Twin Vaginal Breech Deliveries Before and After Starting... | NCT06628843

Studies
Twin Vaginal Breech Deliveries Before and After Starting Training Skills and Clinical Approach in Labor Ward

NCT06628843

Sponsor

G. d'Annunzio University

Status

Unknown status

Last Update Posted

Jan 13, 2025Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Cearean Section Rate
Maternal Adverse Outcomes
Neonatal Adverse Outcomes

Interventions

cesarean section rate

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Oct 3, 2024

First Submission Date that Met QC Criteria

Oct 3, 2024

First Posted Date

Oct 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2025

Last Update Posted Date

Jan 13, 2025Actual

Name	Class
San Giovanni di Dio Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Before		twin deliveries after 34 wks 2017 january-2020 December (Pescara), and 2020 January-2022 June (Florence)	Other: cesarean section rate
After		twin deliveries after 34 wks January 2021-december 2024 (Pescara), and July 2022-December 2024	Other: cesarean section rate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cesarean section rate	Other	Incidence of cesarean sections in the two periods, Rate of adverse outcomes within vaginal and cesarean deliveries	After Before

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vaginal birth	Rate of vaginal birth	4 years (Pescara)- 2.5 years (Florence)

Secondary Outcomes

Measure	Description	Time Frame
Maternal outcomes	Rate of PPH within cesarean section and vaginal deliveries	4 years (Pescara)- 2.5 years (Florence)
Fetal Neonatal outcomes	Incidence of overall fetal neonatal outcomes (such as NICU stay, RDS, HPE, etc)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

twin pregnancies after 34 weeks

Exclusion Criteria:

multiple pregnancies monochorionic monoamniotic pregnancies gestational age before 34 weeks completed cesarean indication unrelated to pregnancy (placenta previa, maternal diseases, etc)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women with twin pregnancies after 34 weeks' gestation

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnancies after 34 weeks' gestation elegible for vaginal birth

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudio Celentano, MD	University d'Annunzio Chieti Pescara	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Giovanni di Dio Hospital		Florence	FI	50143	Italy
Santo Spirito Hospital

Label	URL
University website	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided