UnknownNot Applicable

Treatment of Scars and Dysfunctions of the Pelvic Floor in Postpartum

Spain90 participantsStarted 2017-07-20

Plain-language summary

Recruitment of patients who have suffered third- and fourth-degree perineal tear during childbirth, and who have given birth at the Hospital Universitario Marqués de Valdecilla (Santander, Spain). They are distributed randomly in two groups an experimental group who apply techniques of physiotherapy and a control group, receiving medical treatment. At the same time is recruited the same number of patients who have not suffered tear and whose birth has been instrumental, dividing into two groups, control and experimental. And the same number of patients who have given birth but have not suffered tear or instrumental delivery, divided also into control group and experimental.

Who can participate

Age range

15 Years – 49 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: * Patients who have dysfunctions in the pelvic floor after childbirth * Patients who have given birth at the Hospital Universitario Marqués de Valdecilla * Patients who do not have any medical alteration that does not indicate the treatment Exclusion Criteria: * Patients who do not have pelvic floor dysfunctions after childbirth * Patients who have not given birth at the Hospital Universitario Marqués de Valdecilla * Patients who have any medical changes that counter the treatment

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

change in VAS from the start to the end

Timeframe: in the begining, at thirth month, at sixth month and at the finish (one year later)

Change in SF36 from de start to the end

Timeframe: in the begining, at thirth month, at sixth month and at the finish (one year later)

Change in EPIQ from de start to the end

Timeframe: in the begining, at thirth month, at sixth month and at the finish (one year later)

Change in OXFORD from the start to the end

Timeframe: in the begining, at thirth month, at sixth month and at the finish (one year later)

Trial details

NCT IDNCT04098965

SponsorUniversidad de León

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-20

Contact for this trial

M. Pilar Master

+34616965978 pilarvidacoli@hotmail.com

View on ClinicalTrials.gov More Pelvic Floor Disorders trials

Plain-language summary

Who can participate

Age range

15 Years – 49 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.

What they're measuring

change in VAS from the start to the end

Timeframe: in the begining, at thirth month, at sixth month and at the finish (one year later)

Change in SF36 from de start to the end

Timeframe: in the begining, at thirth month, at sixth month and at the finish (one year later)

Change in EPIQ from de start to the end

Timeframe: in the begining, at thirth month, at sixth month and at the finish (one year later)

Change in OXFORD from the start to the end

Timeframe: in the begining, at thirth month, at sixth month and at the finish (one year later)