B-Lynch Transverse Compression Suture Versus a Sandwich Technique (N&H Technique) for Complete Placenta Previa
NCT03682510 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2018-12-13
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
Interventions
- PROCEDURE
-
stepwise devascularization
stepwise devascularization begins with suture the placenta bed through uterine artery ligation, internal iliac artery ligation etc
- PROCEDURE
-
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.
- PROCEDURE
-
N&H sandwich technique
In the N\&H group, double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade.
Sponsors & Collaborators
-
Aswan University Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-31
- Primary Completion
- 2021-09-30
- Completion
- 2022-01-01
Countries
- Egypt
Study Locations
More Related Trials
-
Vertical Splitting of Muscle Layer in Lower Segment Cesarean Sections to Avoid Uterine Vessels Injury
NCT03224247 ·Status: UNKNOWN ·Phase: NA
-
Topical Tranexamic Acid Plus Bilateral Uterine Artery Ligation During Cesarean Delivery
NCT03741075 ·Status: UNKNOWN ·Phase: NA
-
Tranexamic Acid in Pregnant Women Undergoing Cesarean Section.
NCT03778242 ·Status: COMPLETED ·Phase: NA
-
Suture Material for Closure of Hysterotomy
NCT03026647 ·Status: WITHDRAWN
-
Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad,
NCT01892215 ·Status: COMPLETED ·Phase: NA
-
Push With Lower Uterine Segment Support
NCT02934516 ·Status: UNKNOWN ·Phase: NA
-
Placental Removal Method And Uterine Massage On Preventing Postpartum Hemorrhage
NCT06192836 ·Status: NOT_YET_RECRUITING
-
Comparing Blood Loss During Caesarean Section Between Manual Separation of Placenta & Conservative Management
NCT02480556 ·Status: COMPLETED ·Phase: NA
-
External Pop-Out Technique Versus Classic Head Extraction During Cesarean Section
NCT02755168 ·Status: COMPLETED ·Phase: NA
-
Methods of Placental Delivery and the Amount of Blood Loss During Cesarean Section
NCT02405663 ·Status: COMPLETED ·Phase: NA
-
Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage
NCT02229513 ·Status: COMPLETED ·Phase: NA
-
Extra-abdominal Removal of Placenta During CS
NCT02101450 ·Status: COMPLETED ·Phase: NA
-
Glove-loaded Foley's Catheter Tamponade for Cesarean Section for Placenta Previa
NCT03570723 ·Status: COMPLETED ·Phase: NA
-
Intact-cord Stabilisation and Physiology-based Cord Clamping in Caesarean Sections
NCT05461950 ·Status: COMPLETED
-
An Evaluation of Maternal Position During Cesarean Delivery
NCT02872181 ·Status: UNKNOWN ·Phase: NA
-
Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women Undergoing Elective Cesarean Section
NCT05072860 ·Status: UNKNOWN ·Phase: NA
-
Intra-cesarean Post Placental Introducer Withdrawal IUD Insertion Technique
NCT05788354 ·Status: COMPLETED ·Phase: NA
-
Effect of Tourniquet Binding of Cervical on the Blood Volume of Amniotic Fluid in Cesarean Section
NCT06254092 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Impact Of Maternal Spinal Anesthesia-Induced Hypotension At Scheduled Cesarean Delivery On Risk Development Of Transient Tachypnea Of Newborn And Fetal Acidosis
NCT06383624 ·Status: COMPLETED
-
Maternal Care Bundle to Attenuate Hypotension in Cesarean Section
NCT05468125 ·Status: UNKNOWN ·Phase: NA
-
The Effectiveness of a Care Bundle to Prevent Postpartum Hemorrhage After Cesarean Delivery
NCT06684080 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Novel Technique Of Uterine Cooling During Repeated Cesarean Section For Reducing Blood Loss
NCT03793153 ·Status: COMPLETED ·Phase: NA
-
Reducing Blood Loss During Cesarean Hysterectomy for Placenta Accreta Spectrum
NCT03570710 ·Status: COMPLETED ·Phase: NA
-
Effect of Non-Dissection of the Inferior Rectus Sheath on Intraoperative Blood Loss
NCT02762773 ·Status: TERMINATED ·Phase: NA
-
Influence of Injection Rate of Intrathecal Mixture of Local Anesthesia on Hypotension in Cesarean Section
NCT03517683 ·Status: COMPLETED ·Phase: NA