Postpartum HemorrhagePhase 4NCT03344302
Oxytocin Administration During Cesarean Section
A Phase 4 study testing Oxytocin in people with Postpartum Hemorrhage, run by Assiut University at 1 site in Egypt.
Trial summary
Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the uterine wall. This definition does not include removal of the fetus from the abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy The guidelines of the Royal College of Obstetricians and… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postpartum 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
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2016to Sep 2017
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Primigravida or multigravida
- Term (37 - 42 weeks),
- Singleton pregnancies
- Booked for elective caesarean section.
- Accepting to participate in the study.
Who cannot join
- • Medical disorders involving the heart, liver, kidney or brain.
- Diabetes mellitus and hypertension.
- Blood disorders (e.g. coagulopathies, thrombocytopenia)
- Patients requiring blood transfusion due to anemia.
- Risk factors for uterine atony e.g. macrosomia, polyhydramnios and multiple pregnancy.
- Previous 2 or more cesarean section
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- Placenta previa or placental abruption
- Previous major obstetric haemorrhage (>1000 ml) in previous deliveries.
- Known fibroid or adenomyosis.
- Women who received anticoagulant therapy.
- Severe preeclampsis.
- Uterine anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxytocin Administration During Cesarean Section Before Versus After Fetal Delivery Randomized Clinical Trial
Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the uterine wall. This definition does not include removal of the fetus from the abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy The guidelines of the Royal College of Obstetricians and Gynaecologists on caesarean section recommend a slow intravenous bolus dose of 5 IU of oxytocin after delivery of the infant. Intravenous oxytocin has a short half life (4-10 minutes); therefore the potential advantage of an oxytocin infusion at caesarean section is in maintaining uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhage occurs
- Conditions
- Postpartum 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
intravenous infusion of oxytocin 30 units over 5 minutes diluted into 500 mL of normal 0.9% sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | 100 women were assigned to receive an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour minutes diluted into 500 mL of normal 0.9% sodium chloride) immediately after opening the visceral peritoneum just before incising the uterine wall during Cesarean section Receives: Drug: Oxytocin |
| Control group | Active comparator | 100 women were assigned to an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour diluted into 500 mL of normal 0.9% sodium chloride) immediately after clamping the umbilical cord during cesarean section Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of blood loss
collection of the blood in the drape below the patient
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study startOct 2016
- Primary completionAug 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344302
- Sponsor's protocol ID
- OACS
- Status last verified
- Apr 2018
- First submitted
- 13 Nov 2017
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin Administration During Cesarean Section Before Versus After Fetal Delivery Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03344302
- Acronym / sponsor ID
- OACS
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 17 Nov 2017 (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.
Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the uterine wall. This definition does not include removal of the fetus from the abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy The guidelines of the Royal College of Obstetricians and Gynaecologists on caesarean section recommend a slow intravenous bolus dose of 5 IU of oxytocin after delivery of the infant. Intravenous oxytocin has a short half life (4-10 minutes); therefore the potential advantage of an oxytocin infusion at caesarean section is in maintaining uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhage occurs
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Oxytocin100 women were assigned to receive an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour minutes diluted into 500 mL of normal 0.9% sodium chloride) immediately after opening the visceral peritoneum just before incising the uterine wall during Cesarean section |
| Control group | Active comparator | Drug: Oxytocin100 women were assigned to an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour diluted into 500 mL of normal 0.9% sodium chloride) immediately after clamping the umbilical cord during cesarean section |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primigravida or multigravida
- Term (37 - 42 weeks),
- Singleton pregnancies
- Booked for elective caesarean section.
- Accepting to participate in the study.
Key exclusion criteria (12 listed)
- • Medical disorders involving the heart, liver, kidney or brain.
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 |
|---|---|---|
| Oxytocinintravenous infusion of oxytocin 30 units over 5 minutes diluted into 500 mL of normal 0.9% sodium chloride | Drug | Control group, study group |
Primary outcome
rate of blood loss
Time frame: 4 hours
collection of the blood in the drape below the patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- 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 Phase 4 study testing Oxytocin in people with Postpartum Hemorrhage, run by Assiut 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 23 Apr 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
rate of blood loss (time frame: 4 hours). 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 23 Apr 2018.