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

NCT ID: NCT06628843

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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

Conditions

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Cearean Section Rate Maternal Adverse Outcomes Neonatal Adverse Outcomes

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Before

twin deliveries after 34 wks 2017 january-2020 December (Pescara), and 2020 January-2022 June (Florence)

cesarean section rate

Intervention Type OTHER

Incidence of cesarean sections in the two periods, Rate of adverse outcomes within vaginal and cesarean deliveries

After

twin deliveries after 34 wks January 2021-december 2024 (Pescara), and July 2022-December 2024

cesarean section rate

Intervention Type OTHER

Incidence of cesarean sections in the two periods, Rate of adverse outcomes within vaginal and cesarean deliveries

Interventions

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cesarean section rate

Incidence of cesarean sections in the two periods, Rate of adverse outcomes within vaginal and cesarean deliveries

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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San Giovanni di Dio Hospital

OTHER

Sponsor Role collaborator

G. d'Annunzio University

OTHER

Sponsor Role lead

Responsible Party

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Claudio Celentano

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudio Celentano, MD

Role: PRINCIPAL_INVESTIGATOR

University d'Annunzio Chieti Pescara

Locations

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San Giovanni di Dio Hospital

Florence, FI, Italy

Site Status

Santo Spirito Hospital

Pescara, PE, Italy

Site Status

Countries

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Italy

Related Links

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http://www.unich.it

University website

Other Identifiers

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ObGynEASC007

Identifier Type: -

Identifier Source: org_study_id

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