Premaquick© versus modified Bishop score for preinduction cervical assessment at term: A double‐blind randomized trial

• Published in: The journal of obstetrics and gynaecology research 2018-08, Vol.44 (8), p.1404-1414
• Main Authors: 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.
• Format: Article
• Language: English
• Subjects: Adult; Biomarkers; cervical assessment; Cervical Ripening - drug effects; Cervix; Cesarean section; Clinical trials; Double-Blind Method; Double-blind studies; Female; Humans; induction; Infants; labor; Labor, Induced - statistics & numerical data; modified Bishop score; Motivation; Neonates; Nigeria - epidemiology; Obstetrics - methods; Obstetrics - standards; Outcome Assessment (Health Care); Oxytocics - therapeutic use; Oxytocin; Pregnancy; Premaquick; Prostaglandin E1; Prostaglandins - therapeutic use; Ripening; Rupture; Uterine Rupture - epidemiology; Uterus; Vagina; Young Adult
• ISSN: 1341-8076; 1447-0756
• DOI: 10.1111/jog.13691

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  0.05). 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.