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

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

Study Overview

• Status: Recruiting
• Conditions: Perineal Tear
• Intervention / Treatment: Procedure: Recording of expulsive efforts by connection of a pressure sensor to the women's bladder probe

Detailed Description

Scientific context:

It is clearly observed in clinical practice that there seems to be significant variability in the characteristics of the expulsive phase from one woman to another without this being clearly described to date. During the same expulsive phase, the number, intensity and duration of each push can be very different from one woman to another.

Considering that during expulsive efforts, the fetal head exerts pressure on the perineal tissues , the repetition of these compressions, moreover if they are prolonged or brought closer together could generate muscular lesions by hyper extension of the fibers, by microtrauma or by tissue hypoxia. These variations in the characteristics of expulsive efforts could thus modify the perineal risk for women.

More than the expulsive efforts evaluated by the recording of intra uterine pressures which has already been described, it is the evaluation of the mechanical stresses transmitted to the perineum secondary to the pushing efforts that we would like to record by the installation of a sensor pressure connected to the woman's bladder catheter.

Investigations During the second phase of labor, at 8 cm dilation, after information and obtaining free and informed consent, women will be included by one of the MD investigators.

3 visits are planned in the protocol: The first visit will be at childbirth Evaluation of the mechanical stresses transmitted to the perineum secondary to the pushing efforts by the installation of a sensor pressure connected to the woman's bladder catheter

Follow up A prospective study including nulliparous term pregnant women with 2 other visits planned at 3 months (12 to 16 weeks) and 6 months (26 to 30 weeks) after delivery, to assess secondary perineal complications

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bertrand GACHON, MD; PhD Student; Phone Number: + 33 5 49 44 39 45; Email: bertrand.gachon@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France
    • Recruiting
    • CHU Poitiers
    • Contact: Bertrand GACHON, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

• Inclusion criteria :

  • Pregnant women aged of 18 years or more
  • 37 weeks or more of pregnancy
  • Without any previous delivery (vaginal or cesarean delivery)
  • With a cephalic presentation fetus
  • With epidural analgesia at 8 cm cervical dilatation (inclusion)

• - Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perineal tear	According the RCOG Classification	Day of inclusion, immediately after delivery
Clinical pelvic organ mobility	POP-Q clinical examination	12 to 16 weeks after inclusion then 26 to 30 weeks after inclusion
Ultrasound pelvic organ mobility	Transperineal pelvic floor ultrasound	12 to 16 weeks after inclusion then 26 to 30 weeks after inclusion

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 28, 2021
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (ACTUAL): September 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ACCOUPIV

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