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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 RCT with randomisation of individual women.
Participants Abu Dhabi hospital setting. High-income country.
Inclusion criteria: all women expected to give birth vaginally. 1657 women randomised out of a possible 4239
Exclusion criteria: refusal or caesarian section in second stage (9 excluded, final sample 1648)
Interventions Intervention: active management of 3rd stage (N = 827):
  1. prophylactic oxytocin 10 units IM at birth of anterior shoulder (OR if breech, soon after delivery of baby);

  2. cord clamped and cut immediately;

  3. CCT as soon as the uterus was contracted firmly. Repeated every 2-3 minutes.

Comparison: mixed management of 3rd stage (N = 821):
  1. no IM/IV oxytocic;

  2. cord clamped and cut after delivery;

  3. no cord traction. No fundal massage or pressure. Signs of separation awaited, then maternal expulsion of placenta;

  4. IV infusion of oxytocin 10 units in 500 mL normal saline given slowly after delivery.

In both groups, if placenta not delivered after 30 minutes, CCT or digital removal attempted, with IV oxytocin infusion if bleeding present
Data included in Comparison 10.
Outcomes Primary: PPH.
Secondary: duration of third stage, retained placenta, shock, blood transfusion, methy-lergonovine or 15-methyl-a-prostaglandin to control haemorrhage
Notes Not readily comparable to other studies as IV oxytocin infusion given to all women in expectant management group after delivery of placenta. This is the practice in the US but not elsewhere
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No detail.
Allocation concealment (selection bias) Low risk Numbered sealed opaque envelopes.
Incomplete outcome data (attrition bias) All outcomes Unclear risk 2582 excluded prior to randomisation due to refusal. 9 excluded after randomisation due to emergency CS.
Selective reporting (reporting bias) Unclear risk No trial protocol reviewed. Most reported outcomes were pre-specified. Mean change in haematocrit was reported, but not pre-specified
Other bias Unclear risk 2582 out of 4239 refused to participate. Those that did agree may have been biased It is unknown whether or not the mid-wives had sufficient training in physiological third stage before the trial started This trial has been criticised for including all women (including high parity, all age groups, previous PPH, epidural, long labour, operative delivery) and not confining inclusion criteria to women who were low risk. Women at high risk of PPH will have a higher blood loss using expectant management; clinicians experiencing this may respond by anxiety in subsequent births, even oflow-risk women, which may result in higher intervention (mixed management) rates Also, the minimal intervention (control) group had the cord clamped and cut immediately after delivery, which is suspected to lead to an increase in blood loss