CNAP vs IABP in Pregnant Women With Placenta Accreta

October 20, 2025 updated by: Phillip Hess, Beth Israel Deaconess Medical Center

Comparison of Continuous Non-Invasive Arterial Blood Pressure to Invasive Arterial Blood Pressure Measurement in Pregnant Women With Placenta Accreta

The objective of this study is to investigate a technique to monitor blood pressure in women undergoing cesarean delivery with suspected placenta accreta spectrum. To achieve this objective, the investigators plan to conduct a prospective, observational study with the following aims:

Specific Aim 1: Compare concordance between the systolic (SBP), diastolic (DBP), and mean arterial blood pressure (MAP) readings from the continuous non-invasive arterial blood pressure (CNAP) and IABP at several discrete points throughout the procedure

Specific Aim 2: Determine the feasibility of using CNAP to aid in decision making by examining the parameters of volume responsiveness and arterial elastance at several discrete points throughout the procedure.

The investigators hypothesize that the investigators can obtain similar blood pressure monitoring using CNAP as compared to the gold standard IABP in women undergoing cesarean delivery with suspected placenta accreta.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Study Overview This is a prospective, observational study.

Study Procedures Patients who meet inclusion criteria with no exclusions will be approached to provide written informed consent.

Enrolled patients will undergo the standard pre-operative evaluation and preparation for cesarean section with possible hysterectomy including evaluation by nursing, obstetrics and anesthesiology team, placement of 2 large bore IVs, arterial line placement and laboratory tests.

The patient will then be transported to the OR. In the OR the CNAP device will be placed on the patient's finger and be given a brief calibration period of 45 seconds. As per usual for this procedure, each patient will undergo combined spinal epidural anesthesia with our standard cesarean induction dose of hyperbaric intrathecal 0.75% bupivacaine 1.5ml, intrathecal fentanyl 25 micrograms and intrathecal morphine 250 micrograms. The patient will be moved to the supine position with left lateral uterine displacement. When a T6 sensory level to pinprick is achieved, surgery will be allowed to proceed. Throughout the surgery, the CNAP and IABP will take continuous reading of blood pressure and hemodynamic variable. Labs and additional fluid or blood may be given to the patient as clinically indicated, as is common for this procedure. Blood work will be obtained from the arterial line used for IABP, as is standard practice when an AIBP is in place. Other than the addition of the CNAP cuff, all other care will be per standard protocol for this procedure.

Data Collection In order to assess our primary and secondary outcomes, the investigators will be collecting CNAP and AIBP. Additional baseline characteristics including, but not limited to age, race, gender, BMI and comorbidities will be abstracted from the medical record. REDCap will be utilized for data collection and storage.

Primary Outcomes SBP, MAP, DBP reading from the CNAP and AIBP at several discrete points throughout the procedure.

Secondary Outcomes Additional comparisons of SBP, MAP, DBP measurements using CNAP to AIBP and NIBP, review of extrapolated data outputs including Stroke Volume, Systemic Vascular Resistance, Cardiac Output and Stroke Volume Variation from CNAP compared pulse pressure index from pulse oximetry and AIBP and their responsiveness to fluid bolus, subgroup analysis of CNAP and AIBP during times significant intravascular volume depletion (blood loss) or systemic vascular resistance change (after spinal anesthesia). Relevant clinical data will also be collected, including; demographic data, total estimated blood lose, total quantitative blood loss, length of hospital stay, routine lab results including; Hematocrit, Fibrinogen, coagulation tests, lactic acid, pH, base excess.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women undergoing cesarean delivery with suspected placenta accreta spectrum.

Description

Inclusion Criteria:

  • Women aged 18-40 years old with pregnancy complicated by accreta spectrum undergoing elective, scheduled cesarean delivery and possible hysterectomy

Exclusion Criteria:

  • Women aged <18
  • Patients with cardiac arrhythmia
  • Vascular pathologies of the upper limbs (recent vascular surgery, Reynaud's disease, vascular stenosis)
  • Contraindication to neuraxial anesthesia
  • Emergent cases
  • Droplet or airborne precautions (as determined by BIDMC infection control policy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women with suspected placenta accreta
Pregnant women undergoing cesarean delivery with suspected placenta accreta spectrum.
Device: LiDCO CNAP Monitoring Equipment
A continuous non-invasive arterial blood pressure monitor for rapidly changing hemodynamics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing concordance between MAP from the CNAP and AIBP
Time Frame: MAP will be measured continuously throughout the operative case, with an average case timeframe of 4-6 hours.
Comparing concordance of systolic blood pressure, mean arterial blood pressure, and diastolic blood pressure readings captured from the continuous non-invasive arterial blood pressure measurements and invasive arterial blood pressure measurements.
MAP will be measured continuously throughout the operative case, with an average case timeframe of 4-6 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional Comparisons of SBP and DBP
Time Frame: SBP and DBP will be measured continuously throughout the operative case, with an average case timeframe of 4-6 hours.
SBP and DBP will be measured continuously throughout the operative case, with an average case timeframe of 4-6 hours.
Stroke Volume
Time Frame: Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Review of extrapolated data outputs to assess the volume of blood ejected from each ventricle due to the contraction of the heart muscle which compresses these ventricles, measurements in millilitres.
Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Systemic Vascular Resistance
Time Frame: Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Review of extrapolated data outputs to assess changes in the arterioles.
Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Cardiac Output
Time Frame: Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Review of extrapolated data outputs to assess heart rate product.
Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Stroke Volume Variation
Time Frame: Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Review of extrapolated data outputs assessing the change in the amount of blood ejected from the left ventricle into the aorta with each heartbeat
Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Subgroup analysis of CNAP and AIBP
Time Frame: Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Analysis of continuous non-invasive arterial blood pressure measurements and invasive arterial blood pressure measurements during times significant intravascular volume depletion (blood loss) or systemic vascular resistance change (after spinal anesthesia). This will include the above derived variables (SV, SVR, CO, SVV) and compare them to pulse pressure variation to assess potential value of these measures in the assessment volume depletion and fluid responsiveness.
Measured throughout the operative case, with an average case timeframe of 4-6 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: John J. Kowalczyk, MD, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

June 1, 2025

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Estimated)

October 21, 2025

Last Update Submitted That Met QC Criteria

October 20, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P001099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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