randomized study on doubleballoon catheter versus dinoprostone vaginal
randomized study on doubleballoon catheter versus dinoprostone vaginal insert for induction of labor with an unfavorable cervix Dr. Gonca Yetkin Yıldırım, Dr. Nadiye Koroglu, Dr Ahmet Tayyar, Dr. Gözde Demirezen University of Health Science KSS Education and Research Hospital
Purpose �To compare a double- balloon transcervical catheter and dinoprostone vaginal insert for induction of labour in women with an unfavorable cervix
Materials and Methods-I Patients assessed for eligibility: �Singleton gestation �Vertex presentation �Bishop score of ≤ 6 �≥ 34 weeks �Intact membranes �Requiring labor induction due to maternal or fetal indications received either a double-balloon catheter or a dinoprostone vaginal insert from November 2016.
Materials and Methods-II Exclusion criteria: �Antepartum bleeding �Nonvertex presentation �Intrauterine fetal death �Prior uterine scars �Plasenta previa
Materials and Methods-III �Double balloon catheter is inserted into cervical canal under direct visualization. Once both balloon enter the cervical canal first balloon is filled with 40 ml , the second balloon is filled with 20 ml of saline. Then both of them are filled with 60 ml saline. The external end of the device is taped without traction to the medial aspect of the woman’s thigh. �Vaginal insert is placed high in the vaginal fornix �Patients are monitored at least 1 hour �After 12 hours oxytocin is administered using a standart dose regimen to all patients.
Results-1 �A total of 73 women were included. 36 received induction with a doubleballoon catheter and 37 with the dinoprostone vaginal insert. � The groups were similar with respect to maternal age, body mass index, gravidity, parity, baseline bishop score, and indications for induction.
Results-II � Gestational age at induction was similar between the groups (doubleballoon 39. 41± 2. 14 weeks, dinoprostone 39. 60± 1. 67 weeks, p=0. 646 �There was no difference in the vaginal delivery rate within 24 hours ( 52. 5 vs 47. 5 %, p=0. 551)between the groups. Maternal outcomes were similar between the groups.
Demographic characteristics and induction outcomes Double- balloon catheter, n=36 Dinoprostone vaginal insert, n=37 P value Maternal age 28. 09± 6. 21 26. 59± 4. 48 0. 250 Gravida 2. 30± 1. 68 1. 97± 0. 89 0. 294 Parity 1. 13± 1. 57 0. 67± 0. 85 0. 120 Gestational age 39. 41± 2. 14 39. 62± 1. 67 0. 646 Bishop score 2. 38± 0. 80 2. 51± 0. 76 0. 500 Cervical length 36. 16± 5. 02 35. 10± 3. 94 0. 319 Vaginal delivery within 24 h (n, %) 21(52. 5) 19(47. 5) 0. 551 BMI 28. 1± 4. 4 29. 2± 5. 4 0. 860 Vaginal delivery rate(n, %) 22(47. 8) 24(52. 2) 0. 840
Demographic characteristics and induction outcomes Reason for induction Double balloon catheter, n=36 Dinoprostone vaginal insert, n=37 P value Postterm pregnancy ≥ 41 42. 8% 44. 7% 0. 89 Hypertensive disorders 19% 16% 0. 72 Olıgohdramnios 6. 7% 6. 8% 1. 0 Intrauterine growth restriction 7. 6% 4. 8% 0. 57 Others 4. 8% 3. 9% 1
Conclusion �Double-balloon catheter and dinoprostone vaginal insert associated with similar vaginal delivery and cesarean section rates
�aa
�Objective: To compare the safety and efficacy of double balloon catheter with prostaglandin E 2 agents used for labor induction �Selection criteria: Only RCT comparing two methods
�Main results: Nine studies (1866) were included in this study. Both the double balloon catheter and PGE 2 agents were comparable with regard of rate of cesarean section, vaginal delivery within 24 hours and maternal adverse events, but the risk of excessive uterine activity and the need for neonatal intensive care unit admissions were significantly increased in women who received PGE 2 agents
�Conclusion: The double- balloon catheter demonstrated greater safety and cost effectiveness than PGE 2 agents for cervical ripening an labour induction. �The efficacy profiles of both methods were similar.
TESEKKURLER
- Slides: 18