The comparison of two drug treatments for miscarriage

Phase 1

Conditions: Women aged above 18 years with early pregnancy failure, 6-14 weeks postmenstrual.
MedDRA version: 19.0Level: LLTClassification code 10068522Term: Non-surgical treatmentSystem Organ Class: 100000004865
MedDRA version: 19.0Level: LLTClassification code 10027650Term: Miscarriage of pregnancySystem Organ Class: 100000004868
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2013-001554-10-NL

Lead Sponsor: Radboudumc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

•Early pregnancy failure, 6-14 weeks postmenstrual with a
oCrown-rump length = 6mm and no cardiac activity OR
oGestational 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
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 60
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Th??is study will compare sequential mifepristone and misoprostol (M&M”) treatment versus misoprostol treatment alone, which is currently the standard medical treatment in the Netherlands.;Secondary Objective: The secondary objectives are patient satisfaction, side effects and complications.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: One week after treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary objectives are patient satisfaction, side effects and complications.;Timepoint(s) of evaluation of this end point: Six weeks after treatment.