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Comparison of N&H Sandwich Technique and Cesarean Hysterectomy in Management of Placenta Accreta Spectrum

Primary Purpose

Cesarean Section Complications

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cesarean hysterectomy
N&H sandwich technique
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section Complications focused on measuring cesarean section, placenta accreta spectrum, N&H sandwich technique

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • all pregnant women with a full-term pregnancy with placenta accreta spectrum

Exclusion Criteria:

  • Patients with a cardiac, hepatic, renal or thromboembolic disease.
  • patients with pelvic endometriosis and adnexal mass.
  • those presented with severe antepartum hemorrhage will be excluded
  • known coagulopathy
  • twin pregnancy

Sites / Locations

  • Aswan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

cesarean hysterectomy

N&H sandwich technique

Arm Description

Elective Cesarean hysterectomy will be planned at 37-38 weeks of gestation. An adequate amount of blood products was prepared to be available for transfusion. The operation will be performed by the same multidisciplinary team, including two expert obstetricians, an assistant, an expert anesthesiologist, and a pediatrician.

In the N&H group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade was performed

Outcomes

Primary Outcome Measures

intraoperative blood loss
measures the intraoperative blood loss by direct and gravimetric methods

Secondary Outcome Measures

postoperative blood loss
measures the intraoperative blood loss by direct and gravimetric methods
need of blood transfusion
number of unites of blood transfusion
need of other surgical maneuvers
for example internal iliac artery ligation
operative time
time from skin incision to skin closure

Full Information

First Posted
October 5, 2018
Last Updated
December 11, 2018
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03701386
Brief Title
Comparison of N&H Sandwich Technique and Cesarean Hysterectomy in Management of Placenta Accreta Spectrum
Official Title
Comparison of N&H Sandwich Technique and Cesarean Hysterectomy in Management of Placenta Accreta Spectrum: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University 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 placenta accreta spectrum (PAS)is one of the most common reasons for cesarean hysterectomy Which associated with high rates of severe maternal morbidity (40%-50%), with reported mortality rates up to 7%. And, a cesarean hysterectomy might not be considered first-line treatment for women who have a strong desire for future fertility. Conservative management of PAS defines all procedures that aim to avoid peripartum hysterectomy and its related morbidity and consequences. The main types of conservative management which have been described in the literature: the extirpative technique (manual removal of the placenta); leaving the placenta in situ or the expectant approach; one-step conservative surgery and the Triple-P procedure. These methods have been used alone or in combination and in many cases with additional procedures such as those proposed by interventional radiology.
Detailed Description
patients were allocated to one of two groups. Group (I): patients will be received N&H technique Group (II): patients will be received cesarean hysterectomy. In the N&H group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade was performed 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, about5 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. (iii) another transverse compression suture undertook above the first one by 3 cm and below the hysterotomy incision by 2 cm. (iv) At the end of the suture application and before tying the knots, the internal os of the cervix was identified and a double-way 20 Fr Foley's catheter with a 30-50-ml balloon (Medical Industries, 10th of Ramadan City, Egypt) was inserted through the cervix to be handled by an assistant through the vagina and fixed to the patient's lower limb after inflation of the catheter balloon by 80 ml warm saline and pulling it against the lower uterine segment between the two transverse sutures . Only one catheter was used for tamponade. (v) Lastly ties the sutures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications
Keywords
cesarean section, placenta accreta spectrum, N&H sandwich technique

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The eligible participant will be allocated to groups, group one will receive cesarean hysterectomy and group 2 will be received N&H sandwich technique
Masking
None (Open Label)
Masking Description
no masking
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cesarean hysterectomy
Arm Type
Active Comparator
Arm Description
Elective Cesarean hysterectomy will be planned at 37-38 weeks of gestation. An adequate amount of blood products was prepared to be available for transfusion. The operation will be performed by the same multidisciplinary team, including two expert obstetricians, an assistant, an expert anesthesiologist, and a pediatrician.
Arm Title
N&H sandwich technique
Arm Type
Experimental
Arm Description
In the N&H group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade was performed
Intervention Type
Procedure
Intervention Name(s)
cesarean hysterectomy
Intervention Description
Elective cesarean hysterectomy will be planned at 37-38 weeks of gestation. An adequate amount of blood products was prepared to be available for transfusion. Delivery will be performed by the same multidisciplinary team, including two expert obstetricians, an assistant, an expert anesthesiologist, and a pediatrician.
Intervention Type
Procedure
Intervention Name(s)
N&H sandwich technique
Intervention Description
In the N&H group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade will be performed
Primary Outcome Measure Information:
Title
intraoperative blood loss
Description
measures the intraoperative blood loss by direct and gravimetric methods
Time Frame
during the operation
Secondary Outcome Measure Information:
Title
postoperative blood loss
Description
measures the intraoperative blood loss by direct and gravimetric methods
Time Frame
24 hours postoperative
Title
need of blood transfusion
Description
number of unites of blood transfusion
Time Frame
ist 24 hours postoperative
Title
need of other surgical maneuvers
Description
for example internal iliac artery ligation
Time Frame
during the operation
Title
operative time
Description
time from skin incision to skin closure
Time Frame
during the operation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant female with placenta accreta spectrum
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all pregnant women with a full-term pregnancy with placenta accreta spectrum Exclusion Criteria: Patients with a cardiac, hepatic, renal or thromboembolic disease. patients with pelvic endometriosis and adnexal mass. those presented with severe antepartum hemorrhage will be excluded known coagulopathy twin pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany f sallam, md
Phone
01022336052
Ext
002
Email
hany.farouk@aswu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hany f sallam, md
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hany f sallam, md
Phone
01092440504
Ext
002
Email
nahla.elsayed@aswu.ed.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of N&H Sandwich Technique and Cesarean Hysterectomy in Management of Placenta Accreta Spectrum

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