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Recruiting NCT06976164

Reflexo Therapy for Gestational Diabetes Mellitus

No phase Interventional Physical Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The standard antenatal care., Foot reflexology..
Who it may be relevant to
Registry conditions: Physical Therapy. Basic parameters: 20 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effects of Reflexo Therapy of Sole on Gestational Diabetes Mellitus

Overview

The purpose of this study will be to detect the effects of Reflexo therapy of sole on GDM.

Detailed description

Gestational diabetes mellitus is considered a hazard factor for antenatal complications for both mother and fetus. It is characterized by glucose intolerance of variable degrees with the beginning or first recognition of pregnancy. It affects 14% of pregnancies worldwide, and it undergoes continuous changes in the diagnostic criteria, ethnicity and the population studied.

There is an increasing prevalence of diabetes mellitus, and its major metabolic disorder caused by the insulin secretion defect or insulin action defect resulting from a defect in insulin secretion, insulin action, or both. As a result, it will lead to chronic hyperglycemia associated with carbohydrates, protein, and fat disturbance.

In spite of the fact that the reason for gestational diabetes mellitus is still not fully understood, it is proposed that human placental lactogen has growth hormone-like actions, and that it causes lipolysis and thus increases the levels of circulating fatty acids that repress the action of insulin and cause insulin resistance in pregnant females which appear to play a crucial role in the pathogenesis of gestational diabetes mellitus.

Interventions

  • Procedure The standard antenatal care.
    Antenatal Protocol.
  • Procedure Foot reflexology.
    A manual therapy technique.

Primary outcome measures

  • Change in The Oral Glucose Tolerance Test. [Time frame: Change from Baseline Oral Glucose Tolerance Test at one month]
  • Change in The Hemoglobin A1C Test. [Time frame: Change from Baseline Hemoglobin A1C Test at one month]

Eligibility criteria

Inclusion criteria

  • They were maternally aged between 20 and 35 years.
  • The gestational age ranged from between 24 and 36 weeks.
  • Their BMI didn't exceed 30 kg/m2.
  • A singleton live fetus and not under stressful event.

Exclusion criteria

  • They had high-risk pregnancies.
  • Bad obstetric situations.
  • Diseases that could interfere with participation.
  • Smoking.
  • Oral sedative administration.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 2 centers
  • The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University. — Cairo
  • The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University. — Cairo

Identifiers

NCT: NCT06976164 · P.T. 2024-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗