NCT07761741

Brief Summary

Objective of the study is to investigate the effect of adding manual lymphatic drainage massage to classical therapeutic exercises on resolving physiological lower limbs edema in late pregnancy women. The main question to be answered by this study: Does adding manual lymphatic drainage massage to classical therapeutic exercises have effect on resolving physiological lower limbs edema in late pregnancy ? Researchers will compare 2 groups of 60 participants group A (study group) will include participants who will join a physiotherapy plan of care in the form of sessions compose of manual lymphatic drainage massage technique with specific therapeutic exercise as well as wearing compression garments and advice. While, group B will involve control participants who will follow routine care and advice as well as wearing the same compression garments as group A participants.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Aug 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Aug 2026Oct 2026

First Submitted

Initial submission to the registry

August 8, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

August 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 8, 2026

Last Update Submit

August 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ankle and foot circumference

    2 month

Study Arms (2)

No Intervention

PLACEBO COMPARATOR
Other: Control group

Intervention group

EXPERIMENTAL
Other: manual lymphatic drainage massage technique with specific therapeutic exercise

Interventions

Physiotherapy plan of care in the form of sessions compose of manual lymphatic drainage massage technique with specific therapeutic exercise as well as wearing compression garments and advice.

Intervention group

Wearing the same compression garments as group A participants.

No Intervention

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • a total of 60 women will be recruited from the Antenatal Clinic of Beni-Suef University Hospital, Beni-Suef, Egypt. Their ages will be ranged from 25-35 years and their body mass index (BMI) will be ranged from 30-35 kg/m2. All participants are pregnant women at 3rd trimester of pregnancy 28-32 weeks' of gestation diagnosed with late pregnancy physiological lower limbs edema

You may not qualify if:

  • Women will be excluded from the study, if they were diagnosed with any risk pregnancy conditions such as pre-eclampsia, heart diseases, gestational diabetes mellitus respiratory diseases causing excessive coughing or sneezing, chronic physical or mental illness, other pain conditions, coagulation disturbances, had any medical condition that would or failed to complete an informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of physical therapy for Woman's Health

Study Record Dates

First Submitted

August 8, 2026

First Posted

August 12, 2026

Study Start

August 8, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08