1. Preliminary results of a randomized study on double-balloon 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

2. Purpose
To compare a double- balloon transcervical catheter and dinoprostone vaginal insert for induction of labour in women with an unfavorable cervix

3. Materials and Methods-I
Patients assessed for eligibility:
Singleton gestation
Vertex presentation
Bishop score of ≤ 6
≥34weeks
Intact membranes
Requiring labor induction due to maternal or fetal indications received either a double- balloon catheter or a dinoprostone vaginal insert from November

4. Materials and Methods-II
Exclusion criteria:
Antepartum bleeding
Nonvertex presentation
Intrauterine fetal death
Prior uterine scars
Plasenta previa

5. 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.

6. Results-1
A total of 73 women were included. 36 received induction with a double- balloon 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.

7. Results-II
Gestational age at induction was similar between the groups (double-balloon ±2.14 weeks, dinoprostone ±1.67 weeks,p=0.646
There was no difference in the vaginal delivery rate within 24 hours ( 52.5 vs %, p=0.551)between the groups. Maternal outcomes were similar between the groups.

8. 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

9. 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
3.9% 1

10. Conclusion
Double-balloon catheter and dinoprostone vaginal insert associated with similar vaginal delivery and cesarean section rates

11. aa

14. Objective:To compare the safety and efficacy of double balloon catheter with prostaglandin E2 agents used for labor induction
Selection criteria: Only RCT comparing two methods

16. Main results:Nine studies (1866) were included in this study
Main results:Nine studies (1866) were included in this study.Both the double balloon catheter and PGE2 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 PGE2 agents

17. Conclusion: The double- balloon catheter demonstrated greater safety and cost effectiveness than PGE2 agents for cervical ripening an labour induction.
The efficacy profiles of both methods were similar.

18. TESEKKURLER