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This study is a multi-center, prospective, observational clinical trial study. 924 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1. In the prior cesarean section group, pregnant women with one previous cesarean section who are willing to try to the trial of labor after cesarean (TOLAC) and in accordance with the criteria according to the 2016 China vaginal birth after cesarean (VBAC) clinical management guidelines will be enrolled and recorded by our homemade registration form of TOLAC. In the control group, pregnant women after 39 weeks of gestation without vaginal labor contraindications will be enrolled. Whether in the experimental group or the control group, their cervical bishop score was less than 6 points, and they all will be induced by balloon catheter + oxytocin. After 96h, their final delivery mode will be recorded. In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cesarean section group | In the cesarean section group, all the pregnant women had only one prior cesarean section. |
| |
| Non-cesarean section group | In the non-cesarean section group, all the pregnant women are primipara,and never had a cesarean section. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balloon catheter | Device | In the two groups, if their bishop score <6, they will receive the cervical riening by the balloon catheter, and then the oxytocin if necessary. |
|
| Measure | Description | Time Frame |
|---|---|---|
| vignial birth rate | After the treatment of balloon catheter for 12 hours +oxytocin induction for up tp 72 hours, the mode of delivery will be konwn and recorded. | up to 84 hours |
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Inclusion Criteria:
Exclusion criteria:
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In the cesarean section group, the extra inclusion criteria includes:
Only one prior low transverse uterine incision;
Extra exclusion criteria:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Ziyan, Ph.D | Contact | 13512534017 | zyjiangchm@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiang Ziyan, Ph.D | Department of Obstetrics and Gynecology, First Affiliated Hospital of Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30723900 | Background | Huisman CMA, Ten Eikelder MLG, Mast K, Oude Rengerink K, Jozwiak M, van Dunne F, Duvekot JJ, van Eyck J, Gaugler-Senden I, de Groot CJM, Franssen MTM, van Gemund N, Langenveld J, de Leeuw JW, Oude Lohuis EJ, Oudijk MA, Papatsonis D, van Pampus M, Porath M, Rombout-de Weerd S, van Roosmalen JJ, van der Salm PCM, Scheepers HCJ, Sikkema MJ, Sporken J, Stigter RH, van Wijngaarden WJ, Woiski M, Mol BWJ, Bloemenkamp KWM; PROBAAT-S project group. Balloon catheter for induction of labor in women with one previous cesarean and an unfavorable cervix. Acta Obstet Gynecol Scand. 2019 Jul;98(7):920-928. doi: 10.1111/aogs.13558. Epub 2019 Mar 7. | |
| 29490397 |
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| Background |
| Battarbee AN, Palatnik A, Peress DA, Grobman WA. The Association between Cervical Exam after Ripening with Foley Balloon Catheter and Outcomes of Nulliparous Labor Induction. Am J Perinatol. 2018 Aug;35(10):1001-1005. doi: 10.1055/s-0038-1635091. Epub 2018 Feb 28. |