Miscarriage
Conditions
Interventions
The study will be carried out at Teaching Hospital Jaffna.
Participants meeting the inclusion/exclusion criteria will be allocated to the study arms using simple randomization.
Arm 1 (intervention a
Sponsors
Teaching Hospital Jaffna
Eligibility
Inclusion criteria
Inclusion criteria: 1. A diagnosis of pregnancy loss will be made when Mean gestational sac diameter exceeds 20 mm in the absence of a yolk sac or embryo and absence of fetal cardiac activity as determined by observing the area of the fetal heart for at least 30 seconds 2. Gestational age at 12 weeks or less 3. Haemodynamically stable. 4. Temperature not more than 37.5 degrees Celsius 5. No history or concurrent acute medical or surgical condition. 6. Legally married woman 7. Not taking anticoagulants or corticosteroids 8. Not on intrauterine device
Exclusion criteria
Exclusion criteria: 1. Suspected ectopic pregnancy (on clinical and ultrasound examination) 2. Pelvic infection 3. Diagnosed bleeding disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete miscarriage [At 12 hours post procedure in the manual vacuum aspiration arm; At Day 7 and 14 in the expectant care arm] | — |
Secondary
| Measure | Time frame |
|---|---|
| Unplanned surgical evacuatio [At 12 hours post procedure in the manual vacuum aspiration arm; At Day 14 in the expectant care arm] Patient satisfaction (assessed using a customized questionnaire) [At the end of the primary out come in each arm] Need for blood transfusion (haemoglobin level less than 8.0g/dl at the end of two weeks for expectant care and 12 hours after procedure for manual vacuum aspiration.) [At 12 hours post procedure in the manual vacuum aspiration arm; At Day 14 in the expectant care arm] Complications a) Pain and pain relief (Score on a 10 point Visual Analogue Scale scale, dose and frequency of analgesics) b) Pelvic infection (temperature > 98.6 degrees Celcius; elevated white cell count (>11,000mm3); c- reactive protein >5) c) Reduction in the Haemoglobin level d) Uterine or cervical damage (By laparoscopy and vaginal examination) [a) Pain and pain relief (Score on a 10 point Visual Analogue Scale scale, dose and frequency of analgesics) Up to 24 hours post procedure in the manual vacuum aspiration arm At Day 14 in the expectant care arm b) Pelvic infection At any readmission with symptoms in the manual vacuum aspiration arm (up to day 14 post procedure) Up to day 14 in the expectant care arm c) Reduction in the Haemoglobin level At baseline and prior to 12 hours post procedure in the manual vacuum aspiration arm At Day 7 or 14 in the expectant care arm d) Uterine or cervical damage: Up to 24 hours post procedure in the manual vacuum aspiration arm Not measured in the expectant care arm ] Duration of hospital stay [At time of discharge] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. R.Sutharshan
Registrar in Obstetrics and Gynaecology
Outcome results
None listed