Effects of Antenatal Exercises on Maternal Birth Outcomes
December 26, 2023 updated by: Riphah International University
Effect of Antenatal Pelvic Floor Stretching Vs Strengthening Exercises on Maternal Birth Outcomes in Primigravida
The study is aimed to determine the effects of pelvic floor stretching Vs strengthening on maternal birth outcomes and postpartum urogenital distress in primigravida.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
KPK
-
Abbottabad, KPK, Pakistan, 22020
- Doctors Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah Ehsan, PP-DPT, Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 13, 2023
Primary Completion (Actual)
December 20, 2023
Study Completion (Actual)
December 21, 2023
Study Registration Dates
First Submitted
June 26, 2023
First Submitted That Met QC Criteria
July 7, 2023
First Posted (Actual)
July 10, 2023
Study Record Updates
Last Update Posted (Estimated)
December 27, 2023
Last Update Submitted That Met QC Criteria
December 26, 2023
Last Verified
December 1, 2023
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)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.