Clinical trial NCT06628843: Twin Vaginal Breech Deliveries Before and After Starting Training Skills and Clinical Approach in Labor Ward
Official title: Twin Vaginal Deliveries and Maternal-fetal Outcomes Before and After Starting Training of Teamworks
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cearean Section Rate
Maternal Adverse Outcomes
Neonatal Adverse Outcomes
Keywords: Twin vaginal birth
PPH
NICU stay
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
Collaborators: name: San Giovanni di Dio Hospital
First posted: 2024-10-08
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnancies after 34 weeks' gestation elegible for vaginal birth

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

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)

Primary outcomes:
measure: Vaginal birth
timeFrame: 4 years (Pescara)- 2.5 years (Florence)
Secondary outcomes:
measure: Maternal outcomes
timeFrame: 4 years (Pescara)- 2.5 years (Florence)
measure: Fetal Neonatal outcomes
timeFrame: 4 years (Pescara)- 2.5 years (Florence)
Other outcomes:
Locations:
city: Florence
country: Italy
facility: San Giovanni di Dio Hospital
state: FI
city: Pescara
country: Italy
facility: Santo Spirito Hospital
state: PE
Study officials:
affiliation: University d'Annunzio Chieti Pescara
name: Claudio Celentano, MD
role: PRINCIPAL_INVESTIGATOR
References: