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

NCT06628843 | Unknown DMC

• 1 other identifier: ObGynEASC007
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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

Conditions

Cearean Section Rate; Maternal Adverse Outcomes; Neonatal Adverse Outcomes

Keywords

Twin vaginal birth; PPH; NICU stay

Outcome Measures

Primary Outcomes (1)

• Vaginal birth

  Rate of vaginal birth

  4 years (Pescara)- 2.5 years (Florence)

Secondary Outcomes (2)

• Maternal outcomes

  4 years (Pescara)- 2.5 years (Florence)

• Fetal Neonatal outcomes

  4 years (Pescara)- 2.5 years (Florence)

Study Arms (2)

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

cesarean section rate OTHER

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

After; Before

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women with twin pregnancies after 34 weeks' gestation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnancies after 34 weeks' gestation elegible for vaginal birth

You may qualify if:

• twin pregnancies after 34 weeks

You may not qualify if:

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

Sponsors & Collaborators

• G. d'Annunzio University: lead
• San Giovanni di Dio Hospital: collaborator

Study Sites (2)

San Giovanni di Dio Hospital

Florence, FI, 50143, Italy

Location

Santo Spirito Hospital

Pescara, PE, 65121, Italy

Location

Related Links

• University website

Study Officials

• Claudio Celentano, MD

  University d'Annunzio Chieti Pescara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: January 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2024
• Last Updated: January 13, 2025

Record last verified: 2024-01

Locations

IT (2)