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MisoREST: What schould be done in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage?


- candidate number11232
- NTR NumberNTR3310
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-feb-2012
- Secondary IDsNL38637.018.11 / 2011/373; CCMO / METC AMC
- Public TitleMisoREST: What schould be done in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage?
- Scientific TitleMisoREST: A multicenter randomized controlled trial comparing curettage and expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage.
- ACRONYMMisoREST
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedMisoprostol , Curretage, Incomplete evacuation, Expectant management
- Inclusion criteria1. First trimester miscarriage treated with misoprostol;
2. Sonographic evidence of remnant at follow-up 1-2 weeks after initial treatment.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2012
- planned closingdate31-dec-2014
- Target number of participants162
- Interventions1. Curettage;
2. Expectant management.
- Primary outcomeSonographic finding of empty uterus (max diameter of uterine contents < 10mm); 6 weeks after randomization.
- Secondary outcome1. 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.
- TimepointsPrimary 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.
- Trial web sitewww.studies-obsgyn.nl/misorest
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMw. drs. M.A.C. Verschoor
- CONTACT for SCIENTIFIC QUERIESProf. B.W.J. Mol
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryObjective 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.
- Main changes (audit trail)
- RECORD27-feb-2012 - 3-jan-2017


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