NCT05936866

Brief Summary

The study is aimed to determine the effects of pelvic floor stretching Vs strengthening on maternal birth outcomes and postpartum urogenital distress in primigravida.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

June 26, 2023

Last Update Submit

December 26, 2023

Conditions

Pregnancy Related

Keywords

Pregnancy RelatedPelvic Floor Muscle WeaknessDelivery Delayed

Outcome Measures

Primary Outcomes (3)

  • Mode of delivery

    Changes from the baseline outcome of Mode of Delivery will be taken from the delivery and labor records of the patients and also from the consultant Gynecologist.

    13th Week

  • Duration of labour

    Changes from the baseline outcome of Duration of labour will be taken from the delivery and labor records of the patients and also from the consultant Gynecologist. It will be measured in minutes/hours.

    13th Week

  • Number of vaginal inductions

    Changes from the baseline outcome of Number of vaginal inductions will be taken from the delivery and labor records of the patients and also from the consultant Gynecologist. It will be measured in minutes/hours.

    13th Week

Secondary Outcomes (1)

  • Urogenital Distress Inventory

    15th Week

Study Arms (2)

Pelvic floor stretching

EXPERIMENTAL

Pelvic floor stretching exercises

Other: Pelvic floor stretching

Pelvic floor strengthening

ACTIVE COMPARATOR

Pelvic floor strengthening Exercises

Other: Pelvic floor strengthening

Interventions

Pelvic floor stretchingOTHER

Week 1 to 4: Pelvic floor muscles awareness, Breathing exercises , seated pelvic tilts, cat stretches, seated hip openers (2 sets, 8 reps, sustained for 6 seconds) Week 5 to 8: Pelvic floor muscles awareness, Breathing exercises ,seated pelvic tilts, cat stretches, Seated hip openers, Relaxed Frog (2 sets, 8 reps, sustained for 6 seconds) Week 9 to 13: Pelvic floor muscles awareness, Breathing exercises, seated pelvic tilts, cat stretches, Seated hip openers, Relaxed Frog side lying clamshells, mini squats with support (2 sets, 9 reps, sustained for 7 seconds)

Pelvic floor stretching
Pelvic floor strengtheningOTHER

Week 1 to 4: Pelvic floor muscles awareness, Breathing exercises, 2 Sets of 10 Reps for pelvic floor squeeze and release Seated marching with elastic band with pelvic floor squeeze. Week 5 to 8: 2 sets x 9 Reps for Pelvic floor squeeze and release, Seated marching with elastic band with pelvic. 2 Sets x 8 Reps for bridging with pelvic floor squeeze, side lying hip circles Week 9 to 13: 2 sets 10 reps for Pelvic floor squeeze-and-release, Seated marching with elastic band with pelvic floor squeeze, pelvic bridging with pelvic floor squeeze, side lying hip circles with pelvic floor squeeze. 2 sets, 8 reps for . side lying Clamshells with resistance band and pelvic floor squeeze and plie squats with pelvic floor squeeze

Pelvic floor strengthening

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primigravida

You may not qualify if:

  • Any Contraindications to performing an exercise during pregnancy based on recommendations of the American College of Obstetricians and Gynecologists (ACOG)
  • females opting for Elective C section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doctors hospital

Abbottabad, KPK, 22020, Pakistan

Location

Study Officials

  • Sarah Ehsan, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 10, 2023

Study Start

June 13, 2023

Primary Completion

December 20, 2023

Study Completion

December 21, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)