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Cesarean Section ComplicationsNCT03682510

B-Lynch Transverse Compression Suture Versus a Sandwich Technique (N&H Technique) for Complete Placenta Previa

A study testing stepwise devascularization, B-Lynch Transverse Compression Suture group and N&H sandwich technique in people with Cesarean Section Complications, run by Aswan University Hospital at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Obstetric hemorrhage is estimated to be responsible for about 30% of all maternal deaths and is the leading direct etiology of maternal mortality worldwide . Especially in developing countries, hemorrhage is by far the leading cause of mortality and morbidity, with 140,000 women dying of PPH worldwide each year, which… 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?
stepwise devascularization, B-Lynch Transverse Compression Suture group and N&H sandwich technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteEgypt
Study dates
31 Oct 2018to 1 Jan 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

  • all pregnant women with a single term fetus scheduled for elective CS for complete PP and invited them to participate in the study. PP was defined as a placenta completely covering the cervical os in ultrasound examination

Who cannot join

  • 1-Patients with the cardiac, hepatic, renal or thromboembolic disease. 2- patients with the high possibility of the morbid adherent placenta. 3-known coagulopathy and 4- those presented with severe antepartum hemorrhage will be excluded

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • AswanUH

    Aswān, 81528

    Hany F Sallam, md, 01022336052 ext. 002, hany.farouk@aswu.edu.eg

    Nahla w Shady, md, 0101092440504 ext. 002, nahla.elsayed@aswu.ed.eg

    Recruiting

Other trials in Egypt

About this study

Official title: A Randomized Clinical Trial Comparing the Efficacy of B-Lynch Transverse Compression Suture Versus a Sandwich Technique (N&H Technique) at the Time of Cesarean Delivery for Complete Placenta Previa

Obstetric hemorrhage is estimated to be responsible for about 30% of all maternal deaths and is the leading direct etiology of maternal mortality worldwide . Especially in developing countries, hemorrhage is by far the leading cause of mortality and morbidity, with 140,000 women dying of PPH worldwide each year, which equates to 1 death every 4 min . The United Nations Millennium Development Fifth Goal, to reduce 75 % of maternal mortality by 2015 that not reached yet, cannot be held without significant improvements in postpartum hemorrhage (PPH) related mortality.

Placenta previa (PP) is an obstetric condition that is closely linked with potentially life-threatening hemorrhage with varied incidence approximately four or five per 1000 pregnancies. Placenta previa is diagnosed when the placenta obstructs part or all the cervical os during antenatal ultrasonography. Placenta previa may be subclassified using ultrasound scan to be "major or complete" (implanted across the cervix) or "minor" (not implanted across the cervix).

Read more

Currently, there is a dramatic increase in the incidence of placenta previa due to the increasing rate of cesarean delivery combined with increasing maternal age (6) It is considered one of the causes of the increased need for blood transfusion and cesarean hysterectomy.

Various conservative measures have been developed to avoid hysterectomy and preserve fertility in patients with PP. Bilateral Uterine artery ligation (BUAL) is one of the reported surgical procedures carried out in these cases as it is easy and quick. It can be used alone or with adjunctive measures with a fair success rate. The aim is to reduce the blood supply to the uterus and to prevent PPH.

There are a few methods to prevent and treat placenta previa bleeding immediately after cesarean delivery and control intra-operative bleeding during the cesarean operation. A safe intra-operative maneuver to arrest bleeding due to placenta previa is required. However, there is no gold standard treatment of placenta previa hemorrhage. The aims of the study to assess the effect of the novel sandwich technique for the control of hemorrhage during cesarean section due to placenta previa (double Transverse Compression Suture at the lower uterine segment plus Intrauterine inflated Foley's Catheter Balloon, (N\&H technique) on control of massive bleeding due to central placenta previa in comparison with B-Lynch Transverse Compression Suture.

Read the detailed description

All participants will undergo a detailed history, general, abdominal and vaginal examinations, body mass index (BMI) was calculated and pelvic ultrasound examination was undertaken for all participants. The participants who fulfilled the eligibility criteria were explained about the study with the beneficial and possible adverse effects of lidocaine. Informed consent was obtained from them after that participant will be randomized into 3 groups: group 1 [N\&H technique], group 2 [N\&H technique] and group (3) stepwise devascularization Eligible participants will be allocated to one of 3 groups after induction of general anesthesia and prior to the operation and before skin incision. The abdomen was exposed through Pfannenstiel incision, after skin incision, the subcutaneous fat and abdominal fascia were opened crosswise, and the rectus muscle was opened on the midline, the parietal peritoneum was opened longitudinally, the visceral peritoneum was opened transversely and dissected downwards with the bladder and kept against symphysis pubis by a Doyen retractor, followed by transverse incision of the uterus at the upper border of the placenta to avoid transplacental incision which provokes severe bleeding . The fetus was delivered.

20 IU oxytocin was given IV infusion after IIAL to prevent premature separation of placenta which provoked severe bleeding then placenta delivery was done.

In the B-Lynch Transverse Compression Suture group, After acceptable control of bleeding from the placental bed, uses the suture material 1 VICRYL with a 70mm ½ circle needle mounted on a 90 cms VICRYL suture. We use the needle blunt ended to puncture the uterus 3 cms above the upper margin of the incision posteriorly and behind the vascular bundle.

The needle is retrieved through the cavity of the uterus and pulled inferiorly with the suture material lying on the posterior wall of the uterine cavity. The needle then perforates the posterior wall of the uterus 3 cms below the inferior margin of the Caesarean incision and exists behind the vascular bundle of the same side of the uterus retrieved and runs on the surface of the lower segment below the incision margin parallel to it and taking a 1 cm bite of tissue for stabilization running to the other side. After encircling the para-uterine vasculature, the needle then perforates the posterior side of the uterus behind the vascular bundle entering the uterine cavity. The suture can lie freely on the posterior wall of the uterine cavity and exists 3 cms above the upper margin of the Caesarean incision. It exits posteriorly and behind the vascular bundle to meet the suture from the other side.

It is essential that the ureters are identified by palpation or visual observation after the bladder is displaced inferiorly and held by traction. Any observed bleeding should be dealt with in the usual way. At the end of the suture application and before tying the knots, the lower segment is compressed again transversely whilst the suture is held taut to ensure that bleeding has ceased by swabbing the vagina again.

A wide pore drain was then inserted in the Douglas pouch, and the abdominal wall was repaired. In the case of conservative treatment protocol failure, cesarean hysterectomy was performed

Being tested
stepwise devascularization, B-Lynch Transverse Compression Suture group, N&H sandwich technique
Keywords
placenta previa, transverse b lynch suture, N&H sandwich technique
Medical subject headings
Placenta Previa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • stepwise devascularizationProcedure or surgery

    stepwise devascularization begins with suture the placenta bed through uterine artery ligation, internal iliac artery ligation etc

  • B-Lynch Transverse Compression Suture groupProcedure or surgery

    After acceptable control of bleeding from the placental bed, uses the suture material 1 VICRYL with a 70mm ½ circle needle mounted on a 90 cms VICRYL suture. We use the needle blunt ended to puncture the uterus 3 cms above the upper margin of the incision posteriorly and behind the vascular bundle.

    The needle is retrieved through the cavity of the uterus and pulled inferiorly with the suture material lying on the posterior wall of the uterine cavity. The needle then perforates the posterior wall of the uterus 3 cms below the inferior margin of the Caesarean incision and exists behind the vascular bundle of the same side of the uterus retrieved and runs on the surface of the lower segment below the incision margin parallel to it and taking a 1 cm bite of tissue for stabilization running to the other side. After encircling the para-uterine vasculature, the needle then perforates the posterior side of the uterus behind the vascular bundle entering the uterine cavity.

  • N&H sandwich techniqueProcedure or surgery

    In the N\&H group, double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade.

Study groups in NCT03682510
Study groupRoleWhat they receive
stepwise devascularizationActive comparatorroutine stepwise devascularization
Receives: Procedure: stepwise devascularization
B-Lynch Transverse Compression SutureActive comparatorAfter acceptable control of bleeding from the placental bed, uses the suture material 1 VICRYL with a 70mm ½ circle needle mounted on a 90 cms VICRYL suture. We use the needle blunt ended to puncture the uterus 3 cms above the upper margin of the incision posteriorly and behind the vascular bundle. The needle is retrieved through the cavity of the uterus and pulled inferiorly with the suture material lying on the posterior wall of the uterine cavity. The needle then perforates the posterior wall of the uterus 3 cms below the inferior margin of the Caesarean incision and exists behind the vascular bundle of the same side of the uterus retrieved and runs on the surface of the lower segment below the incision margin parallel to it and taking a 1 cm bite of tissue for stabilization running to the other side.
Receives: Procedure: B-Lynch Transverse Compression Suture group
N&H techniqueExperimentalIn the N\&H group, double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade. As follow: (i) 100-cm Vicryl no. 1 was thrown to form two nearly equal parts (each 50 cm) on a blunt semicircular 70-mm needle, the curve of the needle was straightened. (ii) The needle transfixed the right side of the uterine wall from anterior to posterior, about 2 cm below the hysterotomy incises posterior, then the needle transfixed the left side of the uterine wall from posterior to anterior, about 2 cm below the hysterotomy incision.
Receives: Procedure: N&H sandwich technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. estimation of intraoperative blood loss (ml).

    Intraoperative blood loss was measured suction bottle and the difference in weight (in grams) between the dry and the soaked operation sheets and towels (1 gram = 1 ml.). Post-operative blood loss was measured through intraperitoneal suction drain which measured every 12 hours and on removing the drain. After that, the total blood loss was calculated by the addition of intraoperative and postoperative blood loss.and vaginal bleeding

    Measured: during the operation

Secondary outcomes (3)
  1. need for blood transfusion

    need for blood transfusion

    Measured: 24 hours postoperative

  2. Hemoglobin concentration

    pre and postoperative hemoglobin estimation

    Measured: ist 24 hours postoperative

  3. need of extra surgical maneuvers

    internal iliac ligation or hysterectomy

    Measured: during operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2018
  2. Study start31 Oct 2018
  3. Primary completion30 Sep 2021 (estimated)
  4. Study completion1 Jan 2022 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The participants who fulfilled the eligibility criteria were explained about the study with the beneficial and possible adverse effects of lidocaine. Informed consent was obtained from them after that participant were randomized into 3 groups: group 1 \[N\&H technique\], group 2 \[N\&H technique\] and group 3 stepwise devascularization
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03682510
Sponsor's protocol ID
aswu/170/10/17
Status last verified
Dec 2018
First submitted
21 Sep 2018
Last updated
13 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing stepwise devascularization, B-Lynch Transverse Compression Suture group and N&H sandwich technique 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 1 inclusion and 1 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 13 Dec 2018. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

estimation of intraoperative blood loss (ml). (time frame: during the operation). 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 13 Dec 2018.

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