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Clinical study on the efficacy and safety of new obstetric air cushion combined with vasopressor for prevention and treatment of supine hypotension syndrome

A randomized controlled trial of a homemade obstetric air cushion for the treatment of hypotension during cesarean section spinal anesthesia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093721
Enrollment
Unknown
Registered
2024-12-10
Start date
2024-12-10
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obstetrics

Interventions

Vasopressor group:Intravenous infusion of norepinephrine
Fixed pressure air cushion combined with vasopressors group:An air cushion was placed between the upper and costal margins of the ilium and norepinephrine was administered intravenously
Air cushion groups with different pressure gradients:Air cushions with different pressure gradients were placed between the upper and costal margins of the iliac crest,Measurement of changes in the di

Sponsors

South Campus of Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. ASA I-II subjects; 2. Aged 20-40 years, weight 50-90kg, height 145-180cm; 3. Term singleton. 4. Elective cesarean section

Exclusion criteria

Exclusion criteria: 1.Multiple pregnancy 2.Suspected fetal injury 3.Combined with gestational hypertension or diabetes 4.Complicated with cardiovascular and cerebrovascular diseases 5.Coagulation dysfunction 6.Failure of spinal anesthesia

Design outcomes

Primary

MeasureTime frame
Norepinephrine dosage;

Secondary

MeasureTime frame
Incidence of hypotension;Measurement of the change of inferior vena cava diameter by Doppler ultrasound;Umbilical cord blood gas;Incidence of nausea and vomiting;Newborn birth status;Bradycardia incidence;

Countries

China

Contacts

Public ContactWeng Hao

South Campus of Shanghai Sixth People's Hospital

18018821130@163.com+86 180 1882 1130

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026