Recruiting

Fluids

Sponsor:

Baylor College of Medicine

Code:

NCT04330742

Conditions

Pregnancy Related

Hemorrhage

Fluid Overload

Labor Complication

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

lactated ringers

Study Details

Brief summary:

Pregnancy is associated with a myriad of physiologic changes, including expansion of blood volume, decrease in oncotic pressure, and increased cardiac output. The obstetric population is associated with intrapartum hemorrhage. Accordingly, it is important to have an accurate method to assess fluid status in intrapartum patients. The use of standard volume assessment tools including arterial lines and central venous catheters is limited given the brevity of obstetric procedures and the morbidity of these techniques on the awake patients, and the costs. Non-invasive methods to assess volume status (carotid dopplers, direct measurement of blood loss, bio-impedance devices) are imperfect. Echocardiography is an attractive tool to measure fluid status in experienced operators such as anesthesiologists. IVC diameter and variation of aortic velocity time integral are two measures that can be obtained via echocardiography and been studied in spontaneously breathing patients. The purpose of this study is to determine whether these measurements can be used in the assessment of volume status in the laboring patient.

Conditions

Pregnancy Related

Hemorrhage

Fluid Overload

Labor Complication

Study ID

NCT04330742

Start date

Mar 25, 2020

Status verified date

Apr, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

0 mL crystalloid

These are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 0, at which time 0 mL of fluids will have been administered.

250 mL crystalloid.

These are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 1, after the spinal has been placed and approximately 250 mL fluids has been administered.

500 mL crystalloid

These are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 2, at which time 500 mL of fluids will have been administered.

1000 mL crystalloid

These are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 3, at which time 1000 mL of fluids will have been administered.

Interventions

lactated ringers

the intervention is one liter fluid bag of lactated ringers which is routinely used as a fluid coload for spinal anesthesia. All patients will receive the same amount of fluids however this will be paused at various time points in order to perform the echocardiogram.

Primary outcome measure

  • aortic velocity time integral [ Time Frame: at baseline measure, right after spinal placement (250mL LR), at 500mL LR infusion, and at 1 L LR infusion (approximately 20mins) ]

Central Contacts and Locations

Central contacts

Amy Lee, MD

713-793-8805amy.lee@bcm.edu

Claudia Wei, MD

cwei@bcm.edu

Locations

Ben Taub General Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Claudia Wei, MD

cwei@bcm.edu

Amy Lee, MD

713-793-8805Amy.Lee@bcm.edu

Principal Investigator:

Amy Lee, MD

More Information

Sponsor

Baylor College of Medicine

Last update posted

Apr 22, 2024

Last verified

Apr, 2024

Keywords

  • obstetrics
  • fluid responsiveness
  • fluid resuscitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2024-04-22.