Research with human participants

Overview of medical research in the Netherlands

Pilotstudy on effect of hysteroscopic resection treatment of patients with abnormal uterine bleeding and a scardefect after a cesarean section

Published:
Last updated:

To study if a hysteroscopic resection a safe and effective treatment is for intermittend/post menstrual bloodloss or spotting.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Menstrual cycle and uterine bleeding disorders
Study type
Interventional

ID

NL-OMON32934

Source

ToetsingOnline

Brief title

HysPAS

Condition

  • Menstrual cycle and uterine bleeding disorders

Synonym

intermittend bleeding, spotting

Research involving

Human

Sponsors and support

Primary sponsor :
Sint Antonius Ziekenhuis
Source(s) of monetary or material Support :
stichting nieuwegyn

Intervention

Keyword :
abnormal uterine bleeding, hysteroscopy, section scar, therapy

Outcome measures

Primary outcome

decrease in days of post menstrual bloodloss

Secondary outcome

decraese dysmenorrhia

Increase of Quality of live(measured by SF -36 questionnaire)

Background summary

The cesarean section rate is rising. Patients with a history of a cesarean
section can have intermenstrual bloodloss and spotting after the menstruation
due to a cesarean scar defect in the uterus. There is no evidence based therapy
for this problem at the moment.

Study objective

To study if a hysteroscopic resection a safe and effective treatment is for
intermittend/post menstrual bloodloss or spotting.

Study design

prospective cohort study

Intervention

Hysteroscopic resection of scarred tissue in the anterior wall of the cervical
canal.

Study burden and risks

Patients undergo a hysteroscopic resection of scarred tissue in daycare. The
risk for perforation is being reduced by use of a ultrasound at the same time.
3 times the patients fullfil a questionnaire about quality of live (SF-36) ,
about contraception and obstetric hystory and about menstruation. They keep a
menstruatrion record 3 times for 2 months

Public
Sint Antonius Ziekenhuis

Koekoekslaan1
3430 EM Nieuwegein
NL
Scientific
Sint Antonius Ziekenhuis

Koekoekslaan1
3430 EM Nieuwegein
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

abnormal menstrual bleeding, intermittend bleeding or prolonged menstruation
history of cesarean section
scardefect seen by SIS or GIS
18 years of older
Dutch speaking and reading

Exclusion criteria

pregnancy or wish to become pregnant in future
presence of contra-indication for anaesthesia or hysteroscopy
(uncontrolled)endocrinological disorder
other gynaecologic pathology
use of coagulantia

Design

Study type :
Interventional
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
22
Type :
Actual

Medical products/devices used

Registration
:
No

Approved WMO
Date :
Application type :
First submission
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

ID: 26833
Source: NTR
Title: Studie naar hysteroscopische behandeling van littekendefecten na sectio bij patienten met abnormaal uterien bloedverlies.

In other registers

Register ID
ClinicalTrials.gov NCT1922
CCMO NL28897.100.09