Natural delivery
Conditions
Interventions
Bionic balloon-assisted group:Bionic balloon-assisted
Control group:Natural delivery
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-45 years; 2.Nulliparous women with singleton, term pregnancy, cephalic presentation, and no contraindications to vaginal delivery; 3.Latent phase longer than 3 hours, cervical dilation greater than 4-5 cm (entry into the active phase), fetal head engagement, and no obvious cephalopelvic disproportion; 4.Voluntary participation in this study and signing of written informed consent.
Exclusion criteria
Exclusion criteria: 1.Multiparous women; 2.Non-cephalic presentation; 3.Genital tract infection; 4.High-risk pregnancy score classified as "red ball," "purple ball," or some "orange ball" categories, including severe medical or surgical comorbidities, placenta previa, scarred uterus, etc.; 5.Presence of cephalopelvic disproportion, abnormal fetal heart rate, or other conditions unsuitable for vaginal delivery and requiring cesarean section; 6.Other conditions considered unsuitable for enrollment by the clinician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the duration of labor; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intrapartum cesarean conversion rate;Incidence of postpartum depression;Neonatal outcomes, including birth weight, Apgar scores at 1, 5, and 10 minutes, umbilical artery blood gas analysis results, and neonatal complications;Incidence of postpartum pelvic floor dysfunction;Incidence of intrapartum and postpartum complications;Patient satisfaction; | — |
Countries
China
Contacts
Public ContactZhong Yifeng
Peking Union Medical College Hospital
Outcome results
None listed