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. 2018 Dec 19;2018(12):CD011689. doi: 10.1002/14651858.CD011689.pub3

Gerstenfeld 2001.

Methods 2‐arm placebo‐controlled randomised trial
Participants 400 women were randomised in a hospital setting in the USA. The population comprised women of unspecified parity, a singleton pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women with multiple pregnancy, coagulopathy, Hb less than 70 g/L, indication for caesarean section or contraindication to prostaglandin or oxytocin use.
Interventions 400 mcg of misoprostol administered rectally versus 20 IU of oxytocin administered by an IV infusion
Outcomes The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; diarrhoea; nausea; vomiting; shivering.
Notes Contact with study authors for additional information: Yes. Additional data from authors: No
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The randomisation was carried out by an uninvolved party and was determined by a random number sequence.
Allocation concealment (selection bias) Low risk The random number sequence was prepared by a third party and was concealed until the patient was enrolled. Packets were prepared in advance of randomisation.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The random number sequence was quote: "concealed until the patient was enrolled" and "packets were prepared in advance of randomisation".
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Assessors were blinded to treatment allocations.
Objective assessment of blood loss Low risk Investigators appraised blood loss (a) by collection with drapes placed under the mother. Each drape included a plastic pouch and measured volume in mL. Meanwhile the dry weights of delivery linen and sponges were subtracted from bloodied weights to determine the volume of blood collected with these materials, on the basis that 1 g is equivalent to 1 mL. The volumes of blood in drapes and linen were added together. Furthermore quote: "if amniotic fluid loss [after placement of the drape] was significant... the approximate percentage was recorded on the data sheet and blood loss was adjusted accordingly". Investigators appraised blood loss (b) by estimation of the delivery attendant(s). Investigators appraised blood loss (c) by measurement of Hb and haematocrit values were obtained on admission and on postpartum day 1. The differences between these 2 values were recorded.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "Of the 75 women who were excluded from analysis, 73 underwent cesarean deliveries, one woman was discharged to home before delivery, and one had an initial haemoglobin
 of 6.8 mg/dL".
Selective reporting (reporting bias) Unclear risk The protocol of the study was unavailable for verification.
Intention to treat analysis High risk Those who withdrew from the study after randomisation were not included in the analysis.
Funding source Unclear risk Source(s) of funding for the study were not reported.