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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Egypt

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.

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 groups in NCT05270473
Study groupRoleWhat they receive
group A: b lynchActive comparatorB lynch uterine compressive suture was done
Receives: Procedure: uterine compressive sutures
group B : Nusicaa sutureActive comparatorNusicaa 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.

  1. need for hysterctomy

    need for hysterctomy to control bleeding in cesarean section(YES/NO)

    Measured: within 24 hours

Secondary outcomes (7)
  1. blood loss

    blood loss in ml

    Measured: within 6 hours

  2. peripartum heamoglobin drop

    differnce between pre and post operative heamoglobin (gm%)

    Measured: within 6 hours

  3. procedure time

    timing of suture (minutes)

    Measured: 1 hour

  4. need for devascularisation

    need for devascularisation (YES/NO)

    Measured: 1 hour

  5. ICU admission

    need for ICU admission(YES/NO)

    Measured: 24 hours

  6. Venous thromboembolism

    Venous thromboembolism (YES/NO)

    Measured: 6 weeks

  7. 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.

  1. First posted8 Mar 2022
  2. Study start20 Mar 2022
  3. Primary completion20 Sep 2022
  4. Study completion20 Oct 2022

Resources

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)
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

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.

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