GEM study for ectopic pregnancy
- Conditions
- Ectopic pregnancy or pregnancy of unknown location.MedDRA version: 14.0 Level: PT Classification code 10014166 Term: Ectopic pregnancy System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2011-001747-69-GB
- Lead Sponsor
- Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
1. Women aged between 18 and 45 inclusive
2. Women with serum hCG greater than 5
3. Women with either a mass which on ultrasound has the appearance of an ectopic pregnancy or a pregnancy of unknown location
4. No clinical evidence of intra-uterine bleeding
5. No pallor
6. No guarding/rigidity on abdominal examination
7. Stable blood pressure and heart rate
8. Normal haemaglobin on full blood examination at day 1.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1. History of significant pulmonary disease (eg lung carcinoma including mesothelioma, chronic obstructive airways disease, emphysema, pneumonitis, silicosis, pulmonary fibrosis, severe/brittle asthma, ILD)
2. Abnormal liver indices
3. Abnormal renal indices
4. Abnormal haematological indices
5. Significant pre-existing dermatological condition (eg psoriasis, excema)
5. Significant pre-existing gastrointestinal illness (eg inflammatory bowel disease, bowel carcinoma)
6. Japanese ethnicity.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method