early pregnancy failure miscarriage
Conditions
Interventions
After randomization at day 1 :
- Mifepristone 600mg in the intervention group
- placebo in the control group
followed by the standard treatment with misoprostol : two doses of 400ug orally
at da
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Early pregnancy failure, 6-14 weeks postmenstrual with a o Crown-rump length * 6mm and no cardiac activity OR o Gestational sac without embryonic pole, confirmed by a second ultrasound at least one week later * At least one week after diagnosis OR a discrepancy of at least one week between crown-rump length and calendar gestational age * Intra-uterine pregnancy * Women aged above 18 years * Hemodynamic stable patient * No signs of infection * No signs of incomplete abortion * No contraindications for mifepristone or misoprostol * No high risk of thrombosis
Exclusion criteria
Exclusion criteria: Patient does not meet inclusion criteria, discovered after randomization Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be complete evacuation of the products of conception from the uterus, which is determined by routinely ultrasonography six to nine days after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are patient satisfaction, side effects and complications. | — |
Countries
Netherlands
Outcome results
None listed