Comparing Two Medical Treatments for Early Pregnancy Failure.
- Registration Number
- NCT03212352
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
This study aims to compare whether a combination of two drugs (Mifepristone and misoprostol) are superior compared to using only one of these drugs (Misoprostol) as medical treatment for a miscarriage. Women in whom early pregnancy failure, 6-14 weeks postmenstrual, is ultrasonographically confirmed qualify for this study.
It is expected that the combination of Mifepristone and Misoprostol is more effective in reaching complete evacuation, and therefore can prevent more invasive treatment such as curettage.
- Detailed Description
This study will test the hypothesis that, in early pregnancy failure, the sequential combination of mifepristone with misoprostol is superior to the use of misoprostol alone in terms of complete evacuation of products of conception (primary outcome), patient satisfaction, complications, side effects and costs (secondary outcomes). The trial will be performed multi-centred (hospitals), prospectively, two-armed, randomized, double-blinded and placebo-controlled.
Women with ultrasonographically confirmed early pregnancy failure (6-14 weeks postmenstrual), managed expectantly for at least one week, can be included. Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients will be randomized to oral mifepristone (600mg) or oral placebo (identical in appearance). The investigators aim to randomize 460 women in a 1:1 ratio, stratified by centre.
After six weeks, the primary endpoint, complete or incomplete evacuation, will be determined
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 342
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 crown-rump length and calendar gestational age
- Intra-uterine pregnancy
- Women aged above 16 years
- Hemodynamic stable patient
- No signs of infection
- No signs of incomplete abortion
- No contraindications for mifepristone or misoprostol
- Patient does not meet inclusion criteria, discovered after randomization
- Inability to give informed consent
- Known clotting disorder or use of anticoagulants
- Known risk factors for, or presence of, a cardiovascular disease
- Language barrier
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Misoprostol and Mifepristone Mifepristone 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). Misoprostol Misoprostol Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients receive an oral placebo. Misoprostol and Mifepristone Misoprostol 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).
- Primary Outcome Measures
Name Time Method Complete evacuation six weeks after initial treatment Whether or not complete evacuation (total endometrial thickness \<15 mm) has been acquired will be assessed through ultrasonography.
- Secondary Outcome Measures
Name Time Method Overall quality of health, as experienced by the patient. At baseline, day four, and two and six weeks after initial treatment. To measure the quality of the health status of the patients,a validated so-called health-related quality of life (HRQoL) instrument will be used: the EuroQol-5D.
patient satisfaction At baseline, day four, two and six weeks after treatment To assess how satisfied patient are with the treatment they underwent. Patient satisfaction with treatment will be measured using The Client Satisfaction Questionnaire (CSQ-8, digital)
costs up to six weeks after treatment To evaluate which medical treatment strategy is cost-effective, volumes of health care consumed will additionally be measured prospectively alongside the clinical trial together with cost associated with productivity losses. Costs of medical interventions (direct costs) and costs resulting from productivity loss (indirect costs) will be taken into account. Resource uses will be recorded in the case report forms. Standardized unit costs will be calculated using the Dutch manual for costing in economic evaluations and standardised costs.
side effects six weeks after treatment Which side effects have patients experienced and to what degree?
complications six weeks after treatment How many and which complications have occured?
Trial Locations
- Locations (13)
Amphia Hospital
🇳🇱Breda, Netherlands
Rijnstate
🇳🇱Arnhem, Gelderland, Netherlands
Radboud University Medical Centre
🇳🇱Nijmegen, Gelderland, Netherlands
Maasstad Ziekenhuis
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Canisius Wilhelmina Hospital
🇳🇱Nijmegen, Gelderland, Netherlands
OLVG
🇳🇱Amsterdam, Netherlands
Catharina Hospital
🇳🇱Eindhoven, Netherlands
Martini Hospital
🇳🇱Groningen, Netherlands
Zuyderland Medical Centre
🇳🇱Heerlen, Netherlands
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Laurentius Hosptial
🇳🇱Roermond, Netherlands
VieCuri Medical Centre
🇳🇱Venlo, Netherlands
Haaglanden Medical Centre
🇳🇱The Hague, Netherlands