NCT07851753

Brief 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?

Trial Health

77
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
May 2026Dec 2026

Study Start

First participant enrolled

May 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 26, 2026

Last Update Submit

September 26, 2026

Conditions

Keywords

pregnancycore stabilityfemalegestational diabeteshuman

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    12th week

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsgestational diabetes
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant female with and without gestational diabetes

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ganga Ram Hospital, Fatima Memorial Hospital, Gulab Devi Hospital

Lahore, Punjab Province, 6400, Pakistan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 34884524BACKGROUND
  • Moon 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.

    PMID: 35135076BACKGROUND
  • Chauhan 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.

    PMID: 36426343BACKGROUND
  • Das 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.

    BACKGROUND
  • Ye J, Li J, Lin Y, Wang Y, Wu J, Zhou Z. Pregnancy: A Comprehensive Review. 2024.

    BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • hina gul gul

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

imran Professor, Faculty of Rehabilitation & Allied Health Sciences, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2026

First Posted

October 1, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations