Post Partum HemorrhageNCT06560099
Standard Oxytocin Versus High Dose Oxytocin to Control Postpartum Hemorrhage in High Risk Pregnancy During Elective Cesarean Section
A study testing Oxytocin in people with Post Partum Hemorrhage, run by Ain Shams University.
Trial summary
Controlling hemorrhage during and after a cesarean section reduces significantly maternal mortality and morbidity and the present study is important for detection of the effectiveness of routinely increasing the oxytocin dose instead of using the standard dose only in preventing postpartum hemorrhage and additional… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2024to 25 Apr 2025
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Medical disorders ie: Hypertensive diseases with pregnancy - Diabetes Mellitus - Collagen diseases - Coagulopathies - Cardiac diseases - Anemia
- History of postpartum hemorrhage
- Placental disorders ie: placenta previa
- Infertility and ICSI
- High Parity
- History of Endometriosis
Show all 11Show fewer
- Fetal disorders (IUGR, IUFD, Preterm, Congenital anomalies, oligohydramnios or polyhydramnios, macrosomia)
- Preterm labor on uterine relaxants
- Twins pregnancy
- Patients on antiplatelets and anticoagulants
- Uneventful antenatal care
Who cannot join
- - Oxytocin Allergy
- Normal uncomplicated pregnancy
- Emergency cesarean section
- Exhausted uterus due to trial of normal labor
- Couvelaire uterus
About this study
Controlling hemorrhage during and after a cesarean section reduces significantly maternal mortality and morbidity and the present study is important for detection of the effectiveness of routinely increasing the oxytocin dose instead of using the standard dose only in preventing postpartum hemorrhage and additional use of uterotonics in the first 24 hours after cesarean section for high risk pregnancy.
- Conditions
- Post Partum Hemorrhage
- Being tested
- Oxytocin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
will receive 10 IU oxytocin intravenous bolus over one min and infusion of 10 IU oxytocin in 500 ml of 0.9 saline over four hours.
| Study group | Role | What they receive |
|---|---|---|
| Group A (standard oxytocin dose) | Active comparator | Not described Receives: Drug: Oxytocin |
| Group B (high dose oxytocin) | Active comparator | Not described Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
measure blood in suction, towels and pads
Measured: at the end of the operation
Secondary outcomes (2)
haemoglobin
by laboratory asessment
Measured: immediate preoperative
haemoglobin
by laboratory asessment
Measured: 6 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start25 Aug 2024 (estimated)
- Primary completion25 Apr 2025 (estimated)
- Study completion25 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560099
- Sponsor's protocol ID
- Laura 1 protocol
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Oxytocin Versus High Dose Oxytocin to Control Postpartum Hemorrhage in High Risk Pregnancy During Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT06560099
- Acronym / sponsor ID
- Laura 1 protocol
- Conditions
- Post Partum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Aug 2024 (estimated)
- Primary completion
- 25 Apr 2025 (estimated)
- Study completion
- 25 Apr 2025 (estimated)
- First posted
- 19 Aug 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.
Controlling hemorrhage during and after a cesarean section reduces significantly maternal mortality and morbidity and the present study is important for detection of the effectiveness of routinely increasing the oxytocin dose instead of using the standard dose only in preventing postpartum hemorrhage and additional use of uterotonics in the first 24 hours after cesarean section for high risk pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (standard oxytocin dose) | Active comparator | Drug: Oxytocin |
| Group B (high dose oxytocin) | Active comparator | Drug: Oxytocin |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- - Medical disorders ie: Hypertensive diseases with pregnancy - Diabetes Mellitus - Collagen diseases - Coagulopathies - Cardiac diseases - Anemia
- History of postpartum hemorrhage
- Placental disorders ie: placenta previa
- Infertility and ICSI
- High Parity
Key exclusion criteria (5 listed)
- - Oxytocin Allergy
- Normal uncomplicated pregnancy
- Emergency cesarean section
- Exhausted uterus due to trial of normal labor
- Couvelaire uterus
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 |
|---|---|---|
| Oxytocinwill receive 10 IU oxytocin intravenous bolus over one min and infusion of 10 IU oxytocin in 500 ml of 0.9 saline over four hours. | Drug | Group A (standard oxytocin dose), Group B (high dose oxytocin) |
Primary outcome
blood loss
Time frame: at the end of the operation
measure blood in suction, towels and pads
2 secondary outcomes
haemoglobin
Time frame: immediate preoperative
haemoglobin
Time frame: 6 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Post Partum Hemorrhage, run by Ain Shams University.
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 11 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 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
blood loss (time frame: at the end of the 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 19 Aug 2024.