CompletedNot Applicable

Verifying Post-delivery Anal Sphincter Integrity Using Perineal Ultrasound: Impact on Immediate Care

France276 participantsStarted 2014-03-07

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The patient must have given her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 3 months of follow-up * Paturient, vaginal births only * Presence of \>= stage 2 perineal lesion * Patient accepts a priori the performance of a perineal ultrasound Exclusion Criteria: * The patient is participating in another study (excepting BBBOX (2011-A00327-36), ElastoMAP (2013-A01148-37), ElastoDéclench, BAKRI, Papillo PMA, GrossPath, LXRs, DGPostPartum, "scalp lactates", and UpSideDown studies) * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * Delivery by C-section * Intact perineum after delivery (no indication for perineal surgery in light of absence of vaginal lesion) * Emergency situation preventing time for perineal ultrasound * History of anal incontinence before giving birth * Allergy to ultrasound gel

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Presence/absence of an anal sphincter rupture

Timeframe: Day 0

Trial details

NCT IDNCT01905644

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11-24

View on ClinicalTrials.gov More Delivery, Obstetric trials