Perineal ultrasound
ProcedurePerineal ultrasound will be used after delivery to help detect anal sphincter ruptures.
NCT Number: NCT01905644
The main objective of this study is to compare post partum rates of anal sphincter rupture (that is to say the rate of sutures) diagnosed in women with ≥ 2nd degree vaginal tears between two groups: (1) women who are screened just after delivery by performing a perineal ultrasound versus a similar group of women who did not receive screening. This study was not designed to evaluate ultrasound as a diagnostic test but to compare the rate of perineal surgical procedures in each arm.
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Notify Me18 year and older
Female
Interventional
Not applicable
CHU de Montpellier - Hôpital Arnaud de Villeneuve, Montpellier, France
The secondary objectives of this study are:
A. Compare the anal incontinence score (measured by the Wexner score, qualitative and quantitative assessment) at 3 months between the two groups.
B. To assess the safety of perineal ultrasound in the group with "ultrasound" using a visual analog scale for discomfort
C. Assess the inter and intra operator consistency of perineal ultrasound snapshot readings
D. Evaluate and compare the rate of infectious complications of perineal sutures between the two groups at 3 months.
E. Evaluate and compare the quality of life (questionnaires PFIQ, PFDI, SF36, Euroqol) between the two groups at 3 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Perineal ultrasound will be used after delivery to help detect anal sphincter ruptures.
Time frame: Day 0
Time frame: Day 0
Time frame: 3 months
Time frame: Day 0
Visual analog scale (0 to 10) used to evaluate discomfort.
Time frame: Day 0
Time frame: Day 0
Time frame: 3 months
Time frame: Day 0
Time frame: 3 months
Time frame: Day 0
Time frame: 3 months
Time frame: Day 0
Time frame: 3 months
Time frame: Day 0
Time frame: 3 months
Centre Hospitalier Universitaire de Nīmes
Other
Verifying Anal Sphincter Integrity in the Delivery Room Using a Specific Perineal Ultrasound: Impact on Immediate Care and Postpartum Anal Incontinence Rates in Mothers Undergoing Vaginal Birth
Acronym: OASIS 2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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