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doi:10.1111/jog.12540
J. Obstet. Gynaecol. Res. Vol. 41, No. 3: 370–376, March 2015
Impact of prolonged dinoprostone cervical ripening on the rate of artificial induction of labor: A prospective study of 330 patients Christine Denoual-Ziad1, Stéphanie Aicardi-Nicolas2, Christian Creveuil3,4, Cathy Gaillard3,4, Michel Dreyfus1,4 and Guillaume Benoist1,4 1
Obstetrics and Gynecology Service, 3Biostatistics and Clinical Research Unit, 4University of Caen, Caen, and 2Obstetrics and Gynecology Service, Hospital of Arcachon, Arcachon, France
Abstract Aim: The aim of this study was to evaluate two regimens of administration of sustained-release dinoprostone on the need for oxytocin induction of labor. Material and Methods: We carried out an open prospective study comparing labor, maternal and neonatal outcomes after 12 h of prostaglandin cervical ripening insert versus 24 h of prostaglandin cervical ripening insert in 284 patients (142 ripenings at 12 h [P12 group] and 142 ripenings at 24 h [P24 group]). Results: The two groups were demographically similar. There was a significant difference in the need for artificial rupture of membranes/oxytocin induction of labor between the groups (49.3% for the P12 group vs 38% for the P24 group, P = 0.03). The delay between the beginning of ripening and delivery was significantly decreased in the P12 group, but the duration of active labor (6.6 h), the dose of oxytocics used (1326 UI), the rate of cesarean section, the rate of uterine hyperstimulation, the rates of hemorrhaging from delivery, the neonatal state and the experience of induction were similar in the two groups. Conclusion: This study allows us to show for the first time that sustained-release of dinoprostone leads to spontaneous induction of labor without increasing the obstetrical risk in a majority of patients. Key words: cervical ripening, dinoprostone, intra-vaginal administration, pregnancy, therapeutic use of, treatment outcome.
Introduction Artificial induction of labor (AIL) accounts for around 20% of childbirths in developed countries.1,2 The frequency of induced labor in France rose from 8.5% to 20.5% between 1972 and 2003.2 Two-thirds of these inductions are motivated by a medical indication. In half of these cases, cervical conditions, as evaluated by the Bishop score (BS), are unfavorable. In such cases, cervical ripening improves the rate of success of labor
induction. Numerous methods are available that aim to improve the success of AIL. Prostaglandins E2 are the primary medical means to ripening and have long proven their efficacy in labor induction.3 In 2003, a national study related to the obstetrical practice of inducing labor in France reported that recourse to prostaglandins was necessary in 45.8% of inductions. Cervical ripening before labor induction reduces complications due to prolonged labor as well as those due to the rate of cesarean sections (CS).4
Received: September 30 2013. Accepted: July 19 2014. Reprint request to: Dr Guillaume Benoist, Service de Gynécologie-Obstétrique et Médecine de la Reproduction, CHU de Caen, Pôle FEMME – ENFANT, Avenue de la Côte de Nacre, 14033 CAEN Cedex 9, France. Email: [email protected]; [email protected]
370
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
Dinoprostone and induction of labor
Early studies on the dinoprostone sustained-release vaginal insert (PROPESS, Ferring) pointed to a statistically significant efficacy of cervical ripening with a change in BS from 58% to 80% of cases, and efficacy of labor induction in 67% of patients.5–7 Efficacy is usually defined in the scholarship by a change of ≥3 points in the BS, or by spontaneous onset of labor during ripening.3 After 12 h of ripening, several authors have reported rates of spontaneous labor varying from 76% to 89%.8 Subsequently, studies have shown that this insert released dinoprostone for up to 24 h following application.9–11 We hypothesized that a decrease in the need for oxytocin induction of labor can be observed after 24 versus 12 h of prostaglandin insert. The aim of this study was therefore to compare the efficacy of two regimens of prostaglandin administration for cervical ripening on the rate of oxytocin induction of labor.
Methods This study reflects an open prospective study carried out in a university hospital (approximately 3000 births/year comprising 300 cervical ripening/ induction of labor procedures per year) over a period of 22 months (2010 to 2011), comparing the modes of delivery after administration of the 10-mg dinoprostone sustained-release vaginal insert (PROPESS) at 12 h (P12) and at 24 h (P24). The inclusion involved any patient over 18 years of age bearing a singleton offspring in cephalic presentation at term (≥37+0) and requiring labor induction for medical causes: post-term pregnancy (≥287 days, 41 weeks) and requiring labor induction for medical reasons. Exclusion criteria were a term 7 Neonatal nursery admission n (%) No Yes
P
P12 n = 142
P24 n = 142
72 (50.7%) 70 (49.3%) 17.1 ± 6.9 6.4 ± 3.3 94 (0–370) 2 (1–5)
88 (62.0%) 54 (38.0%) 22.2 ± 10.5 6.9 ± 4.0 63 (0–339) 3 (2–5)
131 (92.3) 11 (7.7)
130 (91.5) 12 (8.5)
NS
109 (76.8) 33 (23.2)
110 (77.5) 32 (22.5)
NS
118 (83.1) 24 (16.9)
116 (81.7) 26 (18.3)
NS
2 (1.4) 140 (98.6)
1 (0.70) 141 (99.3)
NS
132 (93.6) 9 (6.4)
135 (95.7) 6 (4.3)
NS
0.028
doi:10.1111/jog.12540
J. Obstet. Gynaecol. Res. Vol. 41, No. 3: 370–376, March 2015
Impact of prolonged dinoprostone cervical ripening on the rate of artificial induction of labor: A prospective study of 330 patients Christine Denoual-Ziad1, Stéphanie Aicardi-Nicolas2, Christian Creveuil3,4, Cathy Gaillard3,4, Michel Dreyfus1,4 and Guillaume Benoist1,4 1
Obstetrics and Gynecology Service, 3Biostatistics and Clinical Research Unit, 4University of Caen, Caen, and 2Obstetrics and Gynecology Service, Hospital of Arcachon, Arcachon, France
Abstract Aim: The aim of this study was to evaluate two regimens of administration of sustained-release dinoprostone on the need for oxytocin induction of labor. Material and Methods: We carried out an open prospective study comparing labor, maternal and neonatal outcomes after 12 h of prostaglandin cervical ripening insert versus 24 h of prostaglandin cervical ripening insert in 284 patients (142 ripenings at 12 h [P12 group] and 142 ripenings at 24 h [P24 group]). Results: The two groups were demographically similar. There was a significant difference in the need for artificial rupture of membranes/oxytocin induction of labor between the groups (49.3% for the P12 group vs 38% for the P24 group, P = 0.03). The delay between the beginning of ripening and delivery was significantly decreased in the P12 group, but the duration of active labor (6.6 h), the dose of oxytocics used (1326 UI), the rate of cesarean section, the rate of uterine hyperstimulation, the rates of hemorrhaging from delivery, the neonatal state and the experience of induction were similar in the two groups. Conclusion: This study allows us to show for the first time that sustained-release of dinoprostone leads to spontaneous induction of labor without increasing the obstetrical risk in a majority of patients. Key words: cervical ripening, dinoprostone, intra-vaginal administration, pregnancy, therapeutic use of, treatment outcome.
Introduction Artificial induction of labor (AIL) accounts for around 20% of childbirths in developed countries.1,2 The frequency of induced labor in France rose from 8.5% to 20.5% between 1972 and 2003.2 Two-thirds of these inductions are motivated by a medical indication. In half of these cases, cervical conditions, as evaluated by the Bishop score (BS), are unfavorable. In such cases, cervical ripening improves the rate of success of labor
induction. Numerous methods are available that aim to improve the success of AIL. Prostaglandins E2 are the primary medical means to ripening and have long proven their efficacy in labor induction.3 In 2003, a national study related to the obstetrical practice of inducing labor in France reported that recourse to prostaglandins was necessary in 45.8% of inductions. Cervical ripening before labor induction reduces complications due to prolonged labor as well as those due to the rate of cesarean sections (CS).4
Received: September 30 2013. Accepted: July 19 2014. Reprint request to: Dr Guillaume Benoist, Service de Gynécologie-Obstétrique et Médecine de la Reproduction, CHU de Caen, Pôle FEMME – ENFANT, Avenue de la Côte de Nacre, 14033 CAEN Cedex 9, France. Email: [email protected]; [email protected]
370
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
Dinoprostone and induction of labor
Early studies on the dinoprostone sustained-release vaginal insert (PROPESS, Ferring) pointed to a statistically significant efficacy of cervical ripening with a change in BS from 58% to 80% of cases, and efficacy of labor induction in 67% of patients.5–7 Efficacy is usually defined in the scholarship by a change of ≥3 points in the BS, or by spontaneous onset of labor during ripening.3 After 12 h of ripening, several authors have reported rates of spontaneous labor varying from 76% to 89%.8 Subsequently, studies have shown that this insert released dinoprostone for up to 24 h following application.9–11 We hypothesized that a decrease in the need for oxytocin induction of labor can be observed after 24 versus 12 h of prostaglandin insert. The aim of this study was therefore to compare the efficacy of two regimens of prostaglandin administration for cervical ripening on the rate of oxytocin induction of labor.
Methods This study reflects an open prospective study carried out in a university hospital (approximately 3000 births/year comprising 300 cervical ripening/ induction of labor procedures per year) over a period of 22 months (2010 to 2011), comparing the modes of delivery after administration of the 10-mg dinoprostone sustained-release vaginal insert (PROPESS) at 12 h (P12) and at 24 h (P24). The inclusion involved any patient over 18 years of age bearing a singleton offspring in cephalic presentation at term (≥37+0) and requiring labor induction for medical causes: post-term pregnancy (≥287 days, 41 weeks) and requiring labor induction for medical reasons. Exclusion criteria were a term 7 Neonatal nursery admission n (%) No Yes
P
P12 n = 142
P24 n = 142
72 (50.7%) 70 (49.3%) 17.1 ± 6.9 6.4 ± 3.3 94 (0–370) 2 (1–5)
88 (62.0%) 54 (38.0%) 22.2 ± 10.5 6.9 ± 4.0 63 (0–339) 3 (2–5)
131 (92.3) 11 (7.7)
130 (91.5) 12 (8.5)
NS
109 (76.8) 33 (23.2)
110 (77.5) 32 (22.5)
NS
118 (83.1) 24 (16.9)
116 (81.7) 26 (18.3)
NS
2 (1.4) 140 (98.6)
1 (0.70) 141 (99.3)
NS
132 (93.6) 9 (6.4)
135 (95.7) 6 (4.3)
NS
0.028
