Bleeding in Cesarean SectionNCT05270473
Efficacy of Compression Sutures in Controlling Excessive Uterine Bleeding During Caesarean Section
A study testing uterine compressive sutures in people with Bleeding in Cesarean Section, run by Ain Shams Maternity Hospital at 2 sites in Egypt.
Trial summary
The investigators found that B- Lynch suture is more effective than Nausicca suture in controlling excessive uterine bleeding during cesarean section and avoiding the need of hysterectomy. Also, the investigators found that B- lynch suture needs shorter procedure time with less blood loss compared to Nausicca suture. Read more about this study
- Who is it for?
- Ages 16 to 42 years, women only
- Conditions the study is for
- Bleeding in Cesarean Section
- What is being tested?
- uterine compressive sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Mar 2022to 20 Oct 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 16 to 42 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients delivering by cesarean section with postpartum haemorrhage(intended for conservative management) as in
- Non morbidly adherent placenta praevia.
- Cases of uterine atony as in (Failed tocolysis, Twins, Polyhydramnios and History of postpartum haemorrhage).
- After failed conservative management of excessive uterine massage and ecbolics
Who cannot join
- 1- Severely haemodynamic instablility needing immediate hysterectomy. 2- Morbidly adherent placenta: accrete, increta or percreta. 3- Patients with coagulopathy:
- Receiving anticoagulant therapy.
- With thrombocytopenia or thrombasthenia.
- known coagulation factor defect. 4 -Distorted uterus as unicornuate, bicornuate, fibroid uterus and adenomyosis uteri.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Dr Amany Salah
Cairo, Nasr City, 11591
Faculty of Medicine
Cairo, 11759
About this study
Official title: Efficacy of Different Uterine Compression Sutures in Controlling Excessive Uterine Bleeding During Caesarean Section
The investigators found that B- Lynch suture is more effective than Nausicca suture in controlling excessive uterine bleeding during cesarean section and avoiding the need of hysterectomy.
Also, the investigators found that B- lynch suture needs shorter procedure time with less blood loss compared to Nausicca suture.
Consequently the investigators recommend the use of B-Lynch suture as a compressive uterine suture to control excessive uterine bleeding during cesarean section and avoid the need of hysterectomy.
As a result of this study the investigators recommend further studies to compare different uterine compressive suture to verify the most effective uterine compressive suture.
Read the detailed description
The objective of this study is to compare the efficacy of Nausicaa suture and B -lynch suture in controlling excessive uterine bleeding during cesarean section and avoiding the need for hystserctomy.
The investigators established this randomized controlled trial on participants with excessive uterine bleeding during cesarean section not responding to uterine massage and ecbolics in obstetric operative theatre in Ain Shams Maternity Hospitals.
During cesarean section, sixty participants who suffered from excessive uterine bleeding during cesarean section and not responding to uterine massage and ecbolics and who are willing to participate in the study and gave informed consent had Nausicaa or B-Lynch uterine compressive suture after randomizations using opaque sealed envelopes.
The selection of the type of suture done after allocation of women into two groups as llows:
Group (A):
Participants allocated in this group will have Nausicca suture done. Nausicaa suture will be applied by using round bodied, 3/8 circle curved needle, 70mm with 2-metric polyglactan suture. Suturing will be done by needle transfixing from the uterine serosa lateral to the bleeding area (or invaded myometrium) inside the uterine cavity. The needle will then be threaded along a horizontal course inside the uterine cavity until it encompassed the bleeding area, finally emerges at the other side of the uterine serosa. The sutures penetrated the full thickness of the myometrium without stitching the anterior and posterior walls together. Care will be taken to avoid transfixing any engorged parametrial vessels. A flat surgical knot will be then tied as tightly as possible above the serosa. Using these healthy myometrium as the anchoring points for needle transfixation, we will not encounter tissue destruction by the ligature. To achieve a better compression effect, the assistant often needed to clench the sutured myometrium while the operator ties off the knots. Additional sutures will made approximately 1.5-2 cm parallel to the previous stitches until haemostasis is achieved.
Group (B):
Participants allocated in this group will have B- lynch suture done. B-Lynch suture will be applied by using round bodied, 3/8 circle curved needle, 70mm with 2-metric polyglactan suture. Suturing will done according to method described by B-lynch et al. (1997) by starting in the uterus 3 cm from the right lower edge of the uterine incision and 3 cm from the right lateral border then passes through the uterine cavity to emerge at the upper incision margin 3 cm above and approximately 4 cm from the lateral border (because the uterus widens from below upwards), It will is be passed over to compress the uterine fundus, suture will pass posteriorly and vertically to enter the posterior wall of the uterine cavity at the same level as the upper anterior entry point, it will be pulled under moderate tension assisted by manual compression exerted by the first assistant. The suture will be passed through posteriorly and vertically over the fundus to lie anteriorly and vertically compressing the fundus on the left side as occurred on the right. The needle is passed in the same fashion on the left side through the uterine cavity and out approximately 3 cm anteriorly and below the lower incision margin on the left side. The two lengths of the suture are will be tight, assisted by bi-manual compression to minimise trauma and to achieve or aid compression and the principal surgeon will throw a surgical knot.
The two sutures were compare regarding need for hysterectomy, amount of blood loss will be assessed by number of soaked towels and suction titration, peripartum haemoglobin level drop (%) and haematocrit value change (%), number of received blood components (packed RBCs- fresh frozen plasma and platelets), procedure time (minutes), need for devascularisation, venous thromboembolism, postoperative pain and fever, hospital stay, number and cost of suture material used.
- Conditions
- Bleeding in Cesarean Section
- Being tested
- uterine compressive sutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterine compressive suturesProcedure or surgery
Also called b lynch and nusicaa sutures
uterine compression sutures comaprison
| Study group | Role | What they receive |
|---|---|---|
| group A: b lynch | Active comparator | B lynch uterine compressive suture was done Receives: Procedure: uterine compressive sutures |
| group B : Nusicaa suture | Active comparator | Nusicaa uterine compressive suture was done Receives: Procedure: uterine compressive sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
need for hysterctomy
need for hysterctomy to control bleeding in cesarean section(YES/NO)
Measured: within 24 hours
Secondary outcomes (7)
blood loss
blood loss in ml
Measured: within 6 hours
peripartum heamoglobin drop
differnce between pre and post operative heamoglobin (gm%)
Measured: within 6 hours
procedure time
timing of suture (minutes)
Measured: 1 hour
need for devascularisation
need for devascularisation (YES/NO)
Measured: 1 hour
ICU admission
need for ICU admission(YES/NO)
Measured: 24 hours
Venous thromboembolism
Venous thromboembolism (YES/NO)
Measured: 6 weeks
postoperative fever
temperature measurement in celsius
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start20 Mar 2022
- Primary completion20 Sep 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding in Cesarean SectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled trials 2 groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Salah El Din Abd El Hafeez Abd El Hady,MSC, Ain Shams Maternity Hospital
- Investigators
- Ahmed zeinhom, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270473
- Sponsor's protocol ID
- MD250/2019
- Status last verified
- Feb 2023
- First submitted
- 8 Oct 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: yes to be publisged
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Uterine Compression Sutures in Controlling Excessive Uterine Bleeding During Caesarean Section
- ClinicalTrials.gov ID
- NCT05270473
- Acronym / sponsor ID
- MD250/2019
- Conditions
- Bleeding in Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 8 Mar 2022 (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.
The investigators found that B- Lynch suture is more effective than Nausicca suture in controlling excessive uterine bleeding during cesarean section and avoiding the need of hysterectomy.
Also, the investigators found that B- lynch suture needs shorter procedure time with less blood loss compared to Nausicca suture.
Consequently the investigators recommend the use of B-Lynch suture as a compressive uterine suture to control excessive uterine bleeding during cesarean section and avoid the need of hysterectomy.
As a result of this study the investigators recommend further studies to compare different uterine compressive suture to verify the most effective uterine compressive suture.
Detailed description
The objective of this study is to compare the efficacy of Nausicaa suture and B -lynch suture in controlling excessive uterine bleeding during cesarean section and avoiding the need for hystserctomy.
The investigators established this randomized controlled trial on participants with excessive uterine bleeding during cesarean section not responding to uterine massage and ecbolics in obstetric operative theatre in Ain Shams Maternity Hospitals.
During cesarean section, sixty participants who suffered from excessive uterine bleeding during cesarean section and not responding to uterine massage and ecbolics and who are willing to participate in the study and gave informed consent had Nausicaa or B-Lynch uterine compressive suture after randomizations using opaque sealed envelopes.
The selection of the type of suture done after allocation of women into two groups as llows:
Group (A):
Participants allocated in this group will have Nausicca suture done. Nausicaa suture will be applied by using round bodied, 3/8 circle curved needle, 70mm with 2-metric polyglactan suture. Suturing will be done by needle transfixing from the uterine serosa lateral to the bleeding area (or invaded myometrium) inside the uterine cavity. The needle will then be threaded along a horizontal course inside the uterine cavity until it encompassed the bleeding area, finally emerges at the other side of the uterine serosa. The sutures penetrated the full thickness of the myometrium without stitching the anterior and posterior walls together. Care will be taken to avoid transfixing any engorged parametrial vessels. A flat surgical knot will be then tied as tightly as possible above the serosa. Using these healthy myometrium as the anchoring points for needle transfixation, we will not encounter tissue destruction by the ligature. To achieve a better compression effect, the assistant often needed to clench the sutured myometrium while the operator ties off the knots. Additional sutures will made approximately 1.5-2 cm parallel to the previous stitches until haemostasis is achieved.
Group (B):
Participants allocated in this group will have B- lynch suture done. B-Lynch suture will be applied by using round bodied, 3/8 circle curved needle, 70mm with 2-metric polyglactan suture. Suturing will done according to method described by B-lynch et al. (1997) by starting in the uterus 3 cm from the right lower edge of the uterine incision and 3 cm from the right lateral border then passes through the uterine cavity to emerge at the upper incision margin 3 cm above and approximately 4 cm from the lateral border (because the uterus widens from below upwards), It will is be passed over to compress the uterine fundus, suture will pass posteriorly and vertically to enter the posterior wall of the uterine cavity at the same level as the upper anterior entry point, it will be pulled under moderate tension assisted by manual compression exerted by the first assistant. The suture will be passed through posteriorly and vertically over the fundus to lie anteriorly and vertically compressing the fundus on the left side as occurred on the right. The needle is passed in the same fashion on the left side through the uterine cavity and out approximately 3 cm anteriorly and below the lower incision margin on the left side. The two lengths of the suture are will be tight, assisted by bi-manual compression to minimise trauma and to achieve or aid compression and the principal surgeon will throw a surgical knot.
The two sutures were compare regarding need for hysterectomy, amount of blood loss will be assessed by number of soaked towels and suction titration, peripartum haemoglobin level drop (%) and haematocrit value change (%), number of received blood components (packed RBCs- fresh frozen plasma and platelets), procedure time (minutes), need for devascularisation, venous thromboembolism, postoperative pain and fever, hospital stay, number and cost of suture material used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomised controlled trials 2 groups
| Arm | Type | Receives |
|---|---|---|
| group A: b lynch | Active comparator | Procedure: uterine compressive suturesB lynch uterine compressive suture was done |
| group B : Nusicaa suture | Active comparator | Procedure: uterine compressive suturesNusicaa uterine compressive suture was done |
Who may qualify
- Ages
- 16 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients delivering by cesarean section with postpartum haemorrhage(intended for conservative management) as in
- Non morbidly adherent placenta praevia.
- Cases of uterine atony as in (Failed tocolysis, Twins, Polyhydramnios and History of postpartum haemorrhage).
- After failed conservative management of excessive uterine massage and ecbolics
Key exclusion criteria (4 listed)
- 1- Severely haemodynamic instablility needing immediate hysterectomy. 2- Morbidly adherent placenta: accrete, increta or percreta. 3- Patients with coagulopathy:
- Receiving anticoagulant therapy.
- With thrombocytopenia or thrombasthenia.
- known coagulation factor defect. 4 -Distorted uterus as unicornuate, bicornuate, fibroid uterus and adenomyosis uteri.
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 |
|---|---|---|
| uterine compressive suturesAlso: b lynch and nusicaa suturesuterine compression sutures comaprison | Procedure or surgery | group A: b lynch, group B : Nusicaa suture |
Primary outcome
need for hysterctomy
Time frame: within 24 hours
need for hysterctomy to control bleeding in cesarean section(YES/NO)
7 secondary outcomes
blood loss
Time frame: within 6 hours
peripartum heamoglobin drop
Time frame: within 6 hours
procedure time
Time frame: 1 hour
need for devascularisation
Time frame: 1 hour
ICU admission
Time frame: 24 hours
Venous thromboembolism
Time frame: 6 weeks
postoperative fever
Time frame: 48 hours
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 Feb 2023.
- Individual participant dataSharing planned: Yes. yes to be publisged
Related trials for Bleeding in Cesarean Section
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Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
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RecruitingPhase 2
Oxytocin Pharmacokinetics and Pharmacodynamics
Post Partum Hemorrhage, Cesarean Section Complications
Not yet recruitingPhase 4
Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR)
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RecruitingPhase 2
Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
Blood Loss, Surgical, Blood Loss, Postoperative
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Exteriorization Versus In Situ Hysterotomy Repair During Cesarean: Effects on Uterine Tone
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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.
Ahmed zeinhom, MD study director
Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uterine compressive sutures in people with Bleeding in Cesarean Section, run by Ain Shams Maternity Hospital at 2 sites 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 4 inclusion and 4 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 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
need for hysterctomy (time frame: within 24 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 Feb 2023.