Clinical trial NCT04544488: Descriptive Evaluation of Expulsive Efforts During Pregnancy in Term Nulliparous Women by Measurement of Intra Bladder Pressure: Pilot Observational Study.
Official title: Descriptive Evaluation of Expulsive Efforts During Pregnancy in Term Nulliparous Women by Measurement of Intra Bladder Pressure: Pilot Observational Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perineal Tear
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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

Eligibility criteria: * 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

Primary outcomes:
measure: characteristics of the pushing efforts assessed by measuring intra bladder pressur
timeFrame: Day of inclusion
Secondary outcomes:
measure: Perineal tear
timeFrame: Day of inclusion, immediately after delivery
measure: Clinical pelvic organ mobility
timeFrame: 12 to 16 weeks after inclusion then 26 to 30 weeks after inclusion
measure: Ultrasound pelvic organ mobility
timeFrame: 12 to 16 weeks after inclusion then 26 to 30 weeks after inclusion
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References: