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

January 9, 2025 updated by: Claudio Celentano, G. d'Annunzio University

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vaginal birth
Time Frame: 4 years (Pescara)- 2.5 years (Florence)
Rate of vaginal birth
4 years (Pescara)- 2.5 years (Florence)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal outcomes
Time Frame: 4 years (Pescara)- 2.5 years (Florence)
Rate of PPH within cesarean section and vaginal deliveries
4 years (Pescara)- 2.5 years (Florence)
Fetal Neonatal outcomes
Time Frame: 4 years (Pescara)- 2.5 years (Florence)
Incidence of overall fetal neonatal outcomes (such as NICU stay, RDS, HPE, etc)
4 years (Pescara)- 2.5 years (Florence)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
G. d'Annunzio University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
San Giovanni di Dio Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Claudio Celentano, MD, University d'Annunzio Chieti Pescara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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