No registrations found.
ID
Source
Brief title
Health condition
misoprostol, incomplete evacuation, curettage, expectant management
misoprostol, zwangerschapsrest, curettage, expectatief beleid
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sonographic finding of empty uterus (max diameter of uterine contents < 10mm); 6 weeks after randomization.
Secondary outcome
1. Quality of Life (measured with SF-36 and HADS): baseline, 1-2 weeks, 4 weeks and 3 months after randomization;
2. Recovery specific Quality of Life: measured with RI-10 4 weeks after randomization, and EuroQol 3 months after randomization;
3. Number of out-of-protocol visits in the 3 months after randomization;
4. Numer of (re)interventions in the 3 months after randomization;
5. Pregnancy rates after 12 months.
Background summary
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.
Study objective
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.
Study design
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.
Intervention
1. Curettage;
2. Expectant management.
Inclusion criteria
1. First trimester miscarriage treated with misoprostol;
2. Sonographic evidence of remnant at follow-up 1-2 weeks after initial treatment.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3166 |
| NTR-old | NTR3310 |
| CCMO | NL38637.018.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39356 |