Gestatiaonl Diabetes MellitusNCT07851753
Lumbopelvic Stability in Gestational Diabetes Mellitus
An observational study of Gestatiaonl Diabetes Mellitus, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of this comparative cross-sectional study is to learn about the effects of gestational diabetes on lumbopelvic stability in primigravida subjects. The main question it aims to answer is: Does gestational diabetes effect lumbopelvic stability during pregnancy? 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
- Gestatiaonl Diabetes Mellitus
- How many people
- 170 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2026to 1 Dec 2026
- 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: pregnant female with and without gestational diabetes
Who may be able to join
- Pregnant women (2nd trimester)
- Primi gravida
- Diagnosed cases of gestational diabetes mellitus (for case group)
- Healthy pregnant women (for control group)
- Singleton pregnancy
- Ability to perform functional tests (ASLR and Y Balance Test)
- BMI within normal to overweight range (e.g., 18.5-29.9 kg/m²)
- Stable medical condition
Who cannot join
- • High-risk pregnancy (e.g., preeclampsia, placenta previa)
- Previous spinal or pelvic surgery
- History of low back pain with neurological deficit
- Diagnosed spinal disorders (disc herniation, spondylolisthesis, severe scoliosis)
- Pelvic fractures
- Neurological disorders (e.g., stroke, neuropathy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
imran Professor, Faculty of Rehabilitation & Allied Health Sciences, PhD contact
Pakistan1 site, 1 recruiting
- Recruiting
Ganga Ram Hospital, Fatima Memorial Hospital, Gulab Devi Hospital
Lahore, Punjab Province, 6400
hina gul assistant professor, PhD*, 03214979172, hina.gul@riphah.edu.pk
Amna Tariq Khan, Urooj Ahmed DPT students, DPT
About this study
Official title: Comparison of Lumbopelvic Stability in Pregnant Women With and Without Gestational Diabetes Mellitus
The goal of this comparative cross-sectional study is to learn about the effects of gestational diabetes on lumbopelvic stability in primigravida subjects. The main question it aims to answer is:
Does gestational diabetes effect lumbopelvic stability during pregnancy?
Read the detailed description
This comparative cross-sectional study will be conducted over ten months at Fatima Memorial Hospital, Gulab Devi Hospital, and Ganga Ram Hospital. A total of 170 primigravida women in their second trimester (aged 20-40 years, singleton pregnancies, BMI 18.5-29.9 kg/m²) will be enrolled through non-probability convenient sampling and divided into two equal groups of 85 women each, with and without GDM. Women with high-risk pregnancies or spinal/pelvic comorbidities will be excluded. Lumbopelvic stability, dynamic balance, and pain intensity will be assessed by using the Active Straight Leg Raise (ASLR) test, Y-Balance Test (YBT), and Visual Analogue Scale (VAS), respectively, and data will be analyzed by using SPSS version 27.0.
- Conditions
- Gestatiaonl Diabetes Mellitus
- Keywords
- pregnancy, core stability, female, gestational diabetes, human
- Medical subject headings
- Diabetes, Gestational
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The Visual Analogue Scale (VAS) is a simple tool used to measure subjective pain intensity.It consists of a 10-cm (100-mm) horizontal line.
0 = No pain 10 (or 100 mm) = Worst pain imaginable The participant marks a point on the line representing their current pain intensity.
The distance from 0 to the participant's mark is measured and recorded as the pain score.
Measured: 12th week
Active Straight Leg Raise
The Active Straight Leg Raise (ASLR) test is a clinical test used to assess lumbopelvic load transfer and functional stability of the pelvis.
The participant lies supine with both legs straight. They actively raise one straight leg approximately 20 cm off the examination surface without bending the knee.
Difficulty or inability to perform the movement may indicate impaired lumbopelvic stability/load transfer.
It can be scored using a 0-5 difficulty scale, where higher scores indicate greater difficulty.
Measured: 12th week
Y-Balance Test (YBT)
The Y-Balance Test is a dynamic balance test used to assess postural control, functional stability, and lower-extremity/lumbopelvic control.
It requires the participant to maintain a single-leg stance while reaching the opposite leg in three directions:
Anterior Posteromedial Posterolateral
The reach distances are recorded and can be normalized to leg length to calculate a composite score.
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 May 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gestatiaonl Diabetes MellitusStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hina gul gul, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851753
- Sponsor's protocol ID
- REC/RCR&AHS/26/3003
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stern C, Schwarz S, Moser G, Cvitic S, Jantscher-Krenn E, Gauster M, Hiden U. Placental Endocrine Activity: Adaptation and Disruption of Maternal Glucose Metabolism in Pregnancy and the Influence of Fetal Sex. Int J Mol Sci. 2021 Nov 24;22(23):12722. doi: 10.3390/ijms222312722.
PubMed 34884524Moon JH, Jang HC. Gestational Diabetes Mellitus: Diagnostic Approaches and Maternal-Offspring Complications. Diabetes Metab J. 2022 Jan;46(1):3-14. doi: 10.4093/dmj.2021.0335. Epub 2022 Jan 27.
PubMed 35135076Chauhan A, Potdar J. Maternal Mental Health During Pregnancy: A Critical Review. Cureus. 2022 Oct 25;14(10):e30656. doi: 10.7759/cureus.30656. eCollection 2022 Oct.
PubMed 36426343Das S, Das N, Islam R, Harun J. Causes and Prevention of Maternal Complications During Pregnancy in Developing Countries. Asia Pacific Journal of Cancer Research. 2025;2:4-9.
Ye J, Li J, Lin Y, Wang Y, Wu J, Zhou Z. Pregnancy: A Comprehensive Review. 2024.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lumbopelvic Stability in Pregnant Women With and Without Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07851753
- Acronym / sponsor ID
- REC/RCR&AHS/26/3003
- Conditions
- Gestatiaonl Diabetes Mellitus
- Keywords
- pregnancy, core stability, female, gestational diabetes, human
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 Oct 2026 (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 goal of this comparative cross-sectional study is to learn about the effects of gestational diabetes on lumbopelvic stability in primigravida subjects. The main question it aims to answer is:
Does gestational diabetes effect lumbopelvic stability during pregnancy?
Detailed description
This comparative cross-sectional study will be conducted over ten months at Fatima Memorial Hospital, Gulab Devi Hospital, and Ganga Ram Hospital. A total of 170 primigravida women in their second trimester (aged 20-40 years, singleton pregnancies, BMI 18.5-29.9 kg/m²) will be enrolled through non-probability convenient sampling and divided into two equal groups of 85 women each, with and without GDM. Women with high-risk pregnancies or spinal/pelvic comorbidities will be excluded. Lumbopelvic stability, dynamic balance, and pain intensity will be assessed by using the Active Straight Leg Raise (ASLR) test, Y-Balance Test (YBT), and Visual Analogue Scale (VAS), respectively, and data will be analyzed by using SPSS version 27.0.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant female with and without gestational diabetes
Key inclusion criteria (8 listed)
- Pregnant women (2nd trimester)
Key exclusion criteria (6 listed)
- • High-risk pregnancy (e.g., preeclampsia, placenta previa)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analog Scale (VAS)
Time frame: 12th week
The Visual Analogue Scale (VAS) is a simple tool used to measure subjective pain intensity.It consists of a 10-cm (100-mm) horizontal line. 0 = No pain 10 (or 100 mm) = Worst pain imaginable The participant marks a point on the line representing their current pain intensity. The distance from 0 to the participant's mark is measured and recorded as the pain score.
Active Straight Leg Raise
Time frame: 12th week
The Active Straight Leg Raise (ASLR) test is a clinical test used to assess lumbopelvic load transfer and functional stability of the pelvis. The participant lies supine with both legs straight. They actively raise one straight leg approximately 20 cm off the examination surface without bending the knee. Difficulty or inability to perform the movement may indicate impaired lumbopelvic stability/load transfer. It can be scored using a 0-5 difficulty scale, where higher scores indicate greater difficulty.
Y-Balance Test (YBT)
Time frame: 12th week
The Y-Balance Test is a dynamic balance test used to assess postural control, functional stability, and lower-extremity/lumbopelvic control. It requires the participant to maintain a single-leg stance while reaching the opposite leg in three directions: Anterior Posteromedial Posterolateral The reach distances are recorded and can be normalized to leg length to calculate a composite score.
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 1 Oct 2026.
- Background: PubMed 34884524Stern C, Schwarz S, Moser G, Cvitic S, Jantscher-Krenn E, Gauster M, Hiden U. Placental Endocrine Activity: Adaptation and Disruption of Maternal Glucose Metabolism in Pregnancy and the Influence of Fetal Sex. Int J Mol Sci. 2021 Nov 24;22(23):12722. doi: 10.3390/ijms222312722.
- Background: PubMed 35135076Moon JH, Jang HC. Gestational Diabetes Mellitus: Diagnostic Approaches and Maternal-Offspring Complications. Diabetes Metab J. 2022 Jan;46(1):3-14. doi: 10.4093/dmj.2021.0335. Epub 2022 Jan 27.
- Background: PubMed 36426343Chauhan A, Potdar J. Maternal Mental Health During Pregnancy: A Critical Review. Cureus. 2022 Oct 25;14(10):e30656. doi: 10.7759/cureus.30656. eCollection 2022 Oct.
- BackgroundDas S, Das N, Islam R, Harun J. Causes and Prevention of Maternal Complications During Pregnancy in Developing Countries. Asia Pacific Journal of Cancer Research. 2025;2:4-9.
- BackgroundYe J, Li J, Lin Y, Wang Y, Wu J, Zhou Z. Pregnancy: A Comprehensive Review. 2024.
- 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.
imran Professor, Faculty of Rehabilitation & Allied Health Sciences, PhD contact
hina gul gul 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?
An observational study of Gestatiaonl Diabetes Mellitus, 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. 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?
Contact imran Professor, Faculty of Rehabilitation & Allied Health Sciences, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 12th 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?
On the ClinicalTrials.gov record for NCT07851753, which also lists 5 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 1 Oct 2026.