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

Primary Purpose

Bleeding in Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
uterine compressive sutures
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding in Cesarean Section

Eligibility Criteria

16 Years - 42 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr Amany Salah
  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A: b lynch

group B : Nusicaa suture

Arm Description

B lynch uterine compressive suture was done

Nusicaa uterine compressive suture was done

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

blood loss
blood loss in ml
peripartum heamoglobin drop
differnce between pre and post operative heamoglobin (gm%)
procedure time
timing of suture (minutes)
need for devascularisation
need for devascularisation (YES/NO)
ICU admission
need for ICU admission(YES/NO)
Venous thromboembolism
Venous thromboembolism (YES/NO)
postoperative fever
temperature measurement in celsius

Full Information

First Posted
October 8, 2021
Last Updated
February 22, 2023
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05270473
Brief Title
Efficacy of Compression Sutures in Controlling Excessive Uterine Bleeding During Caesarean Section
Official Title
Efficacy of Different Uterine Compression Sutures in Controlling Excessive Uterine Bleeding During Caesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 20, 2022 (Actual)
Primary Completion Date
September 20, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding in Cesarean Section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomised controlled trials 2 groups
Masking
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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A: b lynch
Arm Type
Active Comparator
Arm Description
B lynch uterine compressive suture was done
Arm Title
group B : Nusicaa suture
Arm Type
Active Comparator
Arm Description
Nusicaa uterine compressive suture was done
Intervention Type
Procedure
Intervention Name(s)
uterine compressive sutures
Other Intervention Name(s)
b lynch and nusicaa sutures
Intervention Description
uterine compression sutures comaprison
Primary Outcome Measure Information:
Title
need for hysterctomy
Description
need for hysterctomy to control bleeding in cesarean section(YES/NO)
Time Frame
within 24 hours
Secondary Outcome Measure Information:
Title
blood loss
Description
blood loss in ml
Time Frame
within 6 hours
Title
peripartum heamoglobin drop
Description
differnce between pre and post operative heamoglobin (gm%)
Time Frame
within 6 hours
Title
procedure time
Description
timing of suture (minutes)
Time Frame
1 hour
Title
need for devascularisation
Description
need for devascularisation (YES/NO)
Time Frame
1 hour
Title
ICU admission
Description
need for ICU admission(YES/NO)
Time Frame
24 hours
Title
Venous thromboembolism
Description
Venous thromboembolism (YES/NO)
Time Frame
6 weeks
Title
postoperative fever
Description
temperature measurement in celsius
Time Frame
48 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed zeinhom, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Dr Amany Salah
City
Cairo
State/Province
Nasr City
ZIP/Postal Code
11591
Country
Egypt
Facility Name
Faculty of Medicine
City
Cairo
ZIP/Postal Code
11759
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
yes to be publisged
IPD Sharing Time Frame
6 months

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

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