Placenta AccretaNCT04671680
CNAP vs IABP in Pregnant Women With Placenta Accreta
An observational study of Placenta Accreta and Blood Pressure, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta, Blood Pressure, Hemorrhage
- What is being tested?
- LiDCO CNAP Monitoring Equipment
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women undergoing cesarean delivery with suspected placenta accreta spectrum.
Who may be able to join
- Women aged 18-40 years old with pregnancy complicated by accreta spectrum undergoing elective, scheduled cesarean delivery and possible hysterectomy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: 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
Read more
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.
Read the 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.
- Conditions
- Placenta Accreta, Blood Pressure, Hemorrhage, Hemorrhage, Postpartum
- Being tested
- LiDCO CNAP Monitoring Equipment
- Keywords
- Placenta Accreta, Non-Invasive Arterial Blood Pressure, Invasive Arterial Blood Pressure, Hemorrhage, Hemorrhage, Postpartum
- Medical subject headings
- Placenta Accreta, Hemorrhage, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiDCO CNAP Monitoring EquipmentDevice
A continuous non-invasive arterial blood pressure monitor for rapidly changing hemodynamics.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with suspected placenta accreta | Pregnant women undergoing cesarean delivery with suspected placenta accreta spectrum. Receives: Device: LiDCO CNAP Monitoring Equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: SBP and DBP will be measured continuously throughout the operative case, with an average case timeframe of 4-6 hours.
Stroke Volume
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: Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Systemic Vascular Resistance
Review of extrapolated data outputs to assess changes in the arterioles.
Measured: Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Cardiac Output
Review of extrapolated data outputs to assess heart rate product.
Measured: Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Stroke Volume Variation
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: Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Subgroup analysis of CNAP and AIBP
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: Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start15 Jan 2021
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Why it stopped: Unable to obtain data from device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip Hess, Beth Israel Deaconess Medical Center
- Investigators
- John J. Kowalczyk, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671680
- Sponsor's protocol ID
- 2020P001099
- Status last verified
- Oct 2025
- First submitted
- 30 Nov 2020
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hamilton BE, Martin JA, Osterman MJ, Curtin SC, Matthews TJ. Births: Final Data for 2014. Natl Vital Stat Rep. 2015 Dec;64(12):1-64.
PubMed 26727629Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related mortality in the United States, 2006-2010. Obstet Gynecol. 2015 Jan;125(1):5-12. doi: 10.1097/AOG.0000000000000564.
PubMed 25560097Creanga AA, Berg CJ, Ko JY, Farr SL, Tong VT, Bruce FC, Callaghan WM. Maternal mortality and morbidity in the United States: where are we now? J Womens Health (Larchmt). 2014 Jan;23(1):3-9. doi: 10.1089/jwh.2013.4617.
PubMed 24383493Chung E, Chen G, Alexander B, Cannesson M. Non-invasive continuous blood pressure monitoring: a review of current applications. Front Med. 2013 Mar;7(1):91-101. doi: 10.1007/s11684-013-0239-5. Epub 2013 Jan 23.
PubMed 23345112Stenglova 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.
PubMed 29204425Maheshwari K, Khanna S, Bajracharya GR, Makarova N, Riter Q, Raza S, Cywinski JB, Argalious M, Kurz A, Sessler DI. A Randomized Trial of Continuous Noninvasive Blood Pressure Monitoring During Noncardiac Surgery. Anesth Analg. 2018 Aug;127(2):424-431. doi: 10.1213/ANE.0000000000003482.
PubMed 29916861Bartels K, Esper SA, Thiele RH. Blood Pressure Monitoring for the Anesthesiologist: A Practical Review. Anesth Analg. 2016 Jun;122(6):1866-79. doi: 10.1213/ANE.0000000000001340.
PubMed 27195632Rogge 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.
PubMed 30649073Sumiyoshi 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.
PubMed 30904953Meidert 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.
PubMed 28922340Cecconi 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.
PubMed 25230102Hohn 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.
PubMed 23485882Gupta 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.
PubMed 27382807
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Continuous Non-Invasive Arterial Blood Pressure to Invasive Arterial Blood Pressure Measurement in Pregnant Women With Placenta Accreta
- ClinicalTrials.gov ID
- NCT04671680
- Acronym / sponsor ID
- 2020P001099
- Conditions
- Placenta Accreta, Blood Pressure, Hemorrhage, Hemorrhage, Postpartum
- Keywords
- Placenta Accreta, Non-Invasive Arterial Blood Pressure, Invasive Arterial Blood Pressure, Hemorrhage, Hemorrhage, Postpartum
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to obtain data from device
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with suspected placenta accreta | – | Device: LiDCO CNAP Monitoring EquipmentPregnant women undergoing cesarean delivery with suspected placenta accreta spectrum. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women undergoing cesarean delivery with suspected placenta accreta spectrum.
Key inclusion criteria (1 listed)
- Women aged 18-40 years old with pregnancy complicated by accreta spectrum undergoing elective, scheduled cesarean delivery and possible hysterectomy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiDCO CNAP Monitoring EquipmentA continuous non-invasive arterial blood pressure monitor for rapidly changing hemodynamics. | Device | Pregnant women with suspected placenta accreta |
Primary outcome
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.
6 secondary outcomes
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.
Stroke Volume
Time frame: 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.
Cardiac Output
Time frame: 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.
Subgroup analysis of CNAP and AIBP
Time frame: Measured throughout the operative case, with an average case timeframe of 4-6 hours.
Results and safety
The study was stopped early (reason given: Unable to obtain data from device). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Background: PubMed 26727629Hamilton BE, Martin JA, Osterman MJ, Curtin SC, Matthews TJ. Births: Final Data for 2014. Natl Vital Stat Rep. 2015 Dec;64(12):1-64.
- Background: PubMed 25560097Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related mortality in the United States, 2006-2010. Obstet Gynecol. 2015 Jan;125(1):5-12. doi: 10.1097/AOG.0000000000000564.
- Background: PubMed 24383493Creanga AA, Berg CJ, Ko JY, Farr SL, Tong VT, Bruce FC, Callaghan WM. Maternal mortality and morbidity in the United States: where are we now? J Womens Health (Larchmt). 2014 Jan;23(1):3-9. doi: 10.1089/jwh.2013.4617.
- Background: PubMed 23345112Chung E, Chen G, Alexander B, Cannesson M. Non-invasive continuous blood pressure monitoring: a review of current applications. Front Med. 2013 Mar;7(1):91-101. doi: 10.1007/s11684-013-0239-5. Epub 2013 Jan 23.
- Background: PubMed 29204425Stenglova 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.
- Background: PubMed 29916861Maheshwari K, Khanna S, Bajracharya GR, Makarova N, Riter Q, Raza S, Cywinski JB, Argalious M, Kurz A, Sessler DI. A Randomized Trial of Continuous Noninvasive Blood Pressure Monitoring During Noncardiac Surgery. Anesth Analg. 2018 Aug;127(2):424-431. doi: 10.1213/ANE.0000000000003482.
- Background: PubMed 27195632Bartels K, Esper SA, Thiele RH. Blood Pressure Monitoring for the Anesthesiologist: A Practical Review. Anesth Analg. 2016 Jun;122(6):1866-79. doi: 10.1213/ANE.0000000000001340.
- Background: PubMed 30649073Rogge 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.
- Background: PubMed 30904953Sumiyoshi 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.
- Background: PubMed 28922340Meidert 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.
- Background: PubMed 25230102Cecconi 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.
- Background: PubMed 23485882Hohn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J. Kowalczyk, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta and Blood Pressure, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to obtain data from device). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04671680, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.