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

NCT03682510 | Unknown

• 1 other identifier: aswu/170/10/17
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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 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). 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.

Conditions

Cesarean Section Complications

Keywords

placenta previa; transverse b lynch suture; N&H sandwich technique

Outcome Measures

Primary Outcomes (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

  during the operation

Secondary Outcomes (3)

• need for blood transfusion

  24 hours postoperative

• Hemoglobin concentration

  ist 24 hours postoperative

• need of extra surgical maneuvers

  during operation

Study Arms (3)

stepwise devascularization

ACTIVE COMPARATOR

routine stepwise devascularization

Procedure: stepwise devascularization

B-Lynch Transverse Compression Suture

ACTIVE COMPARATOR

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.

Procedure: B-Lynch Transverse Compression Suture group

N&H technique

EXPERIMENTAL

In 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.

Procedure: N&H sandwich technique

Interventions

stepwise devascularization PROCEDURE

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

stepwise devascularization

B-Lynch Transverse Compression Suture group PROCEDURE

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.

B-Lynch Transverse Compression Suture

N&H sandwich technique PROCEDURE

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

N&H technique

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women need a cesarean section for placenta previa
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

AswanUH

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 24, 2018
• Study Start: October 31, 2018
• Primary Completion: September 30, 2021
• Study Completion: January 1, 2022
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

EG (1)