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):
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 |