Placenta Accreta SpectrumNCT04927988
Blood Components Changes by Using of Ringer's Lactated as Detergent In Autologous Blood Cell Transfusion
A study testing Ringer's Lactated in people with Placenta Accreta Spectrum, run by Maternal and Child Health Hospital of Foshan at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placenta Accreta Spectrum
- What is being tested?
- Ringer's Lactated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Oct 2021to Dec 2022
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Between 18 and 45 years old
- Without health problem nor disease requiring regular medical treatment
Who cannot join
- subject with contraindication for drawing blood
- Subject with physical or mental disability or restriction of liberty that would prevent autotransfusion
Trial locations and contacts
1 site in 1 country.
China1 site
Maternal and Child Health Hospital of Foshan
Foshan, Guangdong, 528000
About this study
Official title: Blood Components Changes by Using of Ringer's Lactated as Detergent In Autologous Blood Cell Transfusion: A Prospective, Single-center, Open, and Single-arm Clinical Trial
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.
- Conditions
- Placenta Accreta Spectrum
- Being tested
- Ringer's Lactated
- Keywords
- Placenta Accreta Spectrum, Autologous Blood Cell Transfusion, Blood Components
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's LactatedOther
Using of Ringer's Lactated In Autologous Blood Cell Transfusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1. | Other | Using of Ringer's Lactated Receives: Other: Ringer's Lactated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hematological parameters
erythrocytes (/µL)
Measured: Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters
hemoglobin (g/dL)
Measured: Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters
Mean corpuscular volume (fL)
Measured: Baseline (Day 1), until 2 days after autotransfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study startOct 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: halted by the pandemic of COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta SpectrumStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maternal and Child Health Hospital of Foshan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927988
- Sponsor's protocol ID
- MCHHFoshan-2101
- Status last verified
- Apr 2023
- First submitted
- 9 Jun 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Components Changes by Using of Ringer's Lactated as Detergent In Autologous Blood Cell Transfusion: A Prospective, Single-center, Open, and Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT04927988
- Acronym / sponsor ID
- MCHHFoshan-2101
- Conditions
- Placenta Accreta Spectrum
- Keywords
- Placenta Accreta Spectrum, Autologous Blood Cell Transfusion, Blood Components
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: halted by the pandemic of COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maternal and Child Health Hospital of FoshanUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Jun 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1. | Other | Other: Ringer's LactatedUsing of Ringer's Lactated |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between 18 and 45 years old
- Without health problem nor disease requiring regular medical treatment
Key exclusion criteria (2 listed)
- subject with contraindication for drawing blood
- Subject with physical or mental disability or restriction of liberty that would prevent autotransfusion
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 |
|---|---|---|
| Ringer's LactatedUsing of Ringer's Lactated In Autologous Blood Cell Transfusion | Other | Arm 1. |
Primary outcome
Change in hematological parameters
Time frame: Baseline (Day 1), until 2 days after autotransfusion
erythrocytes (/µL)
Change in hematological parameters
Time frame: Baseline (Day 1), until 2 days after autotransfusion
hemoglobin (g/dL)
Change in hematological parameters
Time frame: Baseline (Day 1), until 2 days after autotransfusion
Mean corpuscular volume (fL)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ringer's Lactated in people with Placenta Accreta Spectrum, run by Maternal and Child Health Hospital of Foshan at 1 site in China.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 25 Apr 2023. 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 China. 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 withdrawn before enrolling participants, so there are no results.
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?
Change in hematological parameters (time frame: Baseline (Day 1), until 2 days after autotransfusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2023; AzTrials last refreshed its copy on 30 Oct 2026.