Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03046784
Other study ID # darnord2017-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date May 31, 2017

Study information

Verified date April 2020
Source Hospital Nord
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This prospective and observational trial over 55 pregnant women (third trimester) compares non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date May 31, 2017
Est. primary completion date March 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- third trimester of pregnancy

- Non-labouring pregnant women

- accepting study

Exclusion Criteria:

- refusal of study

- first or second trimester of pregnancy

Study Design


Intervention

Other:
haemodynamic evaluation
continous haemodynamic monitoring is performed with digital Nexfin captor in two positions. in the same time transthoracic cardiac ultrasonography is performed to calculate cardiac output using velocity time index of aortic outflow chamber.

Locations

Country Name City State
France Departement anesthesie reanimation hopital nord Marseille

Sponsors (1)

Lead Sponsor Collaborator
Hospital Nord

Country where clinical trial is conducted

France, 

References & Publications (2)

Lee SW, Khaw KS, Ngan Kee WD, Leung TY, Critchley LA. Haemodynamic effects from aortocaval compression at different angles of lateral tilt in non-labouring term pregnant women. Br J Anaesth. 2012 Dec;109(6):950-6. doi: 10.1093/bja/aes349. Epub 2012 Oct 11. — View Citation

Montenij LJ, Buhre WF, Jansen JR, Kruitwagen CL, de Waal EE. Methodology of method comparison studies evaluating the validity of cardiac output monitors: a stepwise approach and checklist. Br J Anaesth. 2016 Jun;116(6):750-8. doi: 10.1093/bja/aew094. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac output measure Cardiac output is measured with non-invasive digital Nexfin technology (ml/min) and compared with transthoracic echocardiographic measure of cardiac output (ml/min) used as reference.
Echographic cardiac output (ml/min) is measured as the produce of cross sectional aera of left ventricular outflow track (cm²) multiplied by velocity time index (cm) multiplied by heart rate (beat/min)
30 minutes
See also
  Status Clinical Trial Phase
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Completed NCT03284515 - Vaccination In Pregnancy Gene Signature: VIP Signature Study
Recruiting NCT05969795 - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support Phase 1
Recruiting NCT06051201 - Innovation for Small-scale Experiments: ReceptIVFity Test N/A
Recruiting NCT04828382 - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Recruiting NCT04278651 - Early Antenatal Support for Iron Deficiency Anemia Phase 4
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting NCT06258902 - Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Completed NCT05487196 - Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia Phase 2
Completed NCT03750968 - Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects Phase 2
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Completed NCT05897697 - Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Recruiting NCT05899101 - The Impact of Opioid and Cannabis Exposure on Fetal Growth
Completed NCT05502510 - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Completed NCT04296396 - Opioid Prescription After Cesarean Trial Phase 3
Not yet recruiting NCT06069869 - Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06069856 - Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06079918 - Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania Phase 3
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A