Trials / Unknown
UnknownNCT05246761
Balloon Catheter Combined With Oxytocin Induction Among the Pregnant Women With Previous Cesarean Section
To Study the Effectiveness and Safety of Balloon Catheter Combined With Oxytocin Induction Among the Pregnant Women With Previous Cesarean Section: Multicenter, Prospective, Observational Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 924 (estimated)
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University · Academic / Other
- Sex
- Female
- Age
- 20 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Trial of Labor After Cesarean
- Vaginal Birth After Cesarean
- Bishop Score
- Failed Mechanical Induction
- Balloon Catheter for Labor Induction
- Unfavorable Cervix
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Balloon 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. |
Timeline
- Start date
- 2022-01-30
- Primary completion
- 2023-06-30
- Completion
- 2024-12-30
- First posted
- 2022-02-18
- Last updated
- 2022-04-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05246761. Inclusion in this directory is not an endorsement.