None listed
Conditions
Interventions
Intervention1: Abortion through using Manual Vacuum Aspiration (MVA): Use of MVA syringe
Control Intervention1: NIL: NIL
Sponsors
The David and Lucile Packard Foundation California USA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Intra uterine pregnancy of 2. Hb >= 9gm/dl 3. No medical or gynaecological contraindications, including, suspicion of perforation from a previous interference, pregnancy with fibroid uterus, severe cervical stenosis, bleeding disorder, hyper tension, heart disease, renal disease, diabetes mellitus or signs of any other severe ill health (as per MoHFW Guidelines); 4. 18 years or older; 5. No clinical indication of ectopic pregnancy 6. Does not opt for concurrent tubal ligation 7. Living or working near a study site; 8. Willing to return on day 7 or 10 for follow up check up; 9. Willing to provide consent for participation in the study
Exclusion criteria
Exclusion criteria: 1. Uterine size > 10 weeks 2. Septic shock 3. Severe tenderness in lower abdomen and distension 4. Suspicion of perforation (from a previous interference) 5. Suspicion of ectopic pregnancy 6. Pregnancy with fibroid uterus 7. History of caesarean section or uterine surgery 8. Severe cervical stenosis 9. Medical disorder such as: ❖ Anaemia with haemoglobin below 8 gms. ❖ Bleeding disorders ❖ Hypertension ❖ Heart Disease ❖ Renal Disease ❖ Diabetes Mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (a) Failure of the procedure and complications: the proportion of all cases that were accepted into the study but who were assessed to have an incomplete abortion at the end of the procedure by the supervisor; (b) Complication rate: the proportion of all women who were accepted into the study and experienced complications either immediate or delayed and needed intervention by the supervisor Timepoint: Not Applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| (a) Failure to assess GA and abortion status (Assessment failure): the proportion of all clients who underwent two pelvic examinations for whom the study provider?s assessment did not match that of the supervisor and those for whom the final assessment of abortion status did not match at the end of the abortion procedure. (b) the acceptability of medical abortion and provider as assessed by clients in the course of the exit interview; and (c) provider satisfaction and experience. Timepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactSHIREEN JEJEEBHOY
Outcome results
None listed