De Groot 1996.

Methods	Randomised controlled trial. Hospital pharmacy supplied numbered boxes of tablets and ampoules according to computer‐generated randomisation list. Informed consent asked in early labour. Assigned before delivery of baby's head. Double‐blind for oral ergometrine vs placebo and unblinded for ergometrine and/or placebo vs oxytocin. Randomisation 1:2:2, oxytocin to ergometrine to placebo. Multicentre.
Participants	2 university hospitals, a midwifery school and independent midwives attending home births in and around Nijmegen, the Netherlands. Women expecting to deliver in one of these settings, and who did not develop following exclusion criteria: refusal, cardiovascular disease/hypertension, multiple pregnancy, non‐cephalic presentation, polyhydramnios, tocolysis 2 hours prior to delivery, anticoagulant therapy, stillbirth, APH, chemical induction or augmentation (oxytocin, prostaglandins), instrumental/operative delivery (some of these must have been post‐randomisation exclusions), anaemia Hb < 6.8 mmol/L (timing not stated), previous third stage complications. 4 of 371 women were assigned to the study erroneously (3 forceps, 1 augmentation) and were excluded post‐randomisation. Otherwise eligible women wishing a natural childbirth refused to enter the trial (numbers not stated).
Interventions	All 3 interventions given immediately after birth of baby: (1) IM 5 IU oxytocin (n = 78); (2) oral 0.4 mg ergometrine (n = 146); (3) oral placebo (143). Other third stage management expectant (although no information given about timing of cord clamping/cutting). When mother feels contractions or there are signs of separation, maternal effort encouraged, adopting position to aid gravity. If necessary, flat hand on abdomen to act as brace to aid pushing. Re‐attempt if placenta does not deliver spontaneously. If haemorrhage, administer extra oxytocics and/or controlled cord traction. Blood loss measured gravimetrically‐‐fresh perineal pad under perineum to absorb blood or fluid; gauzes and pads collected until 1 hour after delivery of placenta and weighed. 100 g increase in weight considered equivalent to 100 mL blood. Comparison for review is group 1 vs group 2 and group 1 vs group 3.
Outcomes	Mean blood loss (mL); PPH (> = 500 mL); severe PPH (> = 1000 mL); length of third stage (11 (range 4‐90), 15 (2‐90), 14 (3‐55) in oxytocin, ergometrine and placebo groups respectively. No information about whether mean or median, and SD not given); blood pressure 15, 30, 45 and 60 minutes after delivery of placenta, in institutional deliveries only (oral ergometrine showed no significant elevation); use of further oxytocics; MRP; transfusion.
Notes	Dates of study: July 1993 – July 1994 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	Numbered boxes of tablets and ampoules according to computer‐generated randomisation list.
Allocation concealment (selection bias)	Low risk	No difference could be detected between boxes.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Drugs administered via different routes so blinding not possible.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not mentioned in report
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition minimal and where outcome data missing, adequate explanation given.
Selective reporting (reporting bias)	Unclear risk	Protocol unseen
Other bias	Unclear risk	Unclear.