Assessing fluid effects during Cesarean delivery
The Influence of Intravascular Fluid Administration on Aortic Velocity Time Integral in Obstetric Patients Undergoing Cesarean Section
This study is testing how giving fluids during Cesarean deliveries affects blood flow in pregnant women to help improve care in case of complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04330742 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of fluid administration on aortic velocity time integral (VTI) during Cesarean sections in pregnant women. It aims to improve the assessment of fluid status in intrapartum patients, particularly in the context of potential hemorrhage and the physiological changes associated with pregnancy. The study utilizes echocardiography to measure fluid responsiveness, focusing on non-invasive techniques that can be safely applied in the obstetric population. By evaluating healthy pregnant women scheduled for elective Cesarean delivery, the study seeks to enhance understanding of fluid management in this high-risk group.
Who should consider this trial
Good fit: Ideal candidates are healthy pregnant women aged 18-35, at term, scheduled for elective Cesarean delivery with planned neuraxial anesthesia.
Not a fit: Patients with significant comorbidities, emergency Cesarean sections, or those outside the specified age and BMI criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved fluid management strategies during Cesarean deliveries, potentially reducing complications related to fluid overload and hemorrhage.
How similar studies have performed: While the use of echocardiography for fluid assessment in obstetrics is gaining interest, this specific approach remains relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * healthy nulliparous or multiparous pregnant women with a term (\>37 weeks gestation) * age 18-35 * singleton pregnancy * scheduled for Cesarean delivery with planned neuraxial spinal or combined spinal epidural anesthesia * American Society for Anesthesiologists physical status 2 Exclusion Criteria: * Patients without ability to provide informed consent * American Society for Anesthesiologists physical status 3 or 4 * Emergency cesarean section * BMI\>40 * Known cardiac and pulmonary comorbidities including chronic hypertension, preeclampsia, gestational hypertension, diabetes, asthma, renal disease * Age \> 35
Where this trial is running
Houston, Texas
- Ben Taub General Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Amy Lee, MD — Baylor College of Medicine
- Study coordinator: Amy Lee, MD
- Email: amy.lee@bcm.edu
- Phone: 713-793-8805
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.