Macrosomia, Fetal
Conditions
Keywords
balloon catheter, oxytocin
Brief summary
This study is a randomized, controlled, observational study. 150 nulliparous women with estimated fetal weight ≥3500g at 39-40 weeks of gestation will be enrolled as subjects in the two groups is 1:1. In the experimental group, vaginal examination will be performed at 39 to 40 weeks to assess cervical conditions. If the bishop score \<6, the balloon catheter combined with oxytocin induction will be planned at 40 weeks ±3 days. In the control group, one week to 41 weeks ±3 days will be expected. Vaginal examination will be performed again to evaluate cervical conditions. If the bishop score \<6 points, and balloon catheter combined with oxytocin induction will be performed. 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
PROCEDUREballoon catheter combined with oxytocin induction
Balloon catheter for 12 hours and oxytocin for up to 3days.If failed , they will be treated ceacrean.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
singleton head position pregnancy, negative Down's screening and /or NIPT screening, no malformation was found, with slight/without pregnancy complications -
Exclusion criteria
twin or multiple pregnancy, scar uterus, with contraindications to vaginal delivery, estimated fetal weight \>4500g \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| vaginal birth rate | 24 hours | After spontaneous labor for up tp 24 hous, the mode of delivery will be konwn and recorded. |
Contacts
Primary ContactZiyan Jiang, doctor
Backup ContactJinhai Tang
Outcome results
None listed