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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05936866
Other study ID # REC/01537 Omama Sadaf
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 13, 2023
Est. completion date December 21, 2023

Study information

Verified date December 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The effects of pelvic floor muscle exercises on the symptoms of postpartum urinary distress is not known, so there is a need to determine whether strengthening or stretching of pelvic floor muscles help in reducing the risk of developing urogenital distress in postpartum period of females. The positive effect of pelvic floor muscle training on duration of labor and maternal birth outcomes is understood. As stated in a systemic review of pelvic floor interventions during pregnancy. The researches done on effect of pelvic floor muscle exercises, included once a week supervised session of sustained pelvic floor muscle contractions with rest intervals and fast contractions with respective rest intervals along with daily home sessions of the same exercises.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date December 21, 2023
Est. primary completion date December 20, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Primigravida Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pelvic floor stretching
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 strengthening
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

Locations

Country Name City State
Pakistan Doctors hospital Abbottabad KPK

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Urogenital Distress Inventory UDI-6 is a widely used tool for the assessment of quality of life and symptoms of urinary incontinence in women. It is the short form which consists of 6 questions which are: frequent urination, leakage related to feeling of urgency, leakage related to activity, coughing or sneezing. Amount of drops of leakage, difficulty emptying the bladder and pain and discomfort in the lower abdominal or genital area. Scoring: Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. 15th Week
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