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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nulliparous women with estimated fetal weight ≥3500g at 39-40 weeks of gestation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balloon catheter combined with oxytocin induction | Procedure | Balloon catheter for 12 hours and oxytocin for up to 3days.If failed , they will be treated ceacrean. |
|
| Measure | Description | Time Frame |
|---|---|---|
| vaginal birth rate | After spontaneous labor for up tp 24 hous, the mode of delivery will be konwn and recorded. | 24 hours |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziyan Jiang, doctor | Contact | 13512534017 | zyjiangchm@163.com | |
| Jinhai Tang | Contact |
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| ID | Term |
|---|---|
| D005320 | Fetal Macrosomia |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005315 | Fetal Diseases |
| D011254 | Pregnancy in Diabetics |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001724 | Birth Weight |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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