CompletedNot Applicable

Perineal Physiotherapy in Postpartum

Spain240 participantsStarted 2016-10

Plain-language summary

Objective: To find out the effectiveness of pelvic-perineal physiotherapy in prevention and treatment of postpartum pelvic floor dysfunction caused by vaginal delivery.

Who can participate

Age range

18 Years – 45 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: * Postnatal women (6 and 8 weeks after vaginal delivery) * Primiparous * Whose vaginal delivery has occurred in the "Príncipe de Asturias" Hospital * Women have not been already treated for pelvic floor dysfunction * Women reading, understanding and freely signing an informed consent form Exclusion Criteria: * Postnatal women with medical diagnosis of pelvic floor dysfunction (PFD) prior to pregnancy and delivery * Women with a history of conservative treatment or PFD surgery * Women with concomitant or systemic disease that may affect the treatment (neurological, gynecological, urological or connective tissue), or with active or recurrent urinary infection without treatment at the time of the intervention proposed in this study, or hematuria * Postnatal women with cognitive limitations to understand information, respond to questionnaires, consent and / or participate in the study.

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 life impact of pelvic floor dysfunction

Timeframe: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.

Change in symptoms and quality of life

Timeframe: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.

Change in pelvic floor muscle strength

Timeframe: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.

Change in pelvic floor muscle characteristics

Timeframe: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.

Change in pelvic floor muscle strength

Timeframe: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.

Trial details

NCT IDNCT03247660

SponsorUniversity of Alcala

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12

View on ClinicalTrials.gov More Post Partum trials

Who can participate

Age range

18 Years – 45 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 life impact of pelvic floor dysfunction

Timeframe: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.

Change in symptoms and quality of life

Timeframe: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.

Change in pelvic floor muscle strength

Timeframe: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.

Change in pelvic floor muscle characteristics

Timeframe: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.

Change in pelvic floor muscle strength

Timeframe: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.