An interventional study of balloon catheter combined with oxytocin induction in Macrosomia, Fetal, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-01-19.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Prevention
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.
32 studies on the registry are indexed under Fetal Macrosomia; 6 are open to participants now.
This study's planned enrollment of 150 is below the median of 222 across 13 interventional studies indexed under Fetal Macrosomia.
Browse Fetal Macrosomia studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.
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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 to vaginal delivery, estimated fetal weight >4500g
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: balloon catheter combined with oxytocin induction
Balloon catheter for 12 hours and oxytocin for up to 3days.If failed , they will be treated ceacrean.
vaginal birth rate
After spontaneous labor for up tp 24 hous, the mode of delivery will be konwn and recorded.
Time frame: 24 hours
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2022; primary completion for Jan 2023, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University →