Skip to content

Het voorkomen van littekenvorming in de baarmoeder bij vrouwen die een curettage ondergaan vanwege een miskraam. (Evaluatie van anti-verklevingsmiddel).

Post Abortion Prevention of Adhesions: Evaluation of hyaluronic acid, hyalobarier gel endo.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22431
Enrollment
150
Registered
2011-10-27
Start date
2011-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Approximately 15-20 % of all clinically recognized pregnancies in women of reproductive age will end in a miscarriage. A possible complication of surgical treatment is intrauterine adhesion (IUA) formation or Asherman syndrome. IUA can be asymptomatic but often results in symptoms. Recurrent curettage, defined as one or more curettage in history, is a risk factor for IUA formation. Application of hyaluronic acid, a physical barrier has shown to be effective in prevention or reduction of adhes

Interventions

Patients will be randomised and allocated to curettage with adhesion prevention (hyaloronic) group or curettage alone (control) group. Hyaloronic acid will be applied intrauterine once, immediately af

Sponsors

Sint Lucas Andreas ziekenhuis
Lead Sponsor

Eligibility

Inclusion criteria

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 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

Exclusion criteria: 1. Patients with a suspected mola pregnancy; 2. Patients with a previous hysteroscopic surgery (endometrial ablation, removal of fibroids or surgical correction of congenital uterine anomalies); 3. Patients with contra-indications for one of the procedures at the time of randomisation; 4. Patients who do not master the Dutch or English language; 5. Patients who are younger than 18 years of age or mentally incompetent; 6. Patients with severe signs of infection (sepsis).

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is number of patients with intra-uterine adhesions during the follow-up hysteroscopy.

Secondary

MeasureTime frame
1. Severity of intra-uterine adhedsions (IUAs); 2. Time to conceive during one year; 3. Number and time to clinical pregnancy during one year; 4. Number and time to ongoing pregnancy during one year; 5. Number of miscarriages during the first year after curettage.

Contacts

Public ContactA.B. Hooker

Sint Lucas Andreas Ziekenhuis Jan Tooropstraat 164

a.hooker@slaz.nl+31 (0)20 5108911

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)