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. 2019 Feb 13;2019(2):CD007412. doi: 10.1002/14651858.CD007412.pub5

Khan 1997.

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 CS in second stage (9 excluded, final sample 1648)
Interventions Intervention: active management of 3rd stage (N = 827)
  • prophylactic oxytocin 10 units IM at birth of anterior shoulder (or if breech, soon after delivery of baby)

  • cord clamped and cut immediately

  • CCT as soon as the uterus was contracted firmly. Repeated every 2‐3 min.


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

  • cord clamped and cut after delivery

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

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


In both groups, if placenta not delivered after 30 min, CCT or digital removal attempted, with IV oxytocin infusion if bleeding present
Data included in comparison 10
Outcomes Primary: PPH
Secondary: duration of 3rd stage, retained placenta, shock, blood transfusion, methylergonovine 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 USA but not elsewhere
Dates of study: January‐June 1995
Funding sources: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No detail
Allocation concealment (selection bias) Unclear risk Numbered, sealed, opaque envelopes. However, if sequence generation is not random then allocation cannot be concealed
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Attempted with 2nd MW recording blood loss – however, no guarantee that the 1st MW could/would not have altered the amount of blood in the receptacle, so not any better than just 1 clinician measuring
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information provided
Presumed blinded, but unclear
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 All outcomes listed in the methods are reported, but there is no protocol for the study available
Other bias High risk 2582 out of 4239 refused to participate. Those that did agree may have been biased.
It is unknown whether or not the midwives had sufficient training in physiological 3rd stage before the study started.
This study 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 of low‐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