Early pregnancy failure. Miskraam Missed abortion. Misoprostol Mifepristone.
Conditions
Interventions
Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients receive oral mifepristone (600mg).
The control arm receives an
Sponsors
Canisius Wilhelmina Ziekenhuis Nijmegen
Eligibility
Inclusion criteria
Inclusion criteria: nclusion Criteria: Early pregnancy failure, 6-14 weeks postmenstrual with - a crown-rump length ≥ 6mm and no cardiac activity OR - a crown-rump length <6mm and no fetal growth at least one week later OR - a gestational sac with absent embryonic pole for at least one week. • At least one week after diagnosis OR a discrepancy of at least one week between crownrump length and calendar gestational age • Intrauterine 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 |
|---|---|
| Complete evacuation/ succesful treatment Whether or not complete evacuation (total endometrial thickness <15 mm) has been acquired will be assessed 15-20 days after the initial treatment. If so, this will be considered a complete evacuation and thus successful treatment. If the total endometrial thickness is ≥ 15 mm, ultrasonography will be repeated six weeks after initial treatment. Once again, if the total endometrial thickness is <15 mm this will be considered as a complete evacuation and thus a successful treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| patient satisfaction, complications, side effects and costs. | — |
Contacts
Public ContactC.C. Hamel
Canisius Wilhelmina Ziekenhuis / Radboud UMC
Outcome results
None listed