NCT07265440

Brief Summary

The goal of this clinical trial is to learn if our new specialized technique using effleurage massage works to prevent striae gravidarum in primigravida. The main questions it aims to answer are: Can our new specialized technique using effleurage massage prevent or even decrease the severity of striae gravidarum in primigravida ? What side effects may participants face when using our technique? Participants will: perform effleurage massage in transverse direction from medial to lateral only not back and forth, twice a day starting from the 17th week until the 28th week of pregnancy and three times a day starting from the 28th week of pregnancy for 10 minutes for each time until date of birth but from lateral to medial. It will be performed on the whole abdominal area extending from the diaphragm to the pupic area, also on both sides of the abdomen extending from the 12th rib to the iliac crest.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 9, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 22, 2025

Last Update Submit

December 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction in Striae Gravidarum severity

    Severity of striae gravidarum will be assessed using INA score at three time points during pregnancy to evaluate progression and response to the intervention

    At 21 weeks of gestation, 29 weeks of gestation ,and 39 weeks of gestation

Study Arms (2)

Efficacy of EM on SG

ACTIVE COMPARATOR

Each patient in this group will perform effleurage massage in transverse direction from medial to lateral only not back and forth, twice a day starting from the 17th week until the 28th week of pregnancy and three times a day starting from the 28th week of pregnancy for 10 minutes for each time until date of birth but from lateral to medial. It will be performed on the whole abdominal area extending from the diaphragm to the pupic area, also on both sides of the abdomen extending from the 12th rib to the iliac crest.

Other: New specialized technique using effleurage massage

Efficacy of olive oil only on SG

ACTIVE COMPARATOR

They will apply olive oil only twice a day starting from the 17th week until the 28th week of pregnancy and three times a day starting from the 28th week of pregnancy until date of birth .

Other: New specialized technique using effleurage massage

Interventions

effleurage massage was performed in transverse direction from medial to lateral only not back and forth, twice a day starting from the 17th week until the 28th week of pregnancy and three times a day starting from the 28th week of pregnancy for 10 minutes for each time until date of birth but from lateral to medial. It will be performed on the whole abdominal area extending from the diaphragm to the pupic area, also on both sides of the abdomen extending from the 12th rib to the iliac crest.

Efficacy of EM on SGEfficacy of olive oil only on SG

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All females will be primigravida.
  • All females will be at the 17th week to the 20th week of gestation.
  • Age of participants will range from 20-30 years.
  • Their BMI will not exceed 28 kg/m.

You may not qualify if:

  • Any dermal pathology.
  • Psychiatric disorders.
  • Skin tumor.
  • Pregnant with more than one child.
  • History or symptoms of premature birth.
  • Placental abruption.
  • History of abdominal surgeries.
  • History of abdominal hernia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Clinics, Faculty of Physical Therapy, Kafrelsheikh University, Egypt

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

Location

MeSH Terms

Conditions

Striae Distensae

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior physical therapist in physical therapy for woman health Department, Sidi-Salem Hospital, Kafrelsheikh, Egypt

Study Record Dates

First Submitted

November 22, 2025

First Posted

December 4, 2025

Study Start

October 9, 2024

Primary Completion

January 12, 2025

Study Completion

May 30, 2025

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared. This study involves sensitive participant information and there is no plan for data sharing.

Locations