Comparing two medical treatments for early pregnancy failure.

Phase 1

• Conditions: Early pregnancy failure; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2017-002694-19-NL
• Lead Sponsor: Radboud University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-19
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 460

Inclusion 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 464
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient does not meet inclusion criteria, discovered after randomization.
Inability to give informed consent.
Interaction between study-medication and other medicine.
Contra-indications for the use of Mifepristone and/or Misoprostol.
Language barrier

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To identify whether Mifepristone in combination with Misoprostol is more effective in uterine evacuation after early pregnancy failure than Misoprostol alone. ;Secondary Objective: patient satisfaction, complications, side effects and costs;Primary end point(s): Complete evacuation of the uterus, which is determined as a total endometrial thickness of less then 15 mm. ;Timepoint(s) of evaluation of this end point: The first evaluation will take place 15- 20 days after initial treatment. If a complete evacuation hasn't occured at that time, a second evaluation will take place six weeks after the initial treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): patient satisfaction, complications, side-effects and costs.;Timepoint(s) of evaluation of this end point: two and six weeks after initial treatment.