Comparing blood pressure targets for preeclamptic patients during cesarean sections
Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Neonatal Outcomes in Preeclamptic Patients During Cesarean Section
This study is testing if keeping blood pressure at a higher level during cesarean sections can improve the health of newborns for mothers with preeclampsia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | General Hospital of Ningxia Medical University Academic / other |
| Locations | 1 site (Yinchuan, Ningxia) |
| Trial ID | NCT06151431 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of different maternal blood pressure maintenance targets on neonatal outcomes in preeclamptic patients undergoing cesarean sections. It addresses the common complication of post-spinal anesthesia hypotension, which can occur in a significant percentage of cases without proper management. The research will compare the standard practice of maintaining blood pressure above 80% of baseline with a more intensive target of above 90% of baseline, utilizing alpha-adrenergic receptor agonists as a treatment strategy. The goal is to determine if stricter blood pressure control can lead to better outcomes for newborns.
Who should consider this trial
Good fit: Ideal candidates are preeclamptic women aged 18-45, scheduled for cesarean section under spinal anesthesia, with singleton pregnancies of at least 32 weeks.
Not a fit: Patients with chronic hypertension, eclampsia, or significant fetal distress may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved neonatal outcomes for preeclamptic patients undergoing cesarean sections.
How similar studies have performed: While the approach of maintaining blood pressure above 90% of baseline is suggested, limited evidence exists to support its advantages over the standard practice, making this study a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-45 years * Primipara or multipara * Singleton pregnancy ≥32 weeks * American Society of Anesthesiologists physical status classification I to III * Scheduled for cesarean section under spinal anesthesia Exclusion Criteria: * Baseline blood pressure ≥160 mmHg * Body height \< 150 cm * Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2 * Eclampsia or chronic hypertension * Hemoglobin \< 7g/dl * Fetal distress, or known fetal developmental anomaly
Where this trial is running
Yinchuan, Ningxia
- General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (Recruiting)
Study contacts
- Study coordinator: Yi Chen, M.D.
- Email: czzyxgp@163.com
- Phone: 86-951-674-3252
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.