Trial of Labor After Cesarean, Vaginal Birth After Cesarean, Bishop Score, Failed Mechanical Induction, Balloon Catheter for Labor Induction, Unfavorable Cervix
Conditions
Brief summary
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.
Interventions
DEVICEBalloon catheter
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.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Volunteers sign the informed consent; 2. Age: 20-40 years; 3. Singleton, a cephalic presentation; 4. No contradiction to vaginal delivery; 5.39\ 42 weeks.
Exclusion criteria
1. Konwn contraindication to vaginal delivery or severe complications; 2. Multiple gestation; 3. Uterine malformation; 4. Severe psychiatric disorder; 5. Without family's support.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| vignial birth rate | up to 84 hours | 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. |
Countries
China
Contacts
Primary ContactJiang Ziyan, Ph.D
Outcome results
None listed