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Vacuum Delivery in All-fours Position vs Traditional Position

NCT05612321 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2022-11-10

No results posted yet for this study

Summary

The aim of the study is to investigate the safety, clinical efficacy and the maternal/neonatal outcomes of vacuum application in all-fours position compared with supine traditional position, in women undergoing vacuum-assisted delivery during the second stage of labor.

The main question it aims to answer are:

* Does the rate of failure of vacuum delivery, measured as number of cup detachments and the need of emergency caesarean section is lower if vacuum delivery is performed on a woman in all-fours position?
* Do maternal and fetal outcomes are better in case vacuum delivery in all-fours position?

Participants will be randomly enrolled at the admission in two different groups, Control and Experimental Group, and in case of need for vacuum-assisted vaginal delivery; women belonging to Control Group will undergo vacuum-assisted delivery in traditional supine position, while women in Experimental Group will experience vacuum application in all-fours position.

Researchers will compare the Group A, composed by women who undergo vacuum-delivery in traditional supine position, with Group B, in which women are in "all-fours" position, to see if hands-and-knees position provides better outcomes.

Conditions

  • Prolonged Second Stage of Labor
  • Prolonged Second Stage of Labor Due to Poor Maternal Effort

Interventions

DEVICE

Vacuum application

vacuum-assisted delivery

Sponsors & Collaborators

  • Ospedale degli Infermi di Biella

    lead OTHER

Principal Investigators

  • Bianca Masturzo, Md, PhD · Ospedale degli Infermi di Biella

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-05-01
Completion
2023-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05612321 on ClinicalTrials.gov