British journal of obstetrics and gynaecology · 1998
Intra-umbilical vein injection and retained placenta: evidence from a collaborative large randomised controlled trial. Grupo Argentino de Estudio de Placenta Retenida.
Клиническое исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Carroli G, Belizan J M, Grant A, Gonzalez L, Campodonico L, Bergel E
Аннотация
OBJECTIVE: To determine whether intra-umbilical vein injection with saline solution, with or without oxytocin, reduces the need for manual removal of placenta compared with expectant management.
DESIGN: Multicenter, randomised controlled trial.
SETTING: Eleven hospitals in four cities of Argentina: Buenos Aires, Corrientes, Rosario, and Salta.
PARTICIPANTS: Two hundred and ninety-one women showing no evidence of placental separation thirty minutes after vaginal delivery.
INTERVENTIONS: Three different management strategies: 1. intra-umbilical vein injection of saline solution plus oxytocin; 2. intra-umbilical vein injection of saline solution alone; and 3. expectant management.
MAIN OUTCOME MEASURES: Primary: manual removal of the placenta. Secondary: blood loss after trial entry, haemoglobin level at 24 to 48 hours and at 40 to 45 days after delivery, blood transfusion, curettage, infection, and days of hospital stay.
RESULTS: Rates of subsequent manual removal were similar: intra-umbilical vein injection of saline solution plus oxytocin (58%; RR 0.92; 95% CI 0.73-1.15), or saline alone (63%; RR 1.00; 95% CI 0.80-1.24), compared with expectant management (63%). There were also no detectable effects of the active managements on any of the secondary measures of outcome.
CONCLUSIONS: Based on evidence available from randomised controlled trials, including this trial, it is unlikely that intra-umbilical injection with or without oxytocin, is clinically useful. We recommend that this intervention should not be used in third stage management of labour.
DESIGN: Multicenter, randomised controlled trial.
SETTING: Eleven hospitals in four cities of Argentina: Buenos Aires, Corrientes, Rosario, and Salta.
PARTICIPANTS: Two hundred and ninety-one women showing no evidence of placental separation thirty minutes after vaginal delivery.
INTERVENTIONS: Three different management strategies: 1. intra-umbilical vein injection of saline solution plus oxytocin; 2. intra-umbilical vein injection of saline solution alone; and 3. expectant management.
MAIN OUTCOME MEASURES: Primary: manual removal of the placenta. Secondary: blood loss after trial entry, haemoglobin level at 24 to 48 hours and at 40 to 45 days after delivery, blood transfusion, curettage, infection, and days of hospital stay.
RESULTS: Rates of subsequent manual removal were similar: intra-umbilical vein injection of saline solution plus oxytocin (58%; RR 0.92; 95% CI 0.73-1.15), or saline alone (63%; RR 1.00; 95% CI 0.80-1.24), compared with expectant management (63%). There were also no detectable effects of the active managements on any of the secondary measures of outcome.
CONCLUSIONS: Based on evidence available from randomised controlled trials, including this trial, it is unlikely that intra-umbilical injection with or without oxytocin, is clinically useful. We recommend that this intervention should not be used in third stage management of labour.