TERMINATED

CNAP vs IABP in Pregnant Women With Placenta Accreta

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-01-15
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04671680

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.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women aged 18-40 years old with pregnancy complicated by accreta spectrum undergoing elective, scheduled cesarean delivery and possible hysterectomy
  1. * Women aged \<18
  2. * Patients with cardiac arrhythmia
  3. * Vascular pathologies of the upper limbs (recent vascular surgery, Reynaud's disease, vascular stenosis)
  4. * Contraindication to neuraxial anesthesia
  5. * Emergent cases
  6. * Droplet or airborne precautions (as determined by BIDMC infection control policy)

Contacts and Locations

Principal Investigator

John J. Kowalczyk, MD
PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

  • John J. Kowalczyk, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

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 Registration Dates

Study Start Date2021-01-15
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2021-01-15
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Placenta Accreta
  • Blood Pressure
  • Hemorrhage
  • Hemorrhage, Postpartum