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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cearean Section Rate; Maternal Adverse Outcomes; Neonatal Adverse Outcomes
• Intervention / Treatment: Other: cesarean section rate

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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Italy
  • FI
    • Florence, FI, Italy, 50143
      • San Giovanni di Dio Hospital
  • PE
    • Pescara, PE, Italy, 65121
      • Santo Spirito Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnancies after 34 weeks' gestation elegible for vaginal birth

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before; twin deliveries after 34 wks 2017 january-2020 December (Pescara), and 2020 January-2022 June (Florence)	Other: cesarean section rate; 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	Other: cesarean section rate; Incidence of cesarean sections in the two periods, Rate of adverse outcomes within vaginal and cesarean deliveries

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)	4 years (Pescara)- 2.5 years (Florence)

Collaborators and Investigators

• Sponsor: G. d'Annunzio University
• Collaborators: San Giovanni di Dio Hospital
• Investigators: Principal Investigator: Claudio Celentano, MD, University d'Annunzio Chieti Pescara

Publications and helpful links

Helpful Links

• University website

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: PPH; Twin vaginal birth; NICU stay
• Other Study ID Numbers: ObGynEASC007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No