Blood Loss Measurement During Cesarean Delivery



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 50
Updated:9/7/2018
Start Date:May 2016
End Date:December 12, 2017

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Study Assessing Blood Loss Measurement During Cesarean Delivery With Triton Device

The aim of this study is to assess the ability of the Triton Device to measure blood loss
among women undergoing elective and non-elective cesarean delivery. This patient population
often experiences significant blood loss during surgery, and measurements of surgical blood
loss are often inaccurate.

This is an observational study. Potential participants will be approached by a member of the
research team prior to surgery. Healthy ASA 1, 2, or 3 patients undergoing uncomplicated
Cesarean delivery will be recruited. The Triton device will be used during the surgery to
estimate blood loss. Specifically, the device takes pictures of the blood saturated laps and
fluid collection canister and calculates hemoglobin loss and overall blood loss.

Serum hemoglobin samples will be collected at baseline on presentation to the pre-operative
area, within 15 mins of arrival in PACU and at 24 hrs post cesarean delivery. Blood sampling
will take place by venipuncture technique from a vein in the arm. Maternal vital signs during
the perioperative period (heart rate, maternal mean arterial blood pressure, anesthetic
technique, fluid administration, and surgical data will be recorded.

All patient will have a neuraxial anesthetic of a spinal or combined spinal/epidural. Fluid
administration will be under the discretion of the anesthesiologist and will follow standard
guidelines including 1L of Lactated Ringers co-load at time of spinal and 1-2L of crystaloid
intraoperatively.

At the end of the cesarean section, the following measurements will be made:

1. tEBL: Triton device will be used to measure blood loss on wet and dry soaked laps and in
the suction canister. These measurements will be used to calculate tEBL.

2. vEBL: The attending obstetrician and anesthesiologist will independently be asked to
provide estimates for total blood loss (vEBL). We will use both values in separate
regression analyses

3. qEBL: Blood loss will be measured by cumulative measurement of the following: the volume
of blood in the suction chamber at the end of surgery (and subtracting the estimated
amniotic fluid from the suction chamber; weight of blood soaked laps; estimated spillage
of blood (in ml) in and around the surgical field (not collected on laps or in suction
chamber).

Using mixed effects modeling, we will determine whether estimated blood loss measurements
using Triton (tEBL) can be used to predict postpartum hemoglobin (Hb) levels, after
accounting for the predelivery Hb level, intraoperative intravenous fluids and
patient/operative factors.

Inclusion Criteria:

- American Society of Anesthesiologists physical status class I-III

- undergoing Cesarean delivery under neuraxial anesthesia

- age between 18 and 50

- gestational age greater than or equal to 37 completed weeks

- all ethnicities

Exclusion Criteria:

- contraindication for epidural or spinal analgesia (bleeding diathesis, neuropathy,
severe scoliosis, local anesthetic allergy)

- inability to adequately understand the consent form
We found this trial at
1
site
Palo Alto, California 94304
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Palo Alto, CA
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