Skip to main content
. Author manuscript; available in PMC: 2014 Jun 3.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007223. doi: 10.1002/14651858.CD007223.pub2
Methods RCT with randomisation of individual women.
Participants Inclusion criteria
  • Women with uncomplicated incomplete spontaneous miscarriage assessed with ultrasound.

  • Women with a history of vaginal bleeding, cramping abdominal pain and passage of some products of the conceptus; in good health with a normal hemoglobin level (> 9 g/dl) and haemodynamically stable; estimated gestational age was ≤ 10 weeks, if the anterior-posterior diameter of any retained product of the conceptus was < 50 mm, and if they had no contraindication to prostaglandin treatment.

  • N = 80 women.

Exclusion criteria
  • Women with temperature > 37.5 °C, excessive vaginal bleeding requiring immediate surgical evacuation, haemodynamic instability or foul-smelling products of the conceptus.

Interventions Intervention: vaginal misoprostol.
  • 200 ug 4 times daily after application of 200 ug intravaginal misoprostol for 5 days.

  • N = 40.

Comparison: surgical management.
  • Curettage, sometimes with general anaesthesia.

  • N = 40.

Outcomes Number of days of vaginal bleeding; rate of complications (fall in Hb, infection, perforation) and women’s satisfaction
  • Miscarriage assessed at 10 days but no indication on whether this was a clinical assessment or by ultrasound.

Notes
  1. Setting: University hospital, Turkey.

  2. Additional outcomes assessed but not pre-specified in the review: mean change in Hb; dissatisfaction.

Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided except to say women were randomised.
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding (performance bias and detection bias)
All outcomes
High risk Participants nor clinicians cannot be blinded. There is nomention as to whether the outcome assessor was blinded. For outcomes where participants assessed for themselves, these were not blinded
Incomplete outcome data (attrition bias)
All outcomes
Low risk No losses and no exclusions were reported, but nothing is described. As there is no deviation from protocol it is assumed that analysis was by ITT
Selective reporting (reporting bias) Unclear risk Seem to report on all outcomes specified in ‘Materials and methods’ but we did not assess the trial protocol
Other bias Unclear risk No imbalances in baseline data identified (assessed: age, gravity, parity, gestational age, anterior-posterior diameter). Study not stopped early and no apparent differential diagnosis