What should be done in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage? An analysis of costs and effects.
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Miscarriage is a frequent complication in first trimester pregnancy which occurs in 10-15% of pregnant women. Only recently, medical treatment with misoprostol has been introduced as a non-invasive and inexpensive new treatment option. A strategy starting with misoprostol is effective in 50-80% of women with miscarriages. Although misoprostol is being used ever more frequently, the sonographic image of incomplete evacuation still leads to additional surgery, i.e. curettage. There is no doubt that curettage is an effective treatment for women with an incomplete miscarriage. However, it is unknown whether curettage is also cost effective in asymptomatic women with sonographic evidence of incomplete evacuation after primary misoprostol treatment for miscarriage.
What is, in women with suspected incomplete evacuation of a miscarriage after misoprostol based on real-time 2D sonography:
- the effectiveness of expectant management relative to curettage
- the generic quality of life QOL (SF-36, euroqol) of curettage versus expectant management
- the cost of curettage versus expectant management
- patients' preferences for curettage versus expectant management
Knowledge on these four dimensions will be integrated in the cost-effectiveness analysis.
CURETTAGE: Evacuation of the uterus is performed by suction curettage under general or regional anaesthesia in a day-care setting within three days after randomization. Transvaginal sonographic examination is scheduled six weeks after randomization.
EXPECTANT MANAGEMENT: Consultation by telephone two weeks after randomization, Vaginal ultrasound is scheduled six weeks after randomization.In case of persisting abnormalities at this sonographic examination, women will be scheduled for curettage. In case of severe complaints, defined as heavy vaginal bleeding or severe abdominal pain, an emergency curettage will be performed.
PRIMARY OUTCOME: The sonographic finding of an empty uterus (max diameter of any contents of the uterine cavity <10mm) will serve as the primary endpoint.
Quality of life measured with the SF-36 and the HADS (Hospital Anxiety and Depression Scale) at baseline, 1-2 weeks, 4 weeks and 3 months after randomization.
Recovery specific QoL; 4 weeks after randomization), euroQoL at 3 months after randomization. Also,he number of out-of-protocol visits to the outpatient clinic, and the type and number of any
re-interventions during the first three months will be compared between treatment arms.
The sample size was also calculated for the QOL (SF 36, measured 4 times during the first 3 months after randomization, using GEE analyses), according to a non-inferiority design. A difference of 10 points per scale was considered to be clinically relevant. With a standard deviation of 20, a type I error of 0,05, and 80% power, 65 patients will be needed per treatment arm. Thus, randomisation of 162 women will be sufficient.
Drs. Marianne Verschoor Drs. Marike Lemmers
AMC Amsterdam / Amphia Breda AMC Amsterdam/Flevoziekenhuis