The primary study question is phrased as a non-inferiority hypothesis of expectant management versus curettage. Curettage is expected to lead to a higher proportion of patients succesfully treated, but we anticipate that women will prefer expectant…
ID
Bron
Verkorte titel
Aandoening
misoprostol, incomplete evacuation, curettage, expectant management
misoprostol, zwangerschapsrest, curettage, expectatief beleid
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Sonographic finding of empty uterus (max diameter of uterine contents < 10mm); 6 weeks after randomization.
Achtergrond van het onderzoek
Objective of the MisoREST trial: To assess the effects of curettage versus expectant management in women with incomplete evacuation of the uterus after treatment with misoprostol for first trimester miscarriage.
Doel van het onderzoek
The primary study question is phrased as a non-inferiority hypothesis of expectant management versus curettage. Curettage is expected to lead to a higher proportion of patients succesfully treated, but we anticipate that women will prefer expectant management if the proportion of succes is not substantially lower.
Onderzoeksopzet
Primary outcome (sonographic finding of empty uterus): 6 weeks.
Secondary outcomes:
1. Quality of life: baseline, 1-2 weeks, 4 weeks and 3 months;
2. Out-of-protocol visits: 3 months;
3. (Re)interventions: 3 months;
4. Pregnancy rates: 12 months.
Onderzoeksproduct en/of interventie
1. Curettage;
2. Expectant management.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. First trimester miscarriage treated with misoprostol;
2. Sonographic evidence of remnant at follow-up 1-2 weeks after initial treatment.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Age < 18 years;
2. Severe vaginal bleeding;
3. Severe abdominal pain;
4. Fever (> 38.0) or sepsis requiring antibiotic treatment and curettage;
5. Failed misoprostol-induced miscarriage: sonigraphic finding of intact gestational sac still in situ.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3166 |
| NTR-old | NTR3310 |
| CCMO | NL38637.018.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39356 |