Pelvic Girdle PainNCT07037368
Impact of Delivery Mode on Coccydynia, Pelvic Girdle Pain and Rectus Diastasis in Postpartum Females
An observational study of Pelvic Girdle Pain and Rectus Diastasis, run by Superior University at 1 site in Pakistan.
Trial summary
This comparative observational study investigates the impact of delivery mode vaginal delivery versus cesarean section on the prevalence and severity of three postpartum musculoskeletal complications: coccydynia, pelvic girdle pain (PGP), and rectus diastasis (RD). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Girdle Pain, Rectus Diastasis
- What is being tested?
- Impact of Delivery Mode
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 73 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Mar 2025to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This comparative observational study investigates the impact of delivery mode vaginal delivery versus cesarean section on the prevalence and severity of three postpartum musculoskeletal complications: coccydynia, pelvic girdle pain (PGP), and rectus diastasis (RD).
Who may be able to join
- Postpartum females aged 20-40 years
- Females who delivered via vaginal delivery or cesarean section
- 6 weeks to 6 months postpartum period
- Willingness to participate and provide informed consent
Who cannot join
- Females with a history of pelvic or spinal surgery prior to pregnancy
- Known cases of pre-existing musculoskeletal disorders (e.g., scoliosis, chronic back pain)
- Multiple pregnancies (twins or more) in the current or previous delivery
- Postpartum complications unrelated to delivery mode (e.g., sepsis, trauma)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Delivery Mode on Coccydynia, Pelvic Girdle Pain and Rectus Diastasis in Postpartum Females: a Comparative Study
This comparative observational study investigates the impact of delivery mode vaginal delivery versus cesarean section on the prevalence and severity of three postpartum musculoskeletal complications: coccydynia, pelvic girdle pain (PGP), and rectus diastasis (RD). Conducted on postpartum females aged 20-40 years within 6 weeks to 6 months after childbirth, the study aims to highlight musculoskeletal outcomes often overlooked in standard postpartum care.
Read the detailed description
A total of 73 participants were selected through non-probability sampling from rehabilitation centers and home-based postpartum populations in Lahore. Pain intensity and musculoskeletal impairments were assessed using validated tools: the Visual Analog Scale (VAS) for coccydynia, Pelvic Girdle Questionnaire (PGQ) for PGP, and finger-width palpation technique for RD. The data collection involved both self-reported questionnaires and clinical assessments by trained professionals. The goal is to identify how delivery mode influences musculoskeletal health and to support the development of more tailored physiotherapy interventions and postpartum care strategies.
- Conditions
- Pelvic Girdle Pain, Rectus Diastasis
- Being tested
- Impact of Delivery Mode
- Medical subject headings
- Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of Delivery ModeBehavioural
investigates the impact of delivery mode vaginal delivery versus cesarean section on the prevalence and severity of three postpartum musculoskeletal complications: coccydynia, pelvic girdle pain (PGP), and rectus diastasis (RD). Conducted on postpartum females
| Study group | Role | What they receive |
|---|---|---|
| Impact of Delivery Mode | Not described Receives: Behavioral: Impact of Delivery Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
A 10 cm horizontal line marked from 0 (no pain) to 10 (worst imaginable pain). Scoring: The participant marks a point on the line that best represents their pain intensity. The score is measured in centimeters from the "no pain" end. Higher scores indicate more severe pain.
Measured: 6 Month
Pelvic Girdle Questionnaire (PGQ)
Contains 25 items divided into two domains: activity limitations (20 items) and symptoms (5 items).
Scoring: Each item is rated on a 4-point scale (0 = not at all, 1 = to a small extent, 2 = to some extent, 3 = to a great extent). Scores are summed, converted into a percentage of the maximum possible score. Higher percentages reflect greater pelvic girdle pain and disability.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start4 Mar 2025
- Primary completion1 Jun 2025
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- More trials run by Superior 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037368
- Sponsor's protocol ID
- DPT/Batch-Fall20/1015
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Delivery Mode on Coccydynia, Pelvic Girdle Pain and Rectus Diastasis in Postpartum Females: a Comparative Study
- ClinicalTrials.gov ID
- NCT07037368
- Acronym / sponsor ID
- DPT/Batch-Fall20/1015
- Conditions
- Pelvic Girdle Pain, Rectus Diastasis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Jun 2025 (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.
This comparative observational study investigates the impact of delivery mode vaginal delivery versus cesarean section on the prevalence and severity of three postpartum musculoskeletal complications: coccydynia, pelvic girdle pain (PGP), and rectus diastasis (RD). Conducted on postpartum females aged 20-40 years within 6 weeks to 6 months after childbirth, the study aims to highlight musculoskeletal outcomes often overlooked in standard postpartum care.
Detailed description
A total of 73 participants were selected through non-probability sampling from rehabilitation centers and home-based postpartum populations in Lahore. Pain intensity and musculoskeletal impairments were assessed using validated tools: the Visual Analog Scale (VAS) for coccydynia, Pelvic Girdle Questionnaire (PGQ) for PGP, and finger-width palpation technique for RD. The data collection involved both self-reported questionnaires and clinical assessments by trained professionals. The goal is to identify how delivery mode influences musculoskeletal health and to support the development of more tailored physiotherapy interventions and postpartum care strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impact of Delivery Mode | – | Behavioral: Impact of Delivery Mode |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This comparative observational study investigates the impact of delivery mode vaginal delivery versus cesarean section on the prevalence and severity of three postpartum musculoskeletal complications: coccydynia, pelvic girdle pain (PGP), and rectus diastasis (RD).
Key inclusion criteria (4 listed)
- Postpartum females aged 20-40 years
- Females who delivered via vaginal delivery or cesarean section
- 6 weeks to 6 months postpartum period
- Willingness to participate and provide informed consent
Key exclusion criteria (4 listed)
- Females with a history of pelvic or spinal surgery prior to pregnancy
- Known cases of pre-existing musculoskeletal disorders (e.g., scoliosis, chronic back pain)
- Multiple pregnancies (twins or more) in the current or previous delivery
- Postpartum complications unrelated to delivery mode (e.g., sepsis, trauma)
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 |
|---|---|---|
| Impact of Delivery Modeinvestigates the impact of delivery mode vaginal delivery versus cesarean section on the prevalence and severity of three postpartum musculoskeletal complications: coccydynia, pelvic girdle pain (PGP), and rectus diastasis (RD). Conducted on postpartum females | Behavioural | Impact of Delivery Mode |
Primary outcome
Visual Analog Scale
Time frame: 6 Month
A 10 cm horizontal line marked from 0 (no pain) to 10 (worst imaginable pain). Scoring: The participant marks a point on the line that best represents their pain intensity. The score is measured in centimeters from the "no pain" end. Higher scores indicate more severe pain.
Pelvic Girdle Questionnaire (PGQ)
Time frame: 6 Months
Contains 25 items divided into two domains: activity limitations (20 items) and symptoms (5 items). Scoring: Each item is rated on a 4-point scale (0 = not at all, 1 = to a small extent, 2 = to some extent, 3 = to a great extent). Scores are summed, converted into a percentage of the maximum possible score. Higher percentages reflect greater pelvic girdle pain and disability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Girdle Pain and Rectus Diastasis, run by Superior 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual Analog Scale (time frame: 6 Month). The study lists 2 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 25 Jun 2025.