Safety and effectiveness of vacuum aspiration, compared to curettage for management of patients with first trimester miscarriage in a limited resource setting in Sri Lanka.
Phase 2
Recruiting
- Conditions
- Miscarriage
- Registration Number
- SLCTR/2017/023
- Lead Sponsor
- De Zoysa Hospital for Women
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
1. Diagnosis of miscarriage of less than 13 weeks POA (period of amenorrhea)
2. No documented febrile illness
3. Haemodynamically stable patients without any acute medical or surgical problems
Exclusion Criteria
1. Patients with features suggestive of septic miscarriage
2. Patients who have the history of bleeding disorders/ anticoagulant therapy
3. Patients found to have molar pregnancies
4. Patients who are not willing to participate in the study
5. Patients with suspected ectopic pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimated blood loss and need for blood transfusion - using visual estimation of the number of soaked towels or sanitary pads and amount of blood clots in kidney tray, and haemoglobin concentration 24 hours post-procedure.<br> [Immediately post procedure, and at the end of 24 hours.<br>]<br>Need for repeated evacuation (endometrial thickening more than 10mm on ultra sound scan of the abdomen at 12 hours post-procedure) [12 hours post procedure]<br>Post-operative pain using a visual pain analogue scale. [6 hours post procedure]<br>Cervical trauma (on visualization of the cervix post-procedure) [Immediately post procedure<br>]<br>Duration of procedure (in minutes) [ At the end of the procedure.]<br> Duration of hospital stay [At discharge]<br>
- Secondary Outcome Measures
Name Time Method one [None]<br>