Thilaganathan 1993.

Methods	RCT with randomisation of individual women
Participants	UK hospital setting. High‐income country Inclusion criteria: women at "low risk of PPH” (defined only by the exclusion criteria for study) and at term (37‐42 weeks). 193 women randomised, from an unknown population Exclusion criteria: grand multiparity; malpresentation, multiple pregnancy; previous CS or PPH; APH; pregnancy‐induced hypertension and IUFD Then after randomisation: women who had had augmentation, instrumental or OVB, 3rd degree tear and cervical laceration
Interventions	Intervention: active management of 3rd stage (N = 103): 1 mL syntometrine (not stated whether IM or IV) as soon as baby born cord “was immediately clamped” placenta delivered by CCT Comparison: expectant management of 3rd stage (N = 90): presumed no oxytocic, though not stated in the published paper Authors’ information by letter states: “No oxytocics or placebos were given to the physiological group” cord not cut or clamped until after pulsation ceased (unless there were contraindications, e.g. cord round neck, after clamping, maternal end clamp removed as soon as possible to allow drainage) once there were signs of placental separation mother was encouraged to adopt an upright position and bear down, “when the placenta could be felt in the vagina, the midwife could then assist delivery of the placenta” Both groups: if placenta not delivered in 30 min, bladder emptied and medical assistance sought. If delivery not imminent manual removal performed. Medical assistance sought for any excessive blood loss Data included in comparisons 1 and 2
Outcomes	Pre‐specified outcomes: estimated blood loss; Hb in labour and 3rd postnatal day; length of 3rd stage; complications Reported outcomes: as above plus therapeutic uterotonics, blood transfusion
Notes	Drop in Hb is not calculated correctly. Maternal mean postnatal Hb reported as median and range. Active: 11.7 g/dL (10.7‐12.6 g/dL) and expectant 11.7 g/dL (10.9‐12.6 g/dL) Worrying problems with methodology and analysis Dates of study: January 1988‐February 1990 Funding sources: not reported Declarations of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “...randomly allocated using standard randomisation tables...”
Allocation concealment (selection bias)	Unclear risk	Not described. Not clear when randomisation occurred Quote: “...the midwife responsible for the management of her patient was not aware of the proposed allocation until her patient was entered into the study” (authors' information states: "randomised in the late 1st stage of labour when it was apparent that they were likely to delivery normally")
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible to blind participants and personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unknown
Incomplete outcome data (attrition bias) All outcomes	High risk	It is not clear how many were randomised. P. 20 states “A total of 193 women completed the study AND had all results available for complete analysis”. This could mean that a larger number were included but that some of their results were missing, and they were therefore excluded. This could lead to significant bias. It is very unlikely that all participants received the allocated management, yet this is not presented. The study groups were also very different sizes (103 and 93), which sounds unlikely. Women withdrawn after randomisation for operative delivery, third‐degree tears and cervical lacerations. Numbers were not given; there is a significant risk of bias here. It is not stated in the published paper whether or not ITT analysis was used, but the response to Diana Elbourne’s letter of April 1991 states that they did not analyse on "intention to treat" as it would not answer the aims of this preliminary study.
Selective reporting (reporting bias)	Unclear risk	All outcomes listed in the methods are reported, but there is no protocol available for the study
Other bias	High risk	Variables age, birthweight and parity said to be equal between the groups but no details given. No power calculation done. Not a null hypothesis The study groups were very different sizes (103 and 90)