Pregnancy RelatedNCT05936866
Effects of Antenatal Exercises on Maternal Birth Outcomes
A study testing Pelvic floor stretching and Pelvic floor strengthening in people with Pregnancy Related, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Pelvic floor stretching and Pelvic floor strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jun 2023to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primigravida
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- Pelvic floor stretching, Pelvic floor strengthening
- Keywords
- Pregnancy Related, Pelvic Floor Muscle Weakness, Delivery Delayed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor stretching | Experimental | Pelvic floor stretching exercises Receives: Other: Pelvic floor stretching |
| Pelvic floor strengthening | Active comparator | Pelvic floor strengthening Exercises Receives: Other: Pelvic floor strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 13th Week
Secondary outcomes (1)
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.
Measured: 15th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start13 Jun 2023
- Primary completion20 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Ehsan, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936866
- Sponsor's protocol ID
- REC/01537 Omama Sadaf
- Status last verified
- Dec 2023
- First submitted
- 26 Jun 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antenatal Pelvic Floor Stretching Vs Strengthening Exercises on Maternal Birth Outcomes in Primigravida
- ClinicalTrials.gov ID
- NCT05936866
- Acronym / sponsor ID
- REC/01537 Omama Sadaf
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy Related, Pelvic Floor Muscle Weakness, Delivery Delayed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is aimed to determine the effects of pelvic floor stretching Vs strengthening on maternal birth outcomes and postpartum urogenital distress in primigravida.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor stretching | Experimental | Other: Pelvic floor stretchingPelvic floor stretching exercises |
| Pelvic floor strengthening | Active comparator | Other: Pelvic floor strengtheningPelvic floor strengthening Exercises |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Primigravida
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor stretchingWeek 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) | Other | Pelvic floor stretching |
| Pelvic floor strengtheningWeek 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 | Other | Pelvic floor strengthening |
Primary outcome
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.
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.
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.
1 secondary outcome
Urogenital Distress Inventory
Time frame: 15th Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Ehsan, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor stretching and Pelvic floor strengthening in people with Pregnancy Related, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mode of delivery (time frame: 13th Week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.