Intrapartum HemorrhageNCT03009994
Exteriorization Versus Non-exteriorization of the Uterus During Repair of Uterine Incision in a Repeated Cesarean Section
A study testing Repair of uterine incision, Exteriorization of the uterus and Non exteriorization of the uterus in people with Intrapartum Hemorrhage, run by Assiut University at 1 site in Egypt.
Trial summary
Cesarean section is one of the most frequently performed major operations worldwide. It accounts for between 1% and 70% of deliveries depending on the facilities or country assessed. In Egypt, the cesarean section rate is 22%, with higher rates seen in private hospitals. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Intrapartum Hemorrhage
- What is being tested?
- Repair of uterine incision, Exteriorization of the uterus and Non exteriorization of the uterus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,024 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2016to 1 Dec 2017
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women in 28 weeks
- Women who will undergo repeated lower segment cesarean section
Who cannot join
- First cesarean section
- Placenta previa.
- Rupture uterus.
- Classical caesarean section.(upper segment cesarean section)
- Sever Preeclampsia.
- Chorioamnionitis.
Show all 10Show fewer
- prolonged or obstructed labour.
- Fibroid.
- Polyhydramnios.
- Multiple pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Cesarean section is one of the most frequently performed major operations worldwide. It accounts for between 1% and 70% of deliveries depending on the facilities or country assessed. In Egypt, the cesarean section rate is 22%, with higher rates seen in private hospitals. In 2015 ,incidence of cesarean section rate in Woman Health Hospital in Assiut university is 51.3% of all deliveries.
Different Operational techniques For cesarean section have been defined aimed at reducing surgical time, making the surgery easier and more efficient, lowering costs,decreasing the risk of adverse effects and postoperative morbidity, as well as length of hospital stay.
Read more
Also, Intraoperative blood loss is one of important complications during cesarean section. A systematic review included twenty one studies, in 2011, revealed that increase incidence of intraoperative blood loss and blood transfusion with increase number of cesarean deliveries.also anemia in the pregnancy increase maternal morbidities included intraoperative blood loss. In Egypt, prevalence of Iron deficiency anemia among pregnant women about 51% of pregnant women.
After baby born by cesarean section and the placenta has been extracted, uterine incision is sutured either by temporary removal of the uterus from the abdominal cavity (exteriorization of the uterus) to facilitate uterine incision repair or it is repaired within the abdominal cavity (in situ repair). There had been few randomized controlled trials comparing intraoperative and postoperative morbidity following exteriorization of the uterus with non-exteriorization. The conclusions drawn from these trials have been conflicting.
- Conditions
- Intrapartum Hemorrhage
- Being tested
- Repair of uterine incision, Exteriorization of the uterus, Non exteriorization of the uterus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair of uterine incisionProcedure or surgery
Exteriorization of the uterusProcedure or surgery
Non exteriorization of the uterusProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Exteriorization group | Other | After delivery of the fetus and placenta, the surgeon bring uterus yet out from peritoneal cavity by manual handling of the uterus uterus from fundus and extracted out of the abdominal cavity before starting to close it. After repair of the uterus , uterus returned to abdominal cavity and repair anterior abdominal wall as following. Receives: Procedure: Repair of uterine incision; Procedure: Exteriorization of the uterus |
| Non exteriorization group | Other | Uterine incision will be repaired intra abdominally Receives: Procedure: Repair of uterine incision; Procedure: Non exteriorization of the uterus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss (mL)
Measured: 20 minutes
Postoperative Hemoglobin (gm/L)
Measured: 20 minutes
Secondary outcomes (1)
Duration of operation (minutes)
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start1 Sep 2016
- Primary completion1 Aug 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrapartum 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009994
- Sponsor's protocol ID
- EUR
- Status last verified
- Jul 2024
- First submitted
- 3 Jan 2017
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exteriorization Versus Non-exteriorization of the Uterus During Repair of Uterine Incision in a Repeated Cesarean Section
- ClinicalTrials.gov ID
- NCT03009994
- Acronym / sponsor ID
- EUR
- Conditions
- Intrapartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,024 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 4 Jan 2017 (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.
Cesarean section is one of the most frequently performed major operations worldwide. It accounts for between 1% and 70% of deliveries depending on the facilities or country assessed. In Egypt, the cesarean section rate is 22%, with higher rates seen in private hospitals. In 2015 ,incidence of cesarean section rate in Woman Health Hospital in Assiut university is 51.3% of all deliveries.
Different Operational techniques For cesarean section have been defined aimed at reducing surgical time, making the surgery easier and more efficient, lowering costs,decreasing the risk of adverse effects and postoperative morbidity, as well as length of hospital stay.
Also, Intraoperative blood loss is one of important complications during cesarean section. A systematic review included twenty one studies, in 2011, revealed that increase incidence of intraoperative blood loss and blood transfusion with increase number of cesarean deliveries.also anemia in the pregnancy increase maternal morbidities included intraoperative blood loss. In Egypt, prevalence of Iron deficiency anemia among pregnant women about 51% of pregnant women.
After baby born by cesarean section and the placenta has been extracted, uterine incision is sutured either by temporary removal of the uterus from the abdominal cavity (exteriorization of the uterus) to facilitate uterine incision repair or it is repaired within the abdominal cavity (in situ repair). There had been few randomized controlled trials comparing intraoperative and postoperative morbidity following exteriorization of the uterus with non-exteriorization. The conclusions drawn from these trials have been conflicting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exteriorization group | Other | Procedure: Repair of uterine incision, Procedure: Exteriorization of the uterusAfter delivery of the fetus and placenta, the surgeon bring uterus yet out from peritoneal cavity by manual handling of the uterus uterus from fundus and extracted out of the abdominal cavity before starting to close it. After repair of the uterus , uterus returned to abdominal cavity and repair anterior abdominal wall as following. |
| Non exteriorization group | Other | Procedure: Repair of uterine incision, Procedure: Non exteriorization of the uterusUterine incision will be repaired intra abdominally |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women in 28 weeks
- Women who will undergo repeated lower segment cesarean section
Key exclusion criteria (10 listed)
- First cesarean section
- Placenta previa.
- Rupture uterus.
- Classical caesarean section.(upper segment cesarean section)
- Sever Preeclampsia.
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 |
|---|---|---|
| Repair of uterine incision | Procedure or surgery | Exteriorization group, Non exteriorization group |
| Exteriorization of the uterus | Procedure or surgery | Exteriorization group |
| Non exteriorization of the uterus | Procedure or surgery | Non exteriorization group |
Primary outcome
Intraoperative blood loss (mL)
Time frame: 20 minutes
Postoperative Hemoglobin (gm/L)
Time frame: 20 minutes
1 secondary outcome
Duration of operation (minutes)
Time frame: 20 minutes
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 31 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Intrapartum Hemorrhage
Active, not recruiting
Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients, During the Intrapartum Period, Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding, Including Postpartum Haemorrhage
Post Partum Haemorrhage, Maternal Care Patterns
Not yet recruitingPhase 2
Role of Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Section
Post Partum Haemorrhage, Cesarean Section Surgery
Not yet recruiting
Prophylactic Regimen of Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative for Primary Prevention of Postpartum Hemorrhage in Intrapartum Cesarean Section Versus Intravenous Carbetocin Alone
Post Partum Hemorrhage
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 Repair of uterine incision, Exteriorization of the uterus and Non exteriorization of the uterus in people with Intrapartum 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 2 inclusion and 10 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 31 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. 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 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?
Intraoperative blood loss (mL) (time frame: 20 minutes). The study lists 2 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 31 Jul 2024.