NCT03881215

Brief Summary

Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

3.9 years

First QC Date

March 16, 2019

Last Update Submit

January 26, 2020

Conditions

Intra-uterine Adhesions

Outcome Measures

Primary Outcomes (1)

  • Incidence of adhesion recurrence

    recurrence of severe intra-uterine adhesions

    3 months

Secondary Outcomes (2)

  • Days of menses

    3 months

  • Amount of menses

    3 months

Study Arms (2)

Platelet Rich Plasma

EXPERIMENTAL

PRP

Procedure: Platelet Rich PlasmaProcedure: intra-uterine balloon

intra-uterine balloon

ACTIVE COMPARATOR
Procedure: intra-uterine balloon

Interventions

Platelet Rich PlasmaPROCEDURE

Platelet Rich Plasma

Platelet Rich Plasma
intra-uterine balloonPROCEDURE

intra-uterine balloon

Platelet Rich Plasmaintra-uterine balloon

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-40 years
  • Grade III intra-uterine adhesions

You may not qualify if:

  • Age \< 18 or \> 40 years.
  • Hb \< 11 g/dL, platelets \< 150.000/mm3.
  • Patient taking anticoagulant.
  • Patient taking NSAID in the 10 days before procedure.
  • Any significant comorbidity or psychiatric disorder that would compromise patient's consent.
  • Active cervical or uterine infection.
  • Undiagnosed genital bleeding.
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 16, 2019

First Posted

March 19, 2019

Study Start

January 1, 2016

Primary Completion

December 10, 2019

Study Completion

January 10, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)