The goal of the study is to determine if the use of Hyalobarrier® Endo prevents or reduces the chance of adhesions. We also would like to know how many woman become pregnant within the year and how the pregnancy goes.
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Presence and extent of adhesions in patients after recurrent curettage,
evaluated by hysteroscopy 8-12 weeks after the initial procedure, using the
ESGE classification.
Secondary outcome
Hazzard ratio for an ongoing pregnancy (in those patients willingly to
conceive) after one year follow-up. Pregnancy and miscarriage rate one year
after the procedure, complication during the procedure, any side-effect, number
of performed re-interventions during one year.
Background summary
A rare occuring complication with curettage is the development of intra-uterine
adhesions; the syndrome of Asherman. In serious cases the menstual blood cannot
go out as a result of the adhesions. Fertility problems can also occur, because
no implantation can occur. Recent research shows that women that undergo more
than one curettage have a higher risk in forming adhesions. Because of the
detrimental effects of the adhesions it is important to prevent this.
Study objective
The goal of the study is to determine if the use of Hyalobarrier® Endo prevents
or reduces the chance of adhesions. We also would like to know how many woman
become pregnant within the year and how the pregnancy goes.
Study design
If a patient takes part in this study she will be randomised in one of the two
groups:
A curretage will be done:
1. In the uterus Hyalobarrier® Endo will be placed
OR
2. No agent will be inserted.
Intervention
In half of all subjects after the curettage the agent in the uterus
Hyalobarrier® Endo will be placed
Study burden and risks
Applications of hyaluronic acid has shown to be a safe procedure; no potential
risk has been reported since it*s introduction. Potential risks of curettage
are bleeding, perforation of the uterus wall, infection and induction of
intra-uterine adhesions.
Additional, patients are asked to fill in questionnaires (approximately 15
questions) 3, 6 and 12 months after the procedure.
de Boelelaan 1117
AMSTERDAM 1081 HV
NL
de Boelelaan 1117
AMSTERDAM 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Consented patients, who had at least one previous suction or abrasive (blunt or sharp) curettage for a miscarriage in the history, visiting the outpatient clinic with a miscarriage or termination of pregnancy and planned for curettage, will be included in the study. The ultrasound is a key in the diagnosis of miscarriage; at least one recent ultrasound examination (made within 7 days before randomisation) is required for inclusion. The maximum gestational age at inclusion is 14 weeks.
Exclusion criteria
- Patients with a suspected mola pregnancy.
- Patients with a previous hysteroscopic surgery (endometrial ablation, removal of
fibroids or surgical correction of congenital uterine anomalies)
- Patients with contraindications for one of the procedures at the time of randomisation
- Patients who do not master the Dutch or English language.
- Patients who are younger than 18 years of age or mentally incompetent.
- Patients with severe signs of infection (sepsis).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35693.029.11 |