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) |
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Interventions |
Intervention: active management of 3rd stage (N = 827)
Comparison: mixed management of 3rd stage (N = 821)
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 |
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Outcomes |
Primary: PPH Secondary: duration of 3rd stage, retained placenta, shock, blood transfusion, methylergonovine or 15‐methyl‐a‐prostaglandin to control haemorrhage |
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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 |
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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 |