Cesarean Section ComplicationsNCT04518176
Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins
A study testing bilateral uterine artery ligation and Oxytocin in people with Cesarean Section Complications, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Objective to assess the effectiveness of prophylactic bilateral uterine artery ligation (BUAL) in reducing the incidence of postpartum hemorrhage during cesarean delivery among women with twin pregnancy Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- bilateral uterine artery ligation and Oxytocin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 31 Aug 2022
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women undergoing cesarean section
- twin pregnancy
Who cannot join
- Placenta previa.
- Ante-partum hemorrhage.
- patient refuse to participate
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University Hospital
Aswān, 81528
Hany F Sallam, MD, 0122336052 ext. 002, hany.farouk@aswu.edu.eg
Nahla W Shady, MD, 01092440504 ext. 002, nahla.elsayed@aswu.edu.eg
About this study
Official title: Clinical Outcomes of Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins: A Randomized Controlled Trial
Objective to assess the effectiveness of prophylactic bilateral uterine artery ligation (BUAL) in reducing the incidence of postpartum hemorrhage during cesarean delivery among women with twin pregnancy
Read the detailed description
A randomized clinical trial at Aswan University Maternity Hospital, Egypt. Women with twin pregnancy undergoing scheduled or emergency cesarean were randomized into two groups. In the BUAL group, women underwent BUAL before placental delivery; in the control group, women had cesarean delivery without BUAL. The primary outcome was the estimated blood loss during a cesarean
- Conditions
- Cesarean Section Complications
- Being tested
- bilateral uterine artery ligation, Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral uterine artery ligationProcedure or surgery
Also called BUAL
The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally
OxytocinDrug
20 units by slow intravenous drip injection
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | patients with twin pregnancy undergoing cesarean section underwent bilateral uterine artery ligation and received oxytocin. Receives: Procedure: bilateral uterine artery ligation; Drug: Oxytocin |
| control group | Active comparator | patients with twin pregnancy undergoing cesarean section received oxytocin only. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean Blood loss after placental separation
by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set
Measured: 30 minutes
Secondary outcomes (2)
Number of Participants with postpartum hemorrhage
number pf participants with blood loss > 1000ml
Measured: 12 hours
The number of participant needed for blood transfusion
Calculation of the number of participant needed for blood transfusion
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Sep 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- 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
- Model description
- randomized controlled study
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- nahla w Shady, md, Study chair, Aswan universirty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518176
- Sponsor's protocol ID
- aswu/279/8/18
- Status last verified
- Sep 2020
- First submitted
- 15 Aug 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04518176
- Acronym / sponsor ID
- aswu/279/8/18
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 19 Aug 2020 (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.
Objective to assess the effectiveness of prophylactic bilateral uterine artery ligation (BUAL) in reducing the incidence of postpartum hemorrhage during cesarean delivery among women with twin pregnancy
Detailed description
A randomized clinical trial at Aswan University Maternity Hospital, Egypt. Women with twin pregnancy undergoing scheduled or emergency cesarean were randomized into two groups. In the BUAL group, women underwent BUAL before placental delivery; in the control group, women had cesarean delivery without BUAL. The primary outcome was the estimated blood loss during a cesarean
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: bilateral uterine artery ligation, Drug: Oxytocinpatients with twin pregnancy undergoing cesarean section underwent bilateral uterine artery ligation and received oxytocin. |
| control group | Active comparator | Drug: Oxytocinpatients with twin pregnancy undergoing cesarean section received oxytocin only. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women undergoing cesarean section
- twin pregnancy
Key exclusion criteria (3 listed)
- Placenta previa.
- Ante-partum hemorrhage.
- patient refuse to participate
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 |
|---|---|---|
| bilateral uterine artery ligationAlso: BUALThe peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally | Procedure or surgery | study group |
| Oxytocin20 units by slow intravenous drip injection | Drug | control group, study group |
Primary outcome
mean Blood loss after placental separation
Time frame: 30 minutes
by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set
2 secondary outcomes
Number of Participants with postpartum hemorrhage
Time frame: 12 hours
The number of participant needed for blood transfusion
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
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.
nahla w Shady, md study chair
Aswan universirty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral uterine artery ligation and Oxytocin in people with Cesarean Section Complications, run by Aswan University Hospital 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 3 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 21 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hany f Sallam, md (+20102435461 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean Blood loss after placental separation (time frame: 30 minutes). 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 21 Sep 2020.