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Low Back PainNCT06530173

Relationship Between Striae Gravidarum and Low-Back Pain Among Pregnant Women: a Cross-Sectional Study

An observational study of Low Back Pain, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To improve the quality of pregnant women's lives and provide better control for pregnancy-associated symptoms. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Low Back Pain
How many people
234 participants
Where
No sites listed yet
Study dates
Aug 2024to Dec 2025
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 45 years
  • Women only
  • Adult

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

Who may be able to join

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

Who cannot join

  • • 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.

Trial locations and contacts

No sites are listed yet.

Ereen Samir, Resident contact

01283115083

ereensamir530@gmail.com

Ereen Roshdy, Resident contact

01283115083

ereensamir530@gmail.com

About this study

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

Women commonly experience low back pain (LBP) during pregnancy, and its severity tends to increase as the pregnancy advances. The reported prevalence of LBP among pregnant women varies widely within the literature, ranging from 20% up to 90%(Katonis et al., 2011; Liddle \& Pennick, 2015). This is mostly owing to the different definitions and diagnostic criteria of LBP and thus, its real prevalence is still undetermined. In Africa, LBP was found to affect around 50% of pregnant women(Jimoh et al., 2013; Oyeyemi et al., 2013); however and to our knowledge, the prevalence of this condition in Egypt has not been previously described.

Although the occurrence of LBP in pregnancy is typical and would spontaneously resolve after delivery; yet, LBP can be severe enough to negatively impact the quality of pregnant women's lives and increase the health cost burden on them and on the community as well(Kokanali \& Caglar, 2019). Furthermore,such a condition can affect women's ability to effectively fulfill their work duties and increase the work loss due to them taking sick leaves or even quitting their jobs(Sencan et al., 2018). Therefore, it is very essential to make every effort not only to reduce such pain, but also to identify itsetiology in order to prevent its occurrence. Although smoking, high body mass index (BMI) and increased workload have been found to be associated with LBP; however, the exact cause of LBP remains unclear(Katonis et al., 2011; Liddle \& Pennick, 2015; Sabino \& Grauer, 2008).

On the other hand, striaegravidarum (SG) is another common condition found in pregnancy, affecting 55-90% of pregnant women. SG is typically found after the 24th week of gestation as atrophic linear scars on the breasts, abdomen, buttocks, hips, and thighs (Chang et al., 2004; Farahnik et al., 2017). These lesions can cause serious cosmetic problems and pose a psychological burden on pregnant women (Korgavkar \& Wang, 2015). Similarly to LBP, the underlying etiology of such a condition is stillunknown. Yet, some have identified several factors that increase its risk, such as young age, large fetus, increased weight gain and high BMI (Farahnik et al., 2017; Korgavkar \& Wang, 2015; Picard et al., 2015).

Interestingly, some have suggested thatan interaction between hormonal and mechanical factors as the underlying mechanismof SG formation. At first, the hormonal changes associated with pregnancy may weaken the connective tissue in the skin. Then, as the pregnancy progresses, the resulting mechanical stretching may add to this weakening and result inSG(Farahnik et al., 2017; Korgavkar \& Wang, 2015). In a similar manner, the weakening of the connective tissue can affect the spine stability and thus, back pain starts to develop as the mechanical load related to pregnancy increases on the spine (Casagrande et al., 2015).

With that being said, an association between SG and LBP in pregnancy has been recently suggested in a Turkish study byKokanali \& Caglar (2019). They found that the presence of SG was more common and its severity was greater among pregnant women with LBP than among those without LBP. They also reported a positive correlation between SG and LBP severity.However, such an association has not been previously investigated among Egyptian women, and therefore, we will conduct this study in order to assessthe association between SG and LBP among pregnant women living in assuit, Egypt

Conditions
Low Back Pain
Keywords
low back pain in pregnancy, stria gravidraum
Medical subject headings
Low Back Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline

Secondary outcomes (1)
  1. • To determine the prevalence of low back pain among pregnant women.

    • To evaluate the effect of women's socio-demographic characteristics on the presence of striae gravidarum or low back pain.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2024
  2. Study startAug 2024 (estimated)
  3. Primary completionAug 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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 only
Time perspective
Cross-sectional
Enrolment
234 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06530173
Sponsor's protocol ID
Striae and Low-Back pain
Status last verified
Jul 2024
First submitted
27 Jul 2024
Last updated
31 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain, run by Assiut University.

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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ereen Samir, Resident (01283115083, ereensamir530@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relationship Between Striae Gravidarum and Low-Back Pain Among Pregnant Women (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 31 Jul 2024.

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