A study to compare various treatment methods for the miscarriage during the first fourteen weeks of pregnancy

Not Applicable

Conditions: First trimester miscarriage

Registration Number: SLCTR/2014/029

Lead Sponsor: De Soysa Hospital for Women

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

1. Gestational age less than 14 weeks POA
2. Bleeding not excessive (Excessive bleeding: soaking through one or more pads every hour for several consecutive hours)
3. Haemodynamically stable
4. Temperature not more than 37.5 degrees Celsius
5. No history of current serious systemic medical or surgical condition
6. Use of prostaglandins not contraindicated (including no known allergies)
7. 18 years or older
8. Not taking anticoagulants or corticosteroids
9. Singleton pregnancy
10. No intrauterine device in situ.
11. Sufficient familiarity with Sinhala or Tamil to complete written questionnaires

Exclusion Criteria

1. Complete miscarriage
2. Sepsis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of complete miscarriage (defined as an empty uterus or homogenous intra uterine dimension measuring less than 11 cm2 [sagittal plus trans-vaginal plane] on trans-vaginal ultrasound examination). [At day 14 of following the intervention]<br>

Secondary Outcome Measures

Name	Time	Method
1. Unplanned surgical intervention [a second evacuation in the surgical group but a first evacuation in the medical or expectant group] <br>2. Blood transfusion <br>3. Hemorrhage [blood loss greater than 500ml] <br>4. Anaemia [reduction of equal or more than 2g/dl from the Hb level on admission] <br>5. Days of bleeding <br>6. Pain relief [Type, dose and duration of NSAIDs] <br>7. Pelvic infection <br>8. Cervical damage/Uterine perforation <br>9. Digestive disorders [nausea/vomiting/ diarrhoea] <br>10. Duration of stay in hospital <br>11. Psychological effects [assessed by GHQ-12] <br>12. Women’s views/ acceptability of method<br><br><br><br><br><br><br><br> [At Day 7, Day 14, and Day 28 following the intervention]<br>