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

NCT04544488 | Unknown

• 1 other identifier: ACCOUPIV
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• characteristics of the pushing efforts assessed by measuring intra bladder pressur

  At inclusion it will be collect the characteristics of the pushing efforts: the intensity, the duration (total and of each effort) and the frequency of the expulsive efforts, which will be described in terms of mean and standard deviation.

  Day of inclusion

Secondary Outcomes (3)

• Perineal tear

  Day of inclusion, immediately after delivery

• Clinical pelvic organ mobility

  12 to 16 weeks after inclusion then 26 to 30 weeks after inclusion

• Ultrasound pelvic organ mobility

  12 to 16 weeks after inclusion then 26 to 30 weeks after inclusion

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged of 18 years or more
• weeks or more of pregnancy
• Without any previous delivery (vaginal or cesarean delivery)
• With a cephalic presentation fetus

You may not qualify if:

• Pathological pregnancy (intrauterine growth restriction, pre-eclampsia etc.)
• Untreated psychiatric disorders
• Women under judicial protection
• Women without health insurance

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU Poitiers

Poitiers, France

RECRUITING

Central Study Contacts

Bertrand GACHON, MD; PhD Student

CONTACT

+ 33 5 49 44 39 45; bertrand.gachon@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 10, 2020
• Study Start: December 28, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

FR (1)