- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05936866
Effects of Antenatal Exercises on Maternal Birth Outcomes
Effect of Antenatal Pelvic Floor Stretching Vs Strengthening Exercises on Maternal Birth Outcomes in Primigravida
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
KPK
-
Abbottabad, KPK, Pakistan, 22020
- Doctors Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pelvic floor stretching
Pelvic floor stretching exercises
|
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)
|
|
Active Comparator: Pelvic floor strengthening
Pelvic floor strengthening Exercises
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mode of delivery
Time Frame: 13th Week
|
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
Time Frame: 13th Week
|
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
Time Frame: 13th Week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urogenital Distress Inventory
Time Frame: 15th Week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sarah Ehsan, PP-DPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REC/01537 Omama Sadaf
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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