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Misorest

 

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.

 

Go to the Misorest website.

 

Rationale

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.
 

 

Objective
To compare effectiveness and costs between curettage and expectant management in symptom free women with sonographic evidence of incomplete evacuation of a miscarriage after primary misoprostol treatment. We aim to answer the following specific questions:

 

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.


Study design
Multicentre randomized clinical trial with a cost-effectiveness analysis alongside it.

Study population
We will study patients with sonographic evidence of incomplete evacuation of the uterus, after having been treated primarily with misoprostol for a first trimester miscarriage.

Intervention

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.

 

Outcome measures

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.

 

SECONDARY OUTCOME:

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.


Power/data analysis
Anticipating a 97% success rate with curettage, versus 85% for expectant management, we would need to randomize 162 patients on a 1:1 basis to have a power of 0.80 in excluding that expectant management leads to a 20% lower success rate, using the z-test statistic with continuity correction at a 5% significance level.  

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.


Economic evaluation
We will perform a cost-effectiveness analysis alongside the clinical trial. Analysis will be carried out from the societal perspective.

Time schedule
The first 3 months will be used to get the project on track: obtaining ethical approval, building a database, designing case record forms and organising other infrastructural prerequisites. Patients will be included from month 4 onwards, up to month 34. With a time horizon of 3 months all patients will have finished treatment after 36 months. Evaluation of pregnancies after the index miscarriage will be evaluated during the first year after inclusion. This evaluation will stretch beyond the time frame of this grant application, and will be funded otherwise.

 

Projectleader
Dr. W.M. Ankum, gynecologist, AMC


Subsidy
ZonMW 80-82310-97-12066

 

Contact

Drs. Marianne Verschoor                    Drs. Marike Lemmers

AMC Amsterdam / Amphia Breda     AMC Amsterdam/Flevoziekenhuis

06-12518820                                        06-13227143

misorest@studies-obsgyn.nl