To assess costs and effects of curettage versus expectant management in women with incomplete evacuation of a miscarriage, as diagnosed with sonography, after misoprostol.
ID
Source
Brief title
Condition
- Abortions and stillbirth
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the success rate in reaching an empty uterus, as
substantiated by normal sonographic findings.
Secondary outcome
Secondary outcomes are Quality of Life scores assessed with the SF-36, the need
of additional treatments, complications, quality of recovery pain and costs.
Background summary
Recent studies have shown that in women with miscarriage misoprostol is a
cost-effective alternative for immediate curettage. A problem with misoprostol
is that after initial treatment, sonographic findings during follow-up
frequently show incomplete evacuation of uterine contents, which often leads to
additional interventions, i.e. suction curettage, thereby limiting the benefits
of primary misoprostol treatment.
Study objective
To assess costs and effects of curettage versus expectant management in women
with incomplete evacuation of a miscarriage, as diagnosed with sonography,
after misoprostol.
Study design
Multicentre randomized clinical trial with a cost-effectiveness analysis
alongside it.
Intervention
Curettage versus expectant management.
Study burden and risks
Participants fill out questionnaires at five points in time, which will take
them about 5 minutes every time. Furthermore, a fingerstick will be performed
in order to determine Hb.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with a miscarriage treated with misoprostol, and sonographic evidence of remnant of the miscarriage at the follow-up visit 7 days after initial treatment.
Exclusion criteria
Women aged below 18 years
Women with severe vaginal bleeding
Women with severe abdominal pain
Women with fever (> 38.0) or sepsis requiring antibiotic treatment and curettage,
Women with contraindications for curettage
Women with a failed misoprostol-induced miscarriage, as substantiated by the sonographic finding of an intact gestational sac still in situ.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL38637.018.11 |
| OMON | NL-OMON28421 |