NCT07037368

Brief 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). 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 17, 2025

Last Update Submit

June 17, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6 Months

Study Arms (1)

Impact of Delivery Mode

Behavioral: Impact of Delivery Mode

Interventions

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

Impact of Delivery Mode

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • Postpartum females aged 20-40 years
  • Females who delivered via vaginal delivery or cesarean section
  • weeks to 6 months postpartum period
  • Willingness to participate and provide informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Superior University CRC

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 25, 2025

Study Start

March 4, 2025

Primary Completion

June 1, 2025

Study Completion

September 30, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations