Kegal Exercises With and Without Postural Correction on Postpartum Pelvic Organ Prolapse in Primiparous Women

NCT ID: NCT05851729

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-06-03

Brief Summary

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To study the effects of kegal exercises with and without postural correction on pelvic organ prolapse in primiparous women. Although pregnancy is a physiological process, it is associated with risk factors. These risk factors can put women at risk. One of the most common problems is pelvic floor muscle weakness, and this weakness of pelvic floor muscles causes many other problems, such as pelvic organ prolapse. Normal delivery (vaginal delivery) can cause laxity and weakness of ligaments such as the external urethral and pubourethral. Pelvic organs prolapse severely affects the quality of life of patients. Pelvic organ prolapse appears in women after vaginal delivery. Pelvic muscle training is a conservative treatment for many problems, including pelvic organ prolapse. However, the effects of pelvic floor muscle training for pelvic organ prolapse in primiparous women are controversial. This study is aimed at a systematic review of the effects of pelvic floor muscle training on pelvic organ prolapse in primiparous women.

Detailed Description

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The design of this study will randomize controlled trial. Data will collect from the Settings of Jinnah Hospital Lahore, THQ Hospital Depalpur, and Al-Shifa Hospital Depalpur. The sample size for this study is 30 primiparous women. Participants will be screened for eligibility. Women will be randomly assigned to the training group, which conducts 12 weekly individual sessions. Outcomes will be assessed after the last session. The control group will receive kegal exercise after the initial assessment. Main outcome measures for this study include the symptoms pelvic floor impact questionnaire, the pelvic floor distress inventory questionnaire, and the pelvic organ prolapse quantification examination. The pelvic floor impact questionnaire will assess the lifelong impact of pelvic floor disorders on women.

A pelvic floor distress inventory questionnaire will assess distress caused by PFD (pelvic floor dysfunction).

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Kegal exercises with postural correction

Group Type EXPERIMENTAL

Kegal exercises with postural correction

Intervention Type OTHER

Kegal exercises with postural correction

Kegal exercises without postural correction

Group Type EXPERIMENTAL

Kegal exercises without postural correction

Intervention Type OTHER

Kegal exercises without postural correction

Interventions

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Kegal exercises with postural correction

Kegal exercises with postural correction

Intervention Type OTHER

Kegal exercises without postural correction

Kegal exercises without postural correction

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Primiparous,Age: 20-40,
* 6th to 8th week after delivery,
* Singleton baby vaginally fully term,
* Non instrumented birth of child,
* Grade 1 prolapse (5)

Exclusion Criteria

* Women with Chronic Cough,
* Constipation,
* Previous Pelvic surgery,
* Pelvic malignancy,
* Genitourinary Infection
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hafiza Mehjabeen, MS(WHPT)

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Services Hospital

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Misbah Jaffar, MS(WHPT)

Role: CONTACT

03069680832

Facility Contacts

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Hafiza Mehjabeen, MSWHPT

Role: primary

03026577666

References

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Sigurdardottir T, Steingrimsdottir T, Geirsson RT, Halldorsson TI, Aspelund T, Bo K. Postpartum pelvic organ prolapse and pelvic floor muscle training: secondary analysis of a randomized controlled trial of primiparous women. Int Urogynecol J. 2023 Jun;34(6):1319-1326. doi: 10.1007/s00192-023-05502-8. Epub 2023 Mar 30.

Reference Type BACKGROUND
PMID: 36995416 (View on PubMed)

Artymuk NV, Khapacheva SY. Device-assisted pelvic floor muscle postpartum exercise programme for the management of pelvic floor dysfunction after delivery. J Matern Fetal Neonatal Med. 2022 Feb;35(3):481-485. doi: 10.1080/14767058.2020.1723541. Epub 2020 Feb 4.

Reference Type BACKGROUND
PMID: 32019378 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/23/0517

Identifier Type: -

Identifier Source: org_study_id

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