Complications; Cesarean SectionPhase 3NCT01412073
Control of Blood Loss During Caesarean Section
A Phase 3 study testing oxytocin and Misoprostol in people with Complications; Cesarean Section, run by Cairo University at 1 site in Egypt.
Trial summary
trial of 3 protocols to determine the best one to control blood loss during caesarean section Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complications; Cesarean Section
- What is being tested?
- oxytocin and Misoprostol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2011to Oct 2014
- Phase
- Phase 3
- 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 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients booked for elective cesarean section.
- Singleton pregnancies.
- Primigravida or multipara ,first cesarean section or previous .
Who cannot join
- Patients with obstetric hemorrhage.
- Uterine laceration.
- Placenta previa.
- Blood dyscrasias.
- Large fibroids.
- Multiple pregnancy.
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- Pre-eclampsia.
- Marked maternal anemia.
- Previous history of PPH.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of medicine , Cairo University
Cairo, Cairo Governorate, 12211
About this study
Official title: A Randomized Trial to Determine the Best Strategy for the Control of Blood Loss at Elective Caesarean Section
trial of 3 protocols to determine the best one to control blood loss during caesarean section
Read the detailed description
The study population will be divided into 3 groups each containing 200 women:
Group (A): 200 patients will receive 5-IU oxytocin bolus over 3 minutes after delivery of the baby.
Group (B): 200 patients will receive 5-IU oxytocin bolus over 3 minutes and 30-IU oxytocin infusion in 500 ml 0.9 % saline over 4 hours after delivery of the baby.
Group (C): 200 patients will receive misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity.
Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward.
Hemoglobin level and haematocrit value will be done as follow:-
- After admission of each case in the pre-operative period.
- Immediately post- operative.
- 24 hours post- operative.
- Conditions
- Complications; Cesarean Section
- Being tested
- oxytocin, Misoprostol
- Keywords
- caesarean section, intrapartum haemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocinDrug
Also called syntocinon
group I : oxytocin 5 IU bolus over 3 minutes after delivery of the baby group II : oxytocin 5 IU bolus over 3 minutes after delivery of the baby and oxytocin infusion in 500 ml 0.9% saline over 4 hours
MisoprostolDrug
Also called cytotec
misoprostol intrauterine 800 microgram placed intrauterine after delivery of the baby \& the placenta
| Study group | Role | What they receive |
|---|---|---|
| oxytocin bolus | Active comparator | 5 IU bolus iv over 3 minutes after delivery of the baby Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward.
Hemoglobin level and haematocrit value will be done as follow:-
1. After admission of each case in the pre-operative period.
2. Immediately post- operative.
3. 24 hours post- operative. Receives: Drug: oxytocin |
| oxytocin bolus & oxytocin infusion | Active comparator | 5 IU oxytoxin bolus over 3 minutes and 30 IU oxytocin infusion in 500 ml 0.9% saline over 4 hours after delivery of the baby Receives: Drug: oxytocin |
| misoprostol intrauterine | Active comparator | misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of blood loss
Measured: 12 month
Secondary outcomes (1)
Haemoglobin % and haematocrit value
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Cesarean SectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed El-khayat, Cairo University
- Investigators
- Waleed M El-khayat, M.D., Study director, Lecturer of Obstetrics & Gynecology , Faculty of medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412073
- Sponsor's protocol ID
- 582011
- Status last verified
- Oct 2014
- First submitted
- 5 Aug 2011
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Determine the Best Strategy for the Control of Blood Loss at Elective Caesarean Section
- ClinicalTrials.gov ID
- NCT01412073
- Acronym / sponsor ID
- 582011
- Conditions
- Complications; Cesarean Section
- Keywords
- caesarean section, intrapartum haemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Aug 2011 (estimated)
- 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.
trial of 3 protocols to determine the best one to control blood loss during caesarean section
Detailed description
The study population will be divided into 3 groups each containing 200 women:
Group (A): 200 patients will receive 5-IU oxytocin bolus over 3 minutes after delivery of the baby.
Group (B): 200 patients will receive 5-IU oxytocin bolus over 3 minutes and 30-IU oxytocin infusion in 500 ml 0.9 % saline over 4 hours after delivery of the baby.
Group (C): 200 patients will receive misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity.
Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward.
Hemoglobin level and haematocrit value will be done as follow:-
- After admission of each case in the pre-operative period.
- Immediately post- operative.
- 24 hours post- operative.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| oxytocin bolus | Active comparator | Drug: oxytocin5 IU bolus iv over 3 minutes after delivery of the baby Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward. Hemoglobin level and haematocrit value will be done as follow:- 1. After admission of each case in the pre-operative period. 2. Immediately post- operative. 3. 24 hours post- operative. |
| oxytocin bolus & oxytocin infusion | Active comparator | Drug: oxytocin5 IU oxytoxin bolus over 3 minutes and 30 IU oxytocin infusion in 500 ml 0.9% saline over 4 hours after delivery of the baby |
| misoprostol intrauterine | Active comparator | Drug: Misoprostolmisoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients booked for elective cesarean section.
- Singleton pregnancies.
- Primigravida or multipara ,first cesarean section or previous .
Key exclusion criteria (9 listed)
- Patients with obstetric hemorrhage.
- Uterine laceration.
- Placenta previa.
- Blood dyscrasias.
- Large fibroids.
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 |
|---|---|---|
| oxytocinAlso: syntocinongroup I : oxytocin 5 IU bolus over 3 minutes after delivery of the baby group II : oxytocin 5 IU bolus over 3 minutes after delivery of the baby and oxytocin infusion in 500 ml 0.9% saline over 4 hours | Drug | oxytocin bolus, oxytocin bolus & oxytocin infusion |
| MisoprostolAlso: cytotecmisoprostol intrauterine 800 microgram placed intrauterine after delivery of the baby \& the placenta | Drug | misoprostol intrauterine |
Primary outcome
amount of blood loss
Time frame: 12 month
1 secondary outcome
Haemoglobin % and haematocrit value
Time frame: 12 month
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 7 Oct 2014.
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Waleed M El-khayat, M.D. study director
Lecturer of Obstetrics & Gynecology , Faculty of medicine, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oxytocin and Misoprostol in people with Complications; Cesarean Section, 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 3 inclusion and 9 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 7 Oct 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
amount of blood loss (time frame: 12 month). 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 7 Oct 2014.