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

Surgical, medical or expectant management of first trimester miscarriage and its implications on clinical and psychological outcomes - a Randomized Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2014/029

Enrollment

180

Registered

2014-10-23

Start date

2014-11-05

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First trimester miscarriage

Interventions

Consenting participants will be randomized into three arms using computer generated random numbers. Arm 1 (Surgical Management): Surgical management will be by vacuum aspiration under general anest

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Complete miscarriage 2. Sepsis.

Design outcomes

Primary

Measure	Time frame
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]	—

Secondary

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

Measure

Time frame

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

—

Countries

Sri Lanka

Contacts

Public ContactDr. M. Kopalakrishnan

Registrar, Professorial Unit

kopalakrishnan14@yahoo.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026