- Email: [email protected]
Medical and mechanical methods for cervical ripening
International Journal of Gynecology and Obstetrics 85 (2004) 159–160
Brief communication
Medical and mechanical methods for cervical ripening T. Biron-Shental*, A. Fishman, M.D. Fejgin Department of Obstetrics and Gynecology, Meir General Hospital, Kfar-Saba, Israel Received 23 June 2003; received in revised form 19 August 2003; accepted 27 August 2003 Keywords: Cervical ripening; PGE2; Intracervical catheter
When induction of labor is medically indicated and the status of the cervix is unfavorable, preinduction cervical ripening can increase success w1–4x. There are several methods for ripening of the cervix with no consensus on which method is best. In this study we compared the efficacy and safety of cervical ripening by 2 mg intra-vaginal prostaglandin E2 gel (PGE2), a double balloon device (DBC) (Atad Ripener Device; MR&D, Emerand Ltd., Rehovot, Israel) and the combination of the two methods in 77 singleton, term pregnancies with various medical indications for induction of labor in which the cervix was unripe (Bishop score 4 or less). The patient was assigned to one of three induction methods according to a computerized randomization list. We determined success of induction by the change in Bishop score or development of active labor without the addition of oxytocin. Effectiveness was determined as interval to delivery. Failure was defined as nonimproved Bishop score or need to add oxytocin in order to achieve active labor. Statistical analysis was performed with both the Student t-test and Fisher exact test. A P-value of less than 0.05 was *Corresponding author. Tel.: q972-9-747-2561; fax: q9729-747-2646. E-mail address: [email protected] (T. Biron-Shental).
considered significant. This study was approved by the institutional review board for human investigations. The indications for induction of labor are shown in Table 1. The patients in the three arms of the study were comparable for the proportion of primiparous women and initial Bishop score. Cervical ripening results are shown in Table 2. There was no difference between the groups in the change in the total Bishop score. However, PGE2 was more effective in changing the consistency of the cervix, while the catheter (alone or in combination with PGE2) was more effective in dilating the cervix. The shortest time interval between initiations of ripening to delivery was in the group of women in whom the combined method was used (P-0.05). The failure rate in the PGE2 group was significantly lower in comparison with the two other groups (P-0.05). The proportion of women who required oxytocin before entering the active phase of labor was similar in the three groups. Nine women (11.7%) delivered by cesarean section due to various reasons. There were no significant maternal or neonatal complications. Based on our experience and that of others, it seems that while the many single methods for cervical ripening are comparable, combining a
0020-7292/04/$30.00 䊚 2003 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijgo.2003.08.006
160
T. Biron-Shental et al. / International Journal of Gynecology and Obstetrics 85 (2004) 159–160
Table 1 Indications for cervical ripening Primipara
Multipara
Total
Post date Oligohydramnion IUGR Hypertension Diabetes mellitus Epilepsy
10 8 5 15 3 0
9 10 2 11 3 1
19 18 7 26 6 1
Total
41
36
77
Table 2 Cervical ripening results Ripening method
No. of women
First Bishop (mean)
Change in Bishop (mean)
Change in consistency (mean)
Change in effacement (mean)
Change in dilatation (mean)
Delivery interval (h, mean)
Failures (%)
PGE2 DBC Combined
27 26 24
2.5 2.3 2.5
3.5 3.11 3.12
0.74* 0.23 0.54
1.44 1.11 1.25
0.88 1.34* 1.04*
20.1 19.5 15.97*
1_27* (3.7%) 3_26 (11.5%) 2_24 (8.3%)
*Statistically significant advantage.
medical (prostaglandins) and a mechanical device is advantageous in achieving cervical ripening when induction of labor is attempted in the presence of an unripe cervix.
w2 x
w3 x
References w4 x w1x Atad J, Hallak M, Auslender R, Porat-Paker T, Zarfati D, Abramovici H. A randomized comparison of pros-
taglandin E2, oxytocin, and the double-balloon device in inducing labor. Obstet Gynecol 1996;87:223 –227. Boulvian M, Kelly A, Lohse C, Star C, Irion O. Mechanical methods for induction of labor. The Cochrane Library 2002;1. ACOG Practice Bulletin, number 10. Induction of labor. 1999. Kelly AJ, Kavanagh J, Thomas J. Vaginal prostaglandin (PGE2 and PGF2a) for induction of labor at term. The Cochrane Library 2002;1.
Brief communication
Medical and mechanical methods for cervical ripening T. Biron-Shental*, A. Fishman, M.D. Fejgin Department of Obstetrics and Gynecology, Meir General Hospital, Kfar-Saba, Israel Received 23 June 2003; received in revised form 19 August 2003; accepted 27 August 2003 Keywords: Cervical ripening; PGE2; Intracervical catheter
When induction of labor is medically indicated and the status of the cervix is unfavorable, preinduction cervical ripening can increase success w1–4x. There are several methods for ripening of the cervix with no consensus on which method is best. In this study we compared the efficacy and safety of cervical ripening by 2 mg intra-vaginal prostaglandin E2 gel (PGE2), a double balloon device (DBC) (Atad Ripener Device; MR&D, Emerand Ltd., Rehovot, Israel) and the combination of the two methods in 77 singleton, term pregnancies with various medical indications for induction of labor in which the cervix was unripe (Bishop score 4 or less). The patient was assigned to one of three induction methods according to a computerized randomization list. We determined success of induction by the change in Bishop score or development of active labor without the addition of oxytocin. Effectiveness was determined as interval to delivery. Failure was defined as nonimproved Bishop score or need to add oxytocin in order to achieve active labor. Statistical analysis was performed with both the Student t-test and Fisher exact test. A P-value of less than 0.05 was *Corresponding author. Tel.: q972-9-747-2561; fax: q9729-747-2646. E-mail address: [email protected] (T. Biron-Shental).
considered significant. This study was approved by the institutional review board for human investigations. The indications for induction of labor are shown in Table 1. The patients in the three arms of the study were comparable for the proportion of primiparous women and initial Bishop score. Cervical ripening results are shown in Table 2. There was no difference between the groups in the change in the total Bishop score. However, PGE2 was more effective in changing the consistency of the cervix, while the catheter (alone or in combination with PGE2) was more effective in dilating the cervix. The shortest time interval between initiations of ripening to delivery was in the group of women in whom the combined method was used (P-0.05). The failure rate in the PGE2 group was significantly lower in comparison with the two other groups (P-0.05). The proportion of women who required oxytocin before entering the active phase of labor was similar in the three groups. Nine women (11.7%) delivered by cesarean section due to various reasons. There were no significant maternal or neonatal complications. Based on our experience and that of others, it seems that while the many single methods for cervical ripening are comparable, combining a
0020-7292/04/$30.00 䊚 2003 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijgo.2003.08.006
160
T. Biron-Shental et al. / International Journal of Gynecology and Obstetrics 85 (2004) 159–160
Table 1 Indications for cervical ripening Primipara
Multipara
Total
Post date Oligohydramnion IUGR Hypertension Diabetes mellitus Epilepsy
10 8 5 15 3 0
9 10 2 11 3 1
19 18 7 26 6 1
Total
41
36
77
Table 2 Cervical ripening results Ripening method
No. of women
First Bishop (mean)
Change in Bishop (mean)
Change in consistency (mean)
Change in effacement (mean)
Change in dilatation (mean)
Delivery interval (h, mean)
Failures (%)
PGE2 DBC Combined
27 26 24
2.5 2.3 2.5
3.5 3.11 3.12
0.74* 0.23 0.54
1.44 1.11 1.25
0.88 1.34* 1.04*
20.1 19.5 15.97*
1_27* (3.7%) 3_26 (11.5%) 2_24 (8.3%)
*Statistically significant advantage.
medical (prostaglandins) and a mechanical device is advantageous in achieving cervical ripening when induction of labor is attempted in the presence of an unripe cervix.
w2 x
w3 x
References w4 x w1x Atad J, Hallak M, Auslender R, Porat-Paker T, Zarfati D, Abramovici H. A randomized comparison of pros-
taglandin E2, oxytocin, and the double-balloon device in inducing labor. Obstet Gynecol 1996;87:223 –227. Boulvian M, Kelly A, Lohse C, Star C, Irion O. Mechanical methods for induction of labor. The Cochrane Library 2002;1. ACOG Practice Bulletin, number 10. Induction of labor. 1999. Kelly AJ, Kavanagh J, Thomas J. Vaginal prostaglandin (PGE2 and PGF2a) for induction of labor at term. The Cochrane Library 2002;1.