Cesarean and Vaginal Birth ComplicationsNCT05538325
Assessment of Lumbar Spine Active Range of Motion in Women Who Were Experienced Cesarean or Vaginal Birth
An observational study of Cesarean and Vaginal Birth Complications, run by South Valley University at 1 site in Egypt.
Trial summary
Pregnancy may impact the musculoskeletal apparatus of females through pregnancy-associated biomechanical, vascular, and hormonal changes. Pregnant females may complain of lumbopelvic pain, especially during their last trimester. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean and Vaginal Birth Complications
- What is being tested?
- Bubble Inclinometer and Digital Pelvic Inclinometer
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jun 2021to 5 Aug 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: 66 women participated in this study. They were recruited from the Woman and Child Hospital of South Valley University, located in Qena governorate, Egypt.
Who may be able to join
- All women either primiparous or multiparous have not had anaesthesia (epidural, spinal, or general) for at least one year prior to the last obstetric anaesthesia.
- Their ages ranged from 18 to 35 years.
- Participants were assessed between the 6th week to the 12th week postnatal.
- All participants were able to continue all assessment procedures.
- They might have a mild or moderate myofascial LBP
Who cannot join
- Women who were below 18 years old or above 35 years.
- Women who did not continue all assessment procedures.
- Women who had a severe myofascial LBP or any specific low back conditions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of physical therapy, South Valley University
Qina, Qena Governorate, 83523
About this study
Official title: After the End of the Puerperium: Kinematic Assessment of Lumbar Spine Active Range of Motion in Women Who Experienced Cesarean or Vaginal Birth
Pregnancy may impact the musculoskeletal apparatus of females through pregnancy-associated biomechanical, vascular, and hormonal changes. Pregnant females may complain of lumbopelvic pain, especially during their last trimester. This lumbopelvic pain can be the result of an enlarged uterus and unstable lumbopelvic joints.
Read the detailed description
Cesarean birth can affect the lumbopelvic biomechanics through its impact on the sacroiliac joints and the abdominal muscles. while vaginal birth can trigger lumbopelvic pain through its impact on the pelvic joints like the symphysis pubis and sacroiliacs.
When puerperium is finished, most of these pregnancy-related changes assume its prepregnant conditions.
Physiotherapists are responsible for providing PT care for women to improve their quality of life during the puerperium and even during the delayed postpartum interval.
- Conditions
- Cesarean and Vaginal Birth Complications
- Being tested
- Bubble Inclinometer and Digital Pelvic Inclinometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble Inclinometer and Digital Pelvic InclinometerDevice
They are valid and reliable devices to measure the range of motion of the lumbar spine
| Study group | Role | What they receive |
|---|---|---|
| Group A | 25 females who experienced cesarean birth Receives: Device: Bubble Inclinometer and Digital Pelvic Inclinometer | |
| Group B | 16 females who experienced vaginal birth Receives: Device: Bubble Inclinometer and Digital Pelvic Inclinometer | |
| Group C | 25 females who were the controls, did not experience any pregnancy Receives: Device: Bubble Inclinometer and Digital Pelvic Inclinometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Spine Extension Active Range of Motion
It represent the non-painful full range of motion from standing upright to leaning backward in the sagittal plane
Measured: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
Lumbar Spine Flexion Active Range of Motion
It represent the non-painful full range of motion from standing upright to leaning forward in the sagittal plane
Measured: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
Lumbar Spine Right Side Bending Active Range of Motion
It represent the non-painful full range of motion from standing upright to leaning sideway to the right in the frontal plane
Measured: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
Lumbar Spine Left Side Bending Active Range of Motion
It represent the non-painful full range of motion from standing upright to leaning sideway to the left in the frontal plane
Measured: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
Lumbar Spine Right Axial Rotation Active Range of Motion
It represents the non-painful full range of motion from standing with trunk forward bended 90 degree then head, neck, shoulders, and trunk rotation to the right side
Measured: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
Lumbar Spine Left Axial Rotation Active Range of Motion
It represents the non-painful full range of motion from standing with trunk forward bended 90 degree then head, neck, shoulders, and trunk rotation to the left side
Measured: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start28 Jun 2021
- Primary completion29 Jan 2022
- Study completion5 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cesarean and Vaginal Birth ComplicationsStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal Abouelyazeed Ali, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538325
- Sponsor's protocol ID
- Lumbar Spine ROM
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thabah M, Ravindran V. Musculoskeletal problems in pregnancy. Rheumatol Int. 2015 Apr;35(4):581-7. doi: 10.1007/s00296-014-3135-7. Epub 2014 Sep 25.
PubMed 25253297Kesikburun S, Guzelkucuk U, Fidan U, Demir Y, Ergun A, Tan AK. Musculoskeletal pain and symptoms in pregnancy: a descriptive study. Ther Adv Musculoskelet Dis. 2018 Nov 19;10(12):229-234. doi: 10.1177/1759720X18812449. eCollection 2018 Dec.
PubMed 30515249Ritchie JR. Orthopedic considerations during pregnancy. Clin Obstet Gynecol. 2003 Jun;46(2):456-66. doi: 10.1097/00003081-200306000-00024. No abstract available.
PubMed 12808395Franklin ME, Conner-Kerr T. An analysis of posture and back pain in the first and third trimesters of pregnancy. J Orthop Sports Phys Ther. 1998 Sep;28(3):133-8. doi: 10.2519/jospt.1998.28.3.133.
PubMed 9742469Sung S, Mahdy H. Cesarean section. InStatPearls [Internet] 2021 Apr 25. StatPearls Publishing.
Sanya AO, Olajitan A. Comparison of abdominal muscle strength in post-parous and nil parous subjects. Afr J Med Med Sci. 1999 Mar-Jun;28(1-2):49-53.
PubMed 12953987Fan C, Guidolin D, Ragazzo S, Fede C, Pirri C, Gaudreault N, Porzionato A, Macchi V, De Caro R, Stecco C. Effects of Cesarean Section and Vaginal Delivery on Abdominal Muscles and Fasciae. Medicina (Kaunas). 2020 May 27;56(6):260. doi: 10.3390/medicina56060260.
PubMed 32471194Ghodke PS, Shete D, Anap D. Prevalence of sacroiliac joint dysfunction in postpartum women-a cross sectional study. Physiother Rehabil. 2017;2(3):149.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- After the End of the Puerperium: Kinematic Assessment of Lumbar Spine Active Range of Motion in Women Who Experienced Cesarean or Vaginal Birth
- ClinicalTrials.gov ID
- NCT05538325
- Acronym / sponsor ID
- Lumbar Spine ROM
- Conditions
- Cesarean and Vaginal Birth Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 29 Jan 2022 (actual)
- Study completion
- 5 Aug 2023 (actual)
- First posted
- 13 Sep 2022 (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.
Pregnancy may impact the musculoskeletal apparatus of females through pregnancy-associated biomechanical, vascular, and hormonal changes. Pregnant females may complain of lumbopelvic pain, especially during their last trimester. This lumbopelvic pain can be the result of an enlarged uterus and unstable lumbopelvic joints.
Detailed description
Cesarean birth can affect the lumbopelvic biomechanics through its impact on the sacroiliac joints and the abdominal muscles. while vaginal birth can trigger lumbopelvic pain through its impact on the pelvic joints like the symphysis pubis and sacroiliacs.
When puerperium is finished, most of these pregnancy-related changes assume its prepregnant conditions.
Physiotherapists are responsible for providing PT care for women to improve their quality of life during the puerperium and even during the delayed postpartum interval.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: Bubble Inclinometer and Digital Pelvic Inclinometer25 females who experienced cesarean birth |
| Group B | – | Device: Bubble Inclinometer and Digital Pelvic Inclinometer16 females who experienced vaginal birth |
| Group C | – | Device: Bubble Inclinometer and Digital Pelvic Inclinometer25 females who were the controls, did not experience any pregnancy |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 66 women participated in this study. They were recruited from the Woman and Child Hospital of South Valley University, located in Qena governorate, Egypt.
Key inclusion criteria (5 listed)
- All women either primiparous or multiparous have not had anaesthesia (epidural, spinal, or general) for at least one year prior to the last obstetric anaesthesia.
- Their ages ranged from 18 to 35 years.
- Participants were assessed between the 6th week to the 12th week postnatal.
- All participants were able to continue all assessment procedures.
- They might have a mild or moderate myofascial LBP
Key exclusion criteria (3 listed)
- Women who were below 18 years old or above 35 years.
- Women who did not continue all assessment procedures.
- Women who had a severe myofascial LBP or any specific low back conditions.
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 |
|---|---|---|
| Bubble Inclinometer and Digital Pelvic InclinometerThey are valid and reliable devices to measure the range of motion of the lumbar spine | Device | Group A, Group B, Group C |
Primary outcome
Lumbar Spine Extension Active Range of Motion
Time frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
It represent the non-painful full range of motion from standing upright to leaning backward in the sagittal plane
Lumbar Spine Flexion Active Range of Motion
Time frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
It represent the non-painful full range of motion from standing upright to leaning forward in the sagittal plane
Lumbar Spine Right Side Bending Active Range of Motion
Time frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
It represent the non-painful full range of motion from standing upright to leaning sideway to the right in the frontal plane
Lumbar Spine Left Side Bending Active Range of Motion
Time frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
It represent the non-painful full range of motion from standing upright to leaning sideway to the left in the frontal plane
Lumbar Spine Right Axial Rotation Active Range of Motion
Time frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
It represents the non-painful full range of motion from standing with trunk forward bended 90 degree then head, neck, shoulders, and trunk rotation to the right side
Lumbar Spine Left Axial Rotation Active Range of Motion
Time frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
It represents the non-painful full range of motion from standing with trunk forward bended 90 degree then head, neck, shoulders, and trunk rotation to the left side
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 2 Oct 2025.
- Background: PubMed 25253297Thabah M, Ravindran V. Musculoskeletal problems in pregnancy. Rheumatol Int. 2015 Apr;35(4):581-7. doi: 10.1007/s00296-014-3135-7. Epub 2014 Sep 25.
- Background: PubMed 30515249Kesikburun S, Guzelkucuk U, Fidan U, Demir Y, Ergun A, Tan AK. Musculoskeletal pain and symptoms in pregnancy: a descriptive study. Ther Adv Musculoskelet Dis. 2018 Nov 19;10(12):229-234. doi: 10.1177/1759720X18812449. eCollection 2018 Dec.
- Background: PubMed 12808395Ritchie JR. Orthopedic considerations during pregnancy. Clin Obstet Gynecol. 2003 Jun;46(2):456-66. doi: 10.1097/00003081-200306000-00024. No abstract available.
- Background: PubMed 9742469Franklin ME, Conner-Kerr T. An analysis of posture and back pain in the first and third trimesters of pregnancy. J Orthop Sports Phys Ther. 1998 Sep;28(3):133-8. doi: 10.2519/jospt.1998.28.3.133.
- BackgroundSung S, Mahdy H. Cesarean section. InStatPearls [Internet] 2021 Apr 25. StatPearls Publishing.
- Background: PubMed 12953987Sanya AO, Olajitan A. Comparison of abdominal muscle strength in post-parous and nil parous subjects. Afr J Med Med Sci. 1999 Mar-Jun;28(1-2):49-53.
- Background: PubMed 32471194Fan C, Guidolin D, Ragazzo S, Fede C, Pirri C, Gaudreault N, Porzionato A, Macchi V, De Caro R, Stecco C. Effects of Cesarean Section and Vaginal Delivery on Abdominal Muscles and Fasciae. Medicina (Kaunas). 2020 May 27;56(6):260. doi: 10.3390/medicina56060260.
- BackgroundGhodke PS, Shete D, Anap D. Prevalence of sacroiliac joint dysfunction in postpartum women-a cross sectional study. Physiother Rehabil. 2017;2(3):149.
- Individual participant dataSharing planned: Undecided
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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 Cesarean and Vaginal Birth Complications, run by South Valley University at 1 site in Egypt.
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 5 inclusion and 3 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 2 Oct 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 Egypt. 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?
Lumbar Spine Extension Active Range of Motion (time frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05538325, which also lists 8 linked publications.
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 2 Oct 2025.