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. Author manuscript; available in PMC: 2014 May 19.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Nov 9;(11):CD007412. doi: 10.1002/14651858.CD007412.pub3
Methods Randomised controlled trial of individual women in low-income setting
Participants Setting: Sousse, Tunisia. Low-income country.
Women with singleton pregnancies expecting to give birth vaginally
Exclusion criteria: placenta praevia, APH, non-cephalic presentation, intrauterine death, parity > 5, uterine fibroids, anticoagulation therapy, history of PPH, history of CS
Interventions Intervention: active management of 3rd stage (N = 65):

  1. IV flash injection of 5 IU oxytocin at time of delivery of anterior shoulder;

  2. immediate cord clamping and cutting;

  3. CCT with gentle fundal pressure when signs of separation appeared;

  4. manual removal if not delivered by 30 minutes or if haemorrhaging.

Comparison: mixed management of 3rd stage (N = 65):

  1. no routine uterotonic (not stated in publication, but author provided information on 19th March 2011);

  2. immediate cord clamping and cutting;

  3. CCT plus gentle fundal pressure when signs of separation appeared;

  4. manual removal if not delivered by 30 minutes or if haemorrhaging.


Data included in Comparison 12
Outcomes Pre-specified: reduction in HCT and Hb.
Notes We contacted the authors again on 14th March 2011, for further information on the management in the comparison arm, the methodology they used and data obtained. Reply received 19th March 2011. No publication has emanated, no further data were provided, but methodology was clarified
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk As per www.randomization.com (not stated in publication but information provided by author on 19 March 2011)
Allocation concealment (selection bias) High risk Not concealed in any way (not stated in publication, but in information provided by author on 19 March 2011)
Incomplete outcome data (attrition bias) All outcomes Low risk No loss described in publication and confirmed by information from author on 19 March 2011. Authors also provided information that the analysis was by ‘intention to treat’
Selective reporting (reporting bias) Unclear risk We did not assess the trial protocol.
Other bias Unclear risk Women reported to have been allocated to groups after placental delivery yet active management group supposedly had oxy-tocin with the anterior shoulder