara Hospital were supported by continous formation for retaining skills on vaginal birth particularly twin vaginal deliveries. In Florence Hospital two teamworks were supporting patients wondering for a vaginal birth and in the meantime positive results were collected in labor ward
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before | – | Other: cesarean section ratetwin deliveries after 34 wks 2017 january-2020 December (Pescara), and 2020 January-2022 June (Florence) |
| After | – | Other: cesarean section ratetwin deliveries after 34 wks January 2021-december 2024 (Pescara), and July 2022-December 2024 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnancies after 34 weeks' gestation elegible for vaginal birth
Key inclusion criteria (1 listed)
- twin pregnancies after 34 weeks
Key exclusion criteria (1 listed)
- multiple pregnancies monochorionic monoamniotic pregnancies gestational age before 34 weeks completed cesarean indication unrelated to pregnancy (placenta previa, maternal diseases, etc)
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 |
|---|---|---|
| cesarean section rateIncidence of cesarean sections in the two periods, Rate of adverse outcomes within vaginal and cesarean deliveries | Other | After, Before |
Primary outcome
Vaginal birth
Time frame: 4 years (Pescara)- 2.5 years (Florence)
Rate of vaginal birth
2 secondary outcomes
Maternal outcomes
Time frame: 4 years (Pescara)- 2.5 years (Florence)
Fetal Neonatal outcomes
Time frame: 4 years (Pescara)- 2.5 years (Florence)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- University websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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 d'Annunzio Chieti Pescara
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 Cearean Section Rate and Maternal Adverse Outcomes, 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 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: status not confirmed, as of the sponsor's last update on 13 Jan 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?
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?
Vaginal birth (time frame: 4 years (Pescara)- 2.5 years (Florence)). 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 13 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.