Efficacy of Compression Sutures in Controlling Excessive Uterine Bleeding During Caesarean Section

Sponsor
Ain Shams Maternity Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05270473
Collaborator
(none)
60
2
2
7
30
4.3

Study Details

Study Description

Brief 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.

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: uterine compressive sutures
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomised controlled trials 2 groupsrandomised controlled trials 2 groups
Masking:
Single (Outcomes Assessor)
Masking Description:
Double blinding is difficult because the observer will see the type of procedure done. However, the measured outcomes are objective and unlikely to be biased by lack of blinding.
Primary Purpose:
Treatment
Official Title:
Efficacy of Different Uterine Compression Sutures in Controlling Excessive Uterine Bleeding During Caesarean Section
Actual Study Start Date :
Mar 20, 2022
Anticipated Primary Completion Date :
Sep 20, 2022
Anticipated Study Completion Date :
Oct 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: group A: b lynch

B lynch uterine compressive suture was done

Procedure: uterine compressive sutures
uterine compression sutures comaprison
Other Names:
  • b lynch and nusicaa sutures
  • Active Comparator: group B : Nusicaa suture

    Nusicaa uterine compressive suture was done

    Procedure: uterine compressive sutures
    uterine compression sutures comaprison
    Other Names:
  • b lynch and nusicaa sutures
  • Outcome Measures

    Primary Outcome Measures

    1. need for hysterctomy [within 24 hours]

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

    Secondary Outcome Measures

    1. blood loss [within 6 hours]

      blood loss in ml

    2. peripartum heamoglobin drop [within 6 hours]

      differnce between pre and post operative heamoglobin (gm%)

    3. procedure time [1 hour]

      timing of suture (minutes)

    4. need for devascularisation [1 hour]

      need for devascularisation (YES/NO)

    5. ICU admission [24 hours]

      need for ICU admission(YES/NO)

    6. Venous thromboembolism [6 weeks]

      Venous thromboembolism (YES/NO)

    7. postoperative fever [48 hours]

      temperature measurement in celsius

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 42 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients delivering by cesarean section with postpartum haemorrhage(intended for conservative management) as in
    1. Non morbidly adherent placenta praevia.

    2. 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

    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr Amany Salah Cairo Nasr City Egypt 11591
    2 Faculty of Medicine Cairo Egypt 11759

    Sponsors and Collaborators

    • Ain Shams Maternity Hospital

    Investigators

    • Study Director: Ahmed zeinhom, MD, Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amany Salah El Din Abd El Hafeez Abd El Hady,MSC, MD Student, Ain Shams Maternity Hospital
    ClinicalTrials.gov Identifier:
    NCT05270473
    Other Study ID Numbers:
    • MD250/2019
    First Posted:
    Mar 8, 2022
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 10, 2022