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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04927988
Other study ID # MCHHFoshan-2101
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2021
Est. completion date December 2022

Study information

Verified date April 2023
Source Maternal and Child Health Hospital of Foshan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Placenta accreta spectrum (PAS) disorders are associated with increased maternal morbidity and mortality related to life-threatening hemorrhage, and greater potential need for blood transfusion. Clinical evidences have confirmed that the use of autologous blood cell transfusion is safe and effective for patients with obstetric haemorrhage. Normal saline is the solution recommended for red cell washing, administration and salvage. However, there is growing concern that normal saline is more toxic than balanced, buffered crystalloids such as Lactated Ringer's and Plasma-Lyte. The purpose of this study is to evaluate the blood components using of Ringer's Lactated by a prospective, single-center, open, and single-arm clinical trial.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2022
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Between 18 and 45 years old - Without health problem nor disease requiring regular medical treatment Exclusion Criteria: - subject with contraindication for drawing blood - Subject with physical or mental disability or restriction of liberty that would prevent autotransfusion

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Ringer's Lactated
Using of Ringer's Lactated In Autologous Blood Cell Transfusion

Locations

Country Name City State
China Maternal and Child Health Hospital of Foshan Foshan Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Maternal and Child Health Hospital of Foshan

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in hematological parameters erythrocytes (/µL) Baseline (Day 1), until 2 days after autotransfusion
Primary Change in hematological parameters hemoglobin (g/dL) Baseline (Day 1), until 2 days after autotransfusion
Primary Change in hematological parameters Mean corpuscular volume (fL) Baseline (Day 1), until 2 days after autotransfusion
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04525001 - MOGGE PAR Scores for Prediction of Outcomes of PAS
Completed NCT04427592 - New Conservative Technique for Placenta Accreta Spectrum N/A
Completed NCT04314791 - Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum
Completed NCT06356493 - Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for PASD
Recruiting NCT06383923 - Risk Factors, Prognosis and Prediction Models for Placenta Accreta Without Prior Cesarean Section
Recruiting NCT05752513 - Early vs Late Bladder Dissection During CS Hysterectomy in Patients With PAS With Bladder Invasion N/A
Not yet recruiting NCT04229953 - Accuracy of Three /Four-dimensional Ultrasound in Diagnosing Placenta Accreta Spectrum
Completed NCT05500404 - Diagnostic Accuracy of Placental Thickness in Lower Uterine Segment Measured By Ultrasound in Prediction of Placenta Accreta Spectrum in Patients With Placenta Previa. A Diagnostic Test Accuracy Study
Recruiting NCT05510076 - Evaluation of Different Surgical Approaches Used for Conservative Management of Placenta Accreta Spectrum in Sohag University Hospital
Not yet recruiting NCT05481606 - Cesarean Scar Pregnancy and Clinical Outcomes
Recruiting NCT04866888 - Placenta Accreta Spectrum Outcome After Uterine Conservation N/A