Descriptive Evaluation of Expulsive Efforts During Pregnancy in Term Nulliparous Women by Measurement of Intra Bladder Pressure: Pilot Observational Study.
- Conditions
- Perineal Tear
- Registration Number
- NCT04544488
- Lead Sponsor
- Poitiers University Hospital
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method characteristics of the pushing efforts assessed by measuring intra bladder pressur Day of inclusion 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.
- Secondary Outcome Measures
Name Time Method Perineal tear Day of inclusion, immediately after delivery According the RCOG Classification
Clinical pelvic organ mobility 12 to 16 weeks after inclusion then 26 to 30 weeks after inclusion POP-Q clinical examination
Ultrasound pelvic organ mobility 12 to 16 weeks after inclusion then 26 to 30 weeks after inclusion Transperineal pelvic floor ultrasound
Trial Locations
- Locations (1)
CHU Poitiers
🇫🇷Poitiers, France