Kundra 2007.
| Study characteristics | ||
| Methods | RCT | |
| Participants | 90 women Inclusion criteria: ASA physical status I or II, with full‐term singleton pregnancies and scheduled to undergo elective or emergency lower segment CS under subarachnoid block; without maternal or fetal complications Exclusion criteria: essential or pregnancy‐induced hypertension, diabetes, pre‐eclampsia, heart disease, placental abruption, prematurity (< 37 weeks' gestation), obesity, haemoglobin < 7g/dL, intrauterine growth restriction, fetal distress, fetal anomalies Setting: India |
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| Interventions |
Left lateral tilt versus left manual uterine displacement Group 1: left lateral tilt: women received 15 degree left lateral tilt immediately following administration of anaesthetic Group 2: left manual uterine displacement: women received manual displacement of the uterus immediately following anaesthetic; positioned supine without left lateral tilt All women received standardised aspiration prophylaxis, standardised crystalloid preload, standardised spinal anaesthetic technique and dose. Hypotension (requiring intervention) was treated with IV boluses of ephedrine (6 mg) until SBP was restored to > 90 mmHg. |
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| Outcomes |
Maternal: hypotension; ephedrine requirement Neonatal: Apgar at 1 min, 5 min, and 10 min |
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| Notes | Hypotension was defined as SBP < 90 mmHg or < 80% of baseline value Bradycardia defined as heart rate < 60 bpm |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
| Allocation concealment (selection bias) | Unclear risk | "Sealed envelope technique." |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "Manual displacement of the uterus was provided by a person other than the attending anaesthetist who was blinded to the haemodynamic parameters being displayed by screen separation." |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Apgar scores were assessed by a clinician who was blinded to group assignment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses reported |
| Selective reporting (reporting bias) | Unclear risk | Not all expected outcomes were reported or reported completely |
| Other bias | Low risk | Baseline characteristics were similar |