adhesions
Conditions
Interventions
In half of all subjects after the curettage the agent in the uterus
Hyalobarrier® Endo will be placed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
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 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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed