Clinical trial NCT02902068: Hemodynamic Monitoring in Women Throughout Cesarean Sections
Official title: Maternal Hemodynamic Monitoring in Women Undergoing Cesarean Section by Use of NICaS Cardiac Impedance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamics
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy and hypertensive women above 18 undergoing cesarean section deliveries.

Brief summary: In this study we would like to monitor cardiac output by the use of NICAS bioimpedance in women undergoing cesarean section delivery.

This study is a purely observational study, it will not have any clinical intervention nor will it interfere with standard cesarean delivery protocols in any way. This study's primary objective is to evaluate how spinal and general anesthesia influences cardiac output during cesarean section deliveries. Secondary endpoints is whether the hemodynamic changes as measured in cardiac output correlate with women's pain, measured by a visual analogue scale(VAS) from o-10. (0=representing no pain at all, 10= worse pain imaginable)

Detailed description: This is a prospective, single center study which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital. The Institutional Review Board has approved this study.

Two hundred women undergoing cesarean sections will be enrolled after filling out an informed consent form. Women will be recruited half an hour preoperatively in the women's surgery waiting room when they aren't experiencing any pain, and aren't under any sedatives.

Following obtaining an informed consent maternal cardiac output will be monitored.

The monitoring will be carried out using non invasive NICaS cardiac impedance by the use of two electrodes stickers which are pasted on the wrists for about 6 minutes.

Monitoring will be done with women lying down or sitting up half an hour preoperatively (in the woman's surgery waiting room) intraoperatively, and postoperatively in the post anesthesia care unit (PACU).

Preoperative data will be compared to intraoperative and postoperative data, and will be analyzed in order to evaluate the dynamic cardiac output changes in women undergoing cesarean sections.

Recorded data will include:

* Demographic and obstetric - age, weight, height, current hemoglobin, co-morbidities, regular medication and other obstetric data.
* Cardiovascular risk factors - a family history of cardiovascular disease, smoking, BMI
* Obstetric history - obstetric background (history of gestational diabetes, preeclampsia, intrauterine growth restriction (IUGR), stillbirths or placental abruption).
* Threshold of pain according to VAS It should be emphasized that the conduct of the study will not interfere in with cesarean delivery protocol in any way.

Eligibility criteria: Inclusion Criteria:

- All women undergoing cesarean section in Beilinson Hospital following obtaining written informed consents forums with the ability to comply to the study requirements will be included in our study.

Exclusion Criteria:

- Women under age 18 , and women who don't understand the inform consent form will be excluded from participating.

Primary outcomes:
measure: Hemodynamic changes in cesarean section as measured by NICaS parameters.
timeFrame: A year
Secondary outcomes:
measure: Hemodynamic changes measured by NICaS parameters and their correlation with pain in women undergoing cesarean sections as measured by VAS.
timeFrame: A year
Other outcomes:
Locations:
city: Petach tikvah
country: Israel
facility: Beilinson hospital
Study officials:
References:
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