OBJECTIVE: Higher-dose oxytocin is more effective than lower-dose regimens to prevent postpartum hemorrhage after cesarean delivery. We compared two higher-dose regimens (80 units and 40 units) to our routine regimen (10 units) among women who delivered vaginally. METHODS: In a double-masked randomized trial, oxytocin (80 units, 40 units, or 10 units) was administered in 500 mL over 1 hour after placental delivery. The primary outcome was a composite of any treatment of uterine atony or hemorrhage. Prespecified secondary outcomes included outcomes in the primary composite and a decline of 6% or more in hematocrit. A sample size of 600 per group (N=1,800) was planned to compare each of the 80-unit and 40-unit groups to the 10-unit group. At planned interim review (n=1,201), enrollment in the 40-unit group was stopped for futility and enrollment continued in the other groups. RESULTS: Of 2,869 women, 1,798 were randomized as follows: 658 to 80 units; 481 to 40 units; and 659 to 10 units. Most characteristics were similar across groups. The risk of the primary outcome in the 80-unit group (6%; relative risk [RR] 0.93, 95% confidence interval [CI] 0.62-1.40) or the 40-unit group (6%; RR 0.94, 95% CI 0.61-1.47) was not different compared with the 10-unit group (7%). Treatment with additional oxytocin after the first hour was less frequent with 80 units compared with 10 units (RR 0.41, 95% CI 0.19-0.88), as was a 6% or more decline in hematocrit (RR 0.83, 95% CI 0.69-0.99); both outcomes declined with increasing oxytocin dose. Outcomes were similar between the 40-unit and 10-unit groups. CONCLUSION: Compared with 10 units, 80 units or 40 units of prophylactic oxytocin did not reduce overall postpartum hemorrhage treatment when administered in 500 mL over 1 hour for vaginal delivery. Eighty units decreased the need for additional oxytocin and the risk of a decline in hematocrit of 6% or more. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00790062. LEVEL OF EVIDENCE: I.
RCT Entities:
OBJECTIVE: Higher-dose oxytocin is more effective than lower-dose regimens to prevent postpartum hemorrhage after cesarean delivery. We compared two higher-dose regimens (80 units and 40 units) to our routine regimen (10 units) among women who delivered vaginally. METHODS: In a double-masked randomized trial, oxytocin (80 units, 40 units, or 10 units) was administered in 500 mL over 1 hour after placental delivery. The primary outcome was a composite of any treatment of uterine atony or hemorrhage. Prespecified secondary outcomes included outcomes in the primary composite and a decline of 6% or more in hematocrit. A sample size of 600 per group (N=1,800) was planned to compare each of the 80-unit and 40-unit groups to the 10-unit group. At planned interim review (n=1,201), enrollment in the 40-unit group was stopped for futility and enrollment continued in the other groups. RESULTS: Of 2,869 women, 1,798 were randomized as follows: 658 to 80 units; 481 to 40 units; and 659 to 10 units. Most characteristics were similar across groups. The risk of the primary outcome in the 80-unit group (6%; relative risk [RR] 0.93, 95% confidence interval [CI] 0.62-1.40) or the 40-unit group (6%; RR 0.94, 95% CI 0.61-1.47) was not different compared with the 10-unit group (7%). Treatment with additional oxytocin after the first hour was less frequent with 80 units compared with 10 units (RR 0.41, 95% CI 0.19-0.88), as was a 6% or more decline in hematocrit (RR 0.83, 95% CI 0.69-0.99); both outcomes declined with increasing oxytocin dose. Outcomes were similar between the 40-unit and 10-unit groups. CONCLUSION: Compared with 10 units, 80 units or 40 units of prophylactic oxytocin did not reduce overall postpartum hemorrhage treatment when administered in 500 mL over 1 hour for vaginal delivery. Eighty units decreased the need for additional oxytocin and the risk of a decline in hematocrit of 6% or more. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00790062. LEVEL OF EVIDENCE: I.
Authors: Kemal Güngördük; Osman Asicioglu; Ozgu Celikkol; Yusuf Olgac; Cemal Ark Journal: Aust N Z J Obstet Gynaecol Date: 2010-02 Impact factor: 2.100
Authors: A M Gülmezoglu; J Villar; N T Ngoc; G Piaggio; G Carroli; L Adetoro; H Abdel-Aleem; L Cheng; G Hofmeyr; P Lumbiganon; C Unger; W Prendiville; A Pinol; D Elbourne; H El-Refaey; K Schulz Journal: Lancet Date: 2001-09-01 Impact factor: 79.321
Authors: Luisa A Wetta; Jeff M Szychowski; Samantha Seals; Melissa S Mancuso; Joseph R Biggio; Alan T N Tita Journal: Am J Obstet Gynecol Date: 2013-03-15 Impact factor: 8.661
Authors: Jennifer A Salati; Sebastian J Leathersich; Myfanwy J Williams; Anna Cuthbert; Jorge E Tolosa Journal: Cochrane Database Syst Rev Date: 2019-04-29
Authors: Rita de Cássia Teixeira Rangel; Maria de Lourdes de Souza; Cheila Maria Lins Bentes; Anna Carolina Raduenz Huf de Souza; Maria Neto da Cruz Leitão; Fiona Ann Lynn Journal: Rev Lat Am Enfermagem Date: 2019-08-19
Authors: Ioannis D Gallos; Helen M Williams; Malcolm J Price; Abi Merriel; Harold Gee; David Lissauer; Vidhya Moorthy; Aurelio Tobias; Jonathan J Deeks; Mariana Widmer; Özge Tunçalp; Ahmet Metin Gülmezoglu; G Justus Hofmeyr; Arri Coomarasamy Journal: Cochrane Database Syst Rev Date: 2018-04-25