Reflexo Therapy for Gestational Diabetes Mellitus

NCT ID: NCT06976164

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Physical Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group A

Group Type EXPERIMENTAL

The standard antenatal care.

Intervention Type PROCEDURE

Antenatal Protocol.

Foot reflexology.

Intervention Type PROCEDURE

A manual therapy technique.

Experimental Group B

Group Type EXPERIMENTAL

The standard antenatal care.

Intervention Type PROCEDURE

Antenatal Protocol.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The standard antenatal care.

Antenatal Protocol.

Intervention Type PROCEDURE

Foot reflexology.

A manual therapy technique.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. They had high-risk pregnancies.
2. Bad obstetric situations.
3. Diseases that could interfere with participation.
4. Smoking.
5. Oral sedative administration.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yomna Ghanem

Demonstrator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University.

Cairo, , Egypt

Site Status RECRUITING

The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University.

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yomna E Ghanem, M.Sc.

Role: CONTACT

+201011501343

Fayiz F Elshamy, PhD

Role: CONTACT

+201091050154

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Eman A Elhosary, PhD

Role: primary

+201276754277

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P.T. 2024-2025

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.