None listed
Conditions
Brief summary
Vacuum extraction is a common procedure for assisting vaginal delivery. Traditionally, negative pressure application was recommended to be increased stepwisely. This trial aims to assess the effectiveness and safety of rapid versus stepwise negative pressure application for assisted vaginal delivery by vacuum extraction. This will be a hospital-based, multicentre, randomized controlled trial. Women eligible for the study are those with an uncomplicated singleton pregnancy of more than 34 weeks of gestation, with a cephalic presentation. Vacuum extraction procedure will be performed by application to the fetal head with a metal cup (Malmstrom, 50 mm) connected to an electric pump. The conventional stepwise method consists of four incremental steps of 0.2 kg/cm2 every two minutes to obtain a final negative pressure of 0.8 kg/cm2. In the rapid method the negative pressure of 0.8 kg/cm2 will be applied in one step in less than two minutes. When the final pressure has been achieved, traction will be undertaken during uterine contractions and maternal expulsive efforts. If there is detachment of the vacuum cup, it will be applied again, if clinically appropriate, to the fetal head in the manner indicated by the initial randomization. Thailand Research Fund by Senior Research Scholar will be responsible for funding and financial oversight of the centres. The trial will show whether rapid negative pressure application technique of vacuum extraction is as good as stepwise technique regarding effectiveness and safety.
Interventions
Rapid negative pressure application: negative pressure of 0.8 kg/cm2 will be applied in one step in less than two minutes. When the final pressure has been achieved, traction will be undertaken during uterine contractions and maternal expulsive efforts.
Sponsors
Kalasin Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Uncomplicated singleton pregnancy, more than 34 weeks of gestation, cephalic presentation.
Exclusion criteria
• Refusal to give informed consent • the woman is not entitled to give informed consent e.g. minors without a guardian • severe fetal distress( as defined by attending physicians)
Outcome results
None listed