Ramin 1994.
Study characteristics | ||
Methods | RCT | |
Participants | 32 women Inclusion criteria: healthy pregnant women undergoing elective caesarean at term (38 to 40 weeks' gestation) with spinal anaesthesia Exclusion criteria: women in labour, hypertension, diabetes, platelet counts < 100,000 mm3, prolonged thromboplastin time, fetal distress, cardiac or pulmonary disease, any medical illness, or a known history of drug abuse |
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Interventions |
Prophylactic angiotensin versus prophylactic ephedrine versus control Group 1: angiotensin II (1000 ng/mL in 0.9% sodium chloride) Group 2: ephedrine (1 mg/mL) Group 3: control (no prophylactic intervention) All women received a standardised crystalloid preload and a standardised spinal anaesthetic technique with slight variation in spinal anaesthetic doses. |
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Outcomes |
Maternal: hypotension (defined as decrease of > 30% from baseline); arterial BP (mean and SD);
angiotensin levels Neonatal: Apgar scores at 1 min and 5 min (mean and SD); pH < 7.2; umbilical artery pH (mean and SD); umbilical venous pH (mean and SD); pCO2; BE |
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Notes | Hypotension was defined as a decrease in BP of > 30% from baseline. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomised" but method otherwise not described |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding not stated |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses to follow‐up: 2/32 – 1 woman in the control group with a fetal death; 1 woman (group not specified) gave birth before her scheduled procedure |
Selective reporting (reporting bias) | Unclear risk | Unclear reporting |
Other bias | Unclear risk | Unclear reporting |