NCT04125498

Brief Summary

This study aims to examine the effects of an osteopathic treatment on adhesions related to c-sections scars.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2021

Enrollment Period

5.8 years

First QC Date

October 10, 2019

Last Update Submit

March 21, 2022

Conditions

Cesarean Section ComplicationsCesarean Section; Complications, Wound, Infection (Following Delivery)

Keywords

adhesionscicatrixc-sectionscarmanual treatment

Outcome Measures

Primary Outcomes (3)

  • Adhesions' number, size and vascularization

    Evaluate through superb microvascular imaging. Correlation between adhesions and type/number of c-section

    Changes from Baseline Adhesions' number, size and vascularization at 2 weeks and one month

  • Adverse event

    Number and type of adverse events

    Number of adverse event occurred at one month

  • Uterine niches

    Evaluation of the presence and dimensions of uterine niches

    Changes in dimension of uterine niches at one month

Secondary Outcomes (4)

  • Reliability of osteopathic palpation through a questionnaire

    At one week, two week and one month

  • Inter-reliability of ultrasound evaluation

    At one week, two week and one month

  • Self-massage compliance

    At one month

  • Symptoms related to scar

    At one week, two week and one month

Study Arms (4)

OMT

ACTIVE COMPARATOR

Osteopathic manual treatment

Other: Osteopathic treatment

OMT plus self-massage

ACTIVE COMPARATOR

Patients will be submitted to OMT and then they will be invited to practice a self-massage at home.

Other: Osteopathic treatmentOther: Self-massage

Placebo

SHAM COMPARATOR

Similar to OMT without pressure.

Other: Placebo treatment

Placebo plus self-massage

ACTIVE COMPARATOR

Patients will be submitted to placebo manual treatment and then they will be invited to practice a self-massage at home.

Other: Placebo treatmentOther: Self-massage

Interventions

Osteopathic treatmentOTHER

Manual treatment that aims to release myofascial tensions

OMTOMT plus self-massage
Placebo treatmentOTHER

Similar to OMT without pressure

PlaceboPlacebo plus self-massage
Self-massageOTHER

Women will be instructed to perform self-massage at home once a day for 5 minutes.

OMT plus self-massagePlacebo plus self-massage

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen underwent to a c-section
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • primiparous or multipara who have undergone a cesarean section with a completely healed scar will be included.
  • women who had first menstruation after childbirth
  • Women with or without pain or symptoms related to scarring or the presence of isthmocele will be included.

You may not qualify if:

  • caesarean section performed in a period less than 6 months and over 3 years
  • uterine prolapse
  • scar treatments already performed (both manual and medical)
  • absence of scar adhesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Studio Osteopatico Busto Arsizio

Busto Arsizio, Varese, Italy

Location

MeSH Terms

Conditions

Wounds and InjuriesInfectionsTissue AdhesionsCicatrix

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Carolina Lavazza, MSc

    Studio Osteopatico Busto Arsizio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The gynecologist, the radiologist and the statistician will be blinded to group allocation. Participants will have similar manual treatments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized triple-blinded
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 14, 2019

Study Start

December 1, 2019

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

April 1, 2022

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)