CNAP vs IABP in Pregnant Women With Placenta Accreta

NCT04671680 | Terminated DMC FDA Device

• 1 other identifier: 2020P001099
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Placenta Accreta; Blood Pressure; Hemorrhage; Hemorrhage, Postpartum

Keywords

Placenta Accreta; Non-Invasive Arterial Blood Pressure; Invasive Arterial Blood Pressure; Hemorrhage; Hemorrhage, Postpartum

Outcome Measures

Primary Outcomes (1)

• Comparing concordance between MAP from the CNAP and AIBP

  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 Outcomes (6)

• Additional Comparisons of SBP and DBP

  SBP and DBP will be measured continuously throughout the operative case, with an average case timeframe of 4-6 hours.

• Stroke Volume

  Measured throughout the operative case, with an average case timeframe of 4-6 hours.

• Systemic Vascular Resistance

  Measured throughout the operative case, with an average case timeframe of 4-6 hours.

• Cardiac Output

  Measured throughout the operative case, with an average case timeframe of 4-6 hours.

• Stroke Volume Variation

  Measured throughout the operative case, with an average case timeframe of 4-6 hours.

Study Arms (1)

Pregnant women with suspected placenta accreta

Pregnant women undergoing cesarean delivery with suspected placenta accreta spectrum.

Device: LiDCO CNAP Monitoring Equipment

Interventions

LiDCO CNAP Monitoring Equipment DEVICE

A continuous non-invasive arterial blood pressure monitor for rapidly changing hemodynamics.

Pregnant women with suspected placenta accreta

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: This study will only enroll female patients given its focus on pregnancy-related complications
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women undergoing cesarean delivery with suspected placenta accreta spectrum.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (13)

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  PMID: 23345112 BACKGROUND

• Stenglova A, Benes J. Continuous Non-Invasive Arterial Pressure Assessment during Surgery to Improve Outcome. Front Med (Lausanne). 2017 Nov 17;4:202. doi: 10.3389/fmed.2017.00202. eCollection 2017.

  PMID: 29204425 BACKGROUND

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  PMID: 29916861 BACKGROUND

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  PMID: 27195632 BACKGROUND

• Rogge DE, Nicklas JY, Schon G, Grothe O, Haas SA, Reuter DA, Saugel B. Continuous Noninvasive Arterial Pressure Monitoring in Obese Patients During Bariatric Surgery: An Evaluation of the Vascular Unloading Technique (Clearsight system). Anesth Analg. 2019 Mar;128(3):477-483. doi: 10.1213/ANE.0000000000003943.

  PMID: 30649073 BACKGROUND

• Sumiyoshi M, Maeda T, Miyazaki E, Hotta N, Sato H, Hamaguchi E, Kanazawa H, Ohnishi Y, Kamei M. Accuracy of the ClearSight system in patients undergoing abdominal aortic aneurysm surgery. J Anesth. 2019 Jun;33(3):364-371. doi: 10.1007/s00540-019-02632-6. Epub 2019 Mar 23.

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• Meidert AS, Nold JS, Hornung R, Paulus AC, Zwissler B, Czerner S. The impact of continuous non-invasive arterial blood pressure monitoring on blood pressure stability during general anaesthesia in orthopaedic patients: A randomised trial. Eur J Anaesthesiol. 2017 Nov;34(11):716-722. doi: 10.1097/EJA.0000000000000690.

  PMID: 28922340 BACKGROUND

• Cecconi M, Monge Garcia MI, Gracia Romero M, Mellinghoff J, Caliandro F, Grounds RM, Rhodes A. The use of pulse pressure variation and stroke volume variation in spontaneously breathing patients to assess dynamic arterial elastance and to predict arterial pressure response to fluid administration. Anesth Analg. 2015 Jan;120(1):76-84. doi: 10.1213/ANE.0000000000000442.

  PMID: 25230102 BACKGROUND

• Hohn A, Defosse JM, Becker S, Steffen C, Wappler F, Sakka SG. Non-invasive continuous arterial pressure monitoring with Nexfin does not sufficiently replace invasive measurements in critically ill patients. Br J Anaesth. 2013 Aug;111(2):178-84. doi: 10.1093/bja/aet023. Epub 2013 Mar 13.

  PMID: 23485882 BACKGROUND

• Gupta D, Soskin V, Marjanovic M, Amhaz H, Mazumdar A. CONTINUOUS NON-INVASIVE ARTERIAL PRESSURE DEVICE AS AN ADJUNCT TO RECOGNIZE FLUCTUATING BLOOD PRESSURES DURING ELECTIVE CESAREAN SECTION UNDER SUBARACHNOID BLOCKADE (SAB). Middle East J Anaesthesiol. 2016 Feb;23(4):385-400.

  PMID: 27382807 BACKGROUND

MeSH Terms

Conditions

Placenta Accreta; Hemorrhage; Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Puerperal Disorders; Uterine Hemorrhage

Study Officials

• John J. Kowalczyk, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesia

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 17, 2020
• Study Start: January 15, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)