Trials Sponsors Conditions Drugs Pricing

Conditions

Pelvic Floor Disorders Pelvic Floor; Perineal Rupture, Obstetric Physiotherapy

Outcome Measures

Primary Outcomes (24)

Feasibility of the trial.
The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.
4 months after delivery
Feasibility of the trial.
The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.
6 months after delivery
Feasibility of the trial.
The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.

Secondary Outcomes (13)

Pelvic Organ Prolapse Quantification Examination (POP-Q)
10-12 weeks after delivery
Pelvic Organ Prolapse Quantification Examination (POP-Q)
12 months after delivery
Age
10-12 weeks after delivery
Body mass index (BMI)
10-12 weeks after delivery
Body mass index (BMI)
12 months after delivery
+8 more secondary outcomes

Study Arms (3)

Intervention group

EXPERIMENTAL

intervention group will receive a physiotherapy individualized treatment

Other: Physiotherapy treatment

Control Group

NO INTERVENTION

No intervention in women with injury in the levator ani

Healthy controls

NO INTERVENTION

A group of women without injury that will be invited to filling in the questionnaires that will be carried out in the study three, six months and one year postpartum.

Interventions

Physiotherapy treatmentOther

physiotherapy individualized treatment according to the needs of the patient and clinical findings and symptoms

Intervention group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

simplex vaginal first delivery with a elevator ani injury
aged ≥18 years

Sponsors & Collaborators

Vastra Gotaland Region
Governmentlead

Study Sites (1)

Nu sjukvård

Trollhättan, Sweden

RECRUITING

Rocio MontejoCONTACT

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Study Officials

Rocio Montejo, PhD
Vastra Gotaland Region
PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocio Montejo, PhD

CONTACT

+46104352244 rocio.montejo.rodriguez@vgregion.se

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: HEALTH SERVICES RESEARCH
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: PhD

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 15, 2022

Study Start

April 1, 2023

Actual (reported)

Primary Completion

June 30, 2024

Estimated (date passed)

The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (24)

Secondary Outcomes (13)

Study Arms (3)

Intervention group

Control Group

Healthy controls

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (24)

Secondary Outcomes (13)

Study Arms (3)

Intervention group

Control Group

Healthy controls

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations