NCT06530173

Brief Summary

• To improve the quality of pregnant women's lives and provide better control for pregnancy-associated symptoms.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2024

Status
not yet 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

First Submitted

Initial submission to the registry

July 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 27, 2024

Last Update Submit

July 27, 2024

Conditions

Low Back Pain

Keywords

low back pain in pregnancystria gravidraum

Outcome Measures

Primary Outcomes (1)

  • Relationship Between Striae Gravidarum and Low-Back Pain Among Pregnant Women

    • To assess the association between the presence and severity of striaegravidarum and low back pain among pregnant women

    Baseline

Secondary Outcomes (1)

  • • To determine the prevalence of low back pain among pregnant women.

    Baseline

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All healthy pregnant women presenting to the Antenatal care clinic for routine antenatal care visits will be subjected to enrollment.

You may qualify if:

  • Adult (\>18 years) primigravida at 36-37 weeks of gestation. Uncomplicated singleton pregnancy.

You may not qualify if:

  • Women with multiple pregnancies.
  • Women having any signs of labor; including detected uterine contractions, rupture of membranes, or cervical dilatation.
  • Women with any systemic disease, such as gestational diabetes or preeclampsia.
  • Women using any medications during pregnancy, except for iron and vitamins supplements.
  • Women using preventive topical treatment for striaegravidarum.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sayed Mostafa, Prof

    STUDY CHAIR

  • Ahmed Abbas, Associate Prof

    STUDY DIRECTOR

  • Mohamed Shahat, Lecturer

    STUDY DIRECTOR

Central Study Contacts

Ereen Samir, Resident

CONTACT

01283115083ereensamir530@gmail.com

Ereen Roshdy, Resident

CONTACT

01283115083ereensamir530@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ereen Samir Roshdy

Study Record Dates

First Submitted

July 27, 2024

First Posted

July 31, 2024

Study Start

August 1, 2024

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

July 31, 2024

Record last verified: 2024-07