Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04544488
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2020-09-03
Brief Title:
Descriptive Evaluation of Expulsive Efforts During Pregnancy in Term Nulliparous Women by Measurement of Intra Bladder Pressure Pilot Observational Study
Sponsor:
Poitiers University Hospital
Organization:
Poitiers University Hospital
Study Overview
Official Title:
Descriptive Evaluation of Expulsive Efforts During Pregnancy in Term Nulliparous Women by Measurement of Intra Bladder Pressure Pilot Observational Study
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACCOUPIV
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 womans 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 womans 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
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 womans 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 womans 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None