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Descriptive Evaluation of Expulsive Efforts During Pregnancy in Term Nulliparous Women by Measurement of Intra Bladder Pressure: Pilot Observational Study.

NCT04544488 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-01-11

No results posted yet for this study

Summary

Severe complications of childbirth are common. Many factors have been studied to assess their imputability in the occurrence of perineal tears. While women subjectively have different push profiles in terms of intensity, frequency and duration of each push effort, no study has evaluated this variability in a relevant, simple and reproducible way. Through this work, it is expected to establish a qualitative evaluation of the expulsive efforts during childbirth in term nulliparous women by measuring the intra bladder pressure which testifies of the pressure exerted on the perineal tissues due to maternal pushing efforts

Conditions

  • Perineal Tear

Interventions

PROCEDURE

Recording of expulsive efforts by connection of a pressure sensor to the women's bladder probe

Using a pressure probe connected to a Foley Catheter, intra bladder pressure wille be registered during the whole duration of expulsive phase. The device will be inserted into women's bladder using usual guidelines for insertion of Foley catheter

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-28
Primary Completion
2022-10-01
Completion
2022-10-01

Countries

  • France

Study Locations

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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 NCT04544488 on ClinicalTrials.gov