The journal of obstetrics and gynaecology research · 2018
Premaquick© versus modified Bishop score for preinduction cervical assessment at term: A double-blind randomized trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Eleje George U, Ezugwu Euzebus C, Ugwu Emmanuel O, Ezebialu Ifeanyichukwu U, Eleje Lydia I, Ojiegbe Nnabuike O, Ajah Leonard O, Obiora Chukwudi C, Egeonu Richard O, Okafor Chigozie G, Enyinna Perpetua K, Egede John O, Ugochukwu Nzubechukwu J, Asiegbu Amarachukwu C, Ikechebelu Joseph I
Аннотация
AIM: To test whether Premaquick biomarkers were superior to modified Bishop score for preinduction cervical assessment at term.
METHODS: A multicenter, double-blind randomized clinical trial in 151 nulliparous, cephalic presenting and singleton pregnancies was conducted. The cervix was considered 'ripe' when at least two out of three Premaquick biomarkers are positive or a Bishop score of ≥6. Main outcome measures were proportion of women who were administered or had additional prostaglandin E1 analogue (PGE1) as a preinduction agent and incidence of uterine rupture. The trial was registered in PACTR registry with approval number PACTR201604001592143. Analysis was performed by intention-to-treat principle.
RESULTS: The need for initial PGE1 analogue (77.6% vs 98.7%, risk ratio [RR] =0.47, 95% confidence intervals [95% CI] =0.38-0.59, P < 0.001) and additional PGE1 analogue for cervical ripening after one insertion (44.7% vs 68.0%, RR = 0.63, 95% CI = 0.46-0.86, P = 0.004) was significantly lower in Premaquick group. There was no significant difference in incidence of uterine rupture (0% vs 1.4%, RR = 0.000, P = 0.324); however, the frequency of transition to labor was statistically higher in Premaquick group (44.7% vs 22.7%, RR = 1.59, 95% CI = 1.17-2.15, P = 0.004). Interval from start of induction to any type of delivery, need for oxytocin augmentation, vaginal delivery, number of women with cesarean section for failed induction and number of infants admitted to neonatal intensive care unit were similar between the two groups (P > 0.05).
CONCLUSION: Preinduction cervical assessment with Premaquick was significantly associated with higher frequency of transition to labor and reduced need for PGE1 analogue when compared to modified Bishop score. Further similar trials in other settings are necessary to strengthen or refute this observation.
METHODS: A multicenter, double-blind randomized clinical trial in 151 nulliparous, cephalic presenting and singleton pregnancies was conducted. The cervix was considered 'ripe' when at least two out of three Premaquick biomarkers are positive or a Bishop score of ≥6. Main outcome measures were proportion of women who were administered or had additional prostaglandin E1 analogue (PGE1) as a preinduction agent and incidence of uterine rupture. The trial was registered in PACTR registry with approval number PACTR201604001592143. Analysis was performed by intention-to-treat principle.
RESULTS: The need for initial PGE1 analogue (77.6% vs 98.7%, risk ratio [RR] =0.47, 95% confidence intervals [95% CI] =0.38-0.59, P < 0.001) and additional PGE1 analogue for cervical ripening after one insertion (44.7% vs 68.0%, RR = 0.63, 95% CI = 0.46-0.86, P = 0.004) was significantly lower in Premaquick group. There was no significant difference in incidence of uterine rupture (0% vs 1.4%, RR = 0.000, P = 0.324); however, the frequency of transition to labor was statistically higher in Premaquick group (44.7% vs 22.7%, RR = 1.59, 95% CI = 1.17-2.15, P = 0.004). Interval from start of induction to any type of delivery, need for oxytocin augmentation, vaginal delivery, number of women with cesarean section for failed induction and number of infants admitted to neonatal intensive care unit were similar between the two groups (P > 0.05).
CONCLUSION: Preinduction cervical assessment with Premaquick was significantly associated with higher frequency of transition to labor and reduced need for PGE1 analogue when compared to modified Bishop score. Further similar trials in other settings are necessary to strengthen or refute this observation.