Comparing blood pressure monitoring methods in pregnant women with placenta accreta
Comparison of Continuous Non-Invasive Arterial Blood Pressure to Invasive Arterial Blood Pressure Measurement in Pregnant Women With Placenta Accreta
This study is testing if a new, non-invasive way to monitor blood pressure is just as good as the traditional method for pregnant women having a cesarean delivery with suspected placenta accreta.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04671680 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of continuous non-invasive arterial blood pressure (CNAP) monitoring compared to invasive arterial blood pressure (IABP) in pregnant women undergoing cesarean delivery with suspected placenta accreta. The study will involve monitoring blood pressure readings at various points during the procedure to assess concordance between the two methods. Additionally, the feasibility of using CNAP to inform clinical decisions regarding volume responsiveness and arterial elastance will be examined. Participants will undergo standard pre-operative evaluations and receive both monitoring techniques during surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-40 with pregnancies complicated by placenta accreta who are scheduled for elective cesarean delivery.
Not a fit: Patients who may not benefit from this study include those under 18, those with cardiac arrhythmias, or those requiring emergent surgical intervention.
Why it matters
Potential benefit: If successful, this study could provide a safer, non-invasive method for monitoring blood pressure in high-risk pregnant women, potentially reducing complications during cesarean deliveries.
How similar studies have performed: While the approach of using CNAP is gaining interest, this specific comparison with IABP in the context of placenta accreta is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: John J. Kowalczyk, MD — Beth Israel Deaconess Medical Center
- Study coordinator: John J. Kowalczyk, MD
- Email: jkowalcz@bidmc.harvard.edu
- Phone: (617) 667-3112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.