Placenta Accreta SpectrumNCT06493968
Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With PASD Undergoing Cesarean Hysterectomy
A study testing oxytocin in people with Placenta Accreta Spectrum, run by Cairo University at 1 site in Egypt.
Trial summary
Objectives: To evaluate the effect of oxytocin in reducing intraoperative blood loss in patients with PAS disorders planned for cesarean hysterectomy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta Spectrum
- What is being tested?
- oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 31 Dec 2024
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnancy of singleton living fetus
- Previous one or more cesarean sections
- Gestational age: > 32 weeks
- The following ultrasound markers such as "loss of clear retroplacental translucency", "myometrial thinning", "abnormal lacunae", "irregular bladder wall", "utero-vesicalhypervascularity".
- Preoperative hemoglobin more than 10 gm/dl
- Cases with PAS that will undergoing CS Hysterectomy
Who cannot join
- Maternal medical disorders e.g.: coagulation defects, cardiac diseases etc.….
- Any known or reported hypersensitivity to the used medication.
- All cases with spontaneous placental separation at laparotomy.
- All patients undergoing conservative management of PAS.
- All cases which necessitate emergency termination.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Abdalla Mousa, +201277664430, Dr_abdallamousa@yahoo.com
About this study
Official title: Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With Placenta Accrete Spectrum Disorders Undergoing Cesarean Hysterectomy
Objectives: To evaluate the effect of oxytocin in reducing intraoperative blood loss in patients with PAS disorders planned for cesarean hysterectomy.
- Conditions
- Placenta Accreta Spectrum
- Being tested
- oxytocin, placebo
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocinDrug
Uterotonics will be given in the form of an IV bolus of 10 units of oxytocin immediately with the uterine incision
placeboOther
IV bolus of normal saline immediately with the uterine incision
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | Patients will be given uterotonics Receives: Drug: oxytocin |
| Group (B) | Placebo comparator | Patients will not be given uterotonics Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
amount of intraoperative blood loss in patients with PAS disorders undergoing cesarean hysterectomy
Measured: during operation
Secondary outcomes (1)
operative time
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Jul 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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.
- More trials run by Cairo UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdalla Mousa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493968
- Sponsor's protocol ID
- Uterotonics in PASD
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With Placenta Accrete Spectrum Disorders Undergoing Cesarean Hysterectomy
- ClinicalTrials.gov ID
- NCT06493968
- Acronym / sponsor ID
- Uterotonics in PASD
- Conditions
- Placenta Accreta Spectrum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Jul 2024 (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.
Objectives: To evaluate the effect of oxytocin in reducing intraoperative blood loss in patients with PAS disorders planned for cesarean hysterectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Drug: oxytocinPatients will be given uterotonics |
| Group (B) | Placebo comparator | Other: placeboPatients will not be given uterotonics |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnancy of singleton living fetus
- Previous one or more cesarean sections
- Gestational age: > 32 weeks
- The following ultrasound markers such as "loss of clear retroplacental translucency", "myometrial thinning", "abnormal lacunae", "irregular bladder wall", "utero-vesicalhypervascularity".
- Preoperative hemoglobin more than 10 gm/dl
Key exclusion criteria (5 listed)
- Maternal medical disorders e.g.: coagulation defects, cardiac diseases etc.….
- Any known or reported hypersensitivity to the used medication.
- All cases with spontaneous placental separation at laparotomy.
- All patients undergoing conservative management of PAS.
- All cases which necessitate emergency termination.
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 |
|---|---|---|
| oxytocinUterotonics will be given in the form of an IV bolus of 10 units of oxytocin immediately with the uterine incision | Drug | Group (A) |
| placeboIV bolus of normal saline immediately with the uterine incision | Other | Group (B) |
Primary outcome
Intraoperative blood loss
Time frame: during operation
amount of intraoperative blood loss in patients with PAS disorders undergoing cesarean hysterectomy
1 secondary outcome
operative time
Time frame: during operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxytocin in people with Placenta Accreta Spectrum, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdalla Mousa (+201277664430, Dr_abdallamousa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: during operation). 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 10 Jul 2024.