United Kingdom 2001c.
Methods | Open‐label, assessor‐blind, randomised controlled trial. | |
Participants | Pregnant women over 16 years of age and delivering infants after 24 completed weeks of gestation at the Northwick Park Hospital, a district general hospital in the UK. Exclusion criteria included a known sensitivity to either prostaglandins, ergotrates or oxytocin, had a history of asthma, glaucoma, raised intraocular pressure or were known to have cardiac, pulmonary, renal or hepatic disease, hypertension, sepsis or obliterative vascular disorders. Women were excluded if they were currently taking anticoagulant treatment or participating in other clinical trials. |
|
Interventions | 1 mL IM (250 mcg) of carboprost versus 1 mL of syntometrine (0.5 mg of ergometrine plus 5 units of syntocinon) intramuscularly at the time of presentation of the anterior shoulder. | |
Outcomes | Main outcome measure was the occurrence of primary postpartum haemorrhage (500‐1000 mL). Other measures include maternal haemoglobin and haematocrit measured 3 days later, mode and timing of delivery of the placenta and maternal blood pressure after delivery of the placenta and 1 hour later. side‐effects (diarrhoea, nausea, vomiting) were also measured. | |
Notes | Active management of third stage of labour. Blood loss was measured as accurately as possible, taking into consideration the liquor amnii and soiling of the surgical drapes. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not clear on how the random sequence was generated. |
Allocation concealment (selection bias) | Low risk | "The randomization slips were contained in envelopes which were opened by a person not involved in the postpartum assessments who resealed the envelope and drew 1 ml of the appropriate medication into a syringe." |
Blinding (performance bias and detection bias) All outcomes | Low risk | The study is open‐labelled, however, the outcome assessments are blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 woman in the carboprost group was excluded from the analysis because she did not receive the medication. |
Selective reporting (reporting bias) | Low risk | Primary outcomes of the review have been reported. |
Other bias | High risk | This study has been suspended during the interim analysis due to higher percentage of GI adverse events, especially diarrhoea seen in the Carboprost group. The groups were comparable at the baseline. |