Modi 2014.
Methods | Randomised controlled trial. Patients were randomised into 4 groups. |
|
Participants | Women presenting to the Shri Ram Murti Smarak Institute of Medical Sciences, Bareilly, Uttar Pradesh from 2012 to 2013. Women who were gravida < 4 with a singleton pregnancy between 37 and 42 weeks' gestation, cephalic, with no high risk factors presenting for induction or in spontaneous labour, were included. Women with the following were excluded: gestation < 37 weeks or > 42 weeks, fetal demise, fetal growth restriction, hypertension, abruption, placenta previa, multiple pregnancy, grand multipara, malpresentation, chorioamnionitis, known blood coagulation disorder, known allergy to prostaglandins, history of medical disorders including cardiac or renal disease, anaemia with Hb < 8, pulse rate > 100 bpm, blood pressure < 90/60 mm Hg. |
|
Interventions | Immediately after delivery women received: A. oxytocin 10 IU IM (n = 25) or B. methylergometrine 0.2 mg IV (n = 25) All received controlled cord traction to facilitate placental delivery. Following delivery, calibrated drapes were placed beneath the patient to measure blood loss. There were 2 additional intervention arms in this trial that were not relevant to this review. 1 group received 15‐methyl PGF2‐alpha 125 mcg IM, and the other received misoprostol 600 mcg PR. |
|
Outcomes | Outcomes: duration of the third stage of labour, measured blood loss in the third stage, decrease in mean Hb levels, post delivery heart rate and blood pressure, side effects of various uterotonics including nausea, vomiting, shivering, fever, hypertension, tachycardia. Other outcomes that were not pre‐specified: # of patients with blood loss > 500 mL, # of patients requiring blood transfusion, use of additional uterotonics. | |
Notes | Dates of study: 2012 ‐ 2013. Funding sources: none Declarations of interest: none |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation is unclear. Authors state “patients were randomised into four groups of 25 each” and “patients were distributed in four different groups randomly.” |
Allocation concealment (selection bias) | Unclear risk | Method of randomisation is unclear. Authors state “patients were randomised into four groups of 25 each” and “patients were distributed in four different groups randomly.” |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Authors do not explicitly state how many patients were ultimately included in the analysis. They do not mention patient attrition, however they state that women with perineal and cervical lacerations were excluded from the study. According to their demographics table, the majority of patients received an episiotomy, which would have resulted in exclusion of significant numbers of patients after randomisation. |
Selective reporting (reporting bias) | High risk | Some adverse outcomes of interest are reported incompletely. The authors report “side effects of various uterotonics” as outcomes, however data regarding vomiting, nausea, shivering, fever, headache and hypertension are incompletely reported for the oxytocin and methylergometrine groups. |
Other bias | Unclear risk | Unclear. |