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

NCT03701386 | Unknown

• 1 other identifier: aswu /296/9/18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Keywords

cesarean section; placenta accreta spectrum; N&H sandwich technique

Outcome Measures

Primary Outcomes (1)

• intraoperative blood loss

  measures the intraoperative blood loss by direct and gravimetric methods

  during the operation

Secondary Outcomes (4)

• postoperative blood loss

  24 hours postoperative

• need of blood transfusion

  ist 24 hours postoperative

• need of other surgical maneuvers

  during the operation

• operative time

  during the operation

Study Arms (2)

cesarean hysterectomy

ACTIVE COMPARATOR

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.

Procedure: cesarean hysterectomy

N&H sandwich technique

EXPERIMENTAL

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

Procedure: N&H sandwich technique

Interventions

cesarean hysterectomy PROCEDURE

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.

cesarean hysterectomy

N&H sandwich technique PROCEDURE

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

N&H sandwich technique

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: pregnant female with placenta accreta spectrum
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

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

Study Officials

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hany f sallam, md

CONTACT

01022336052; hany.farouk@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: The eligible participant will be allocated to groups, group one will receive cesarean hysterectomy and group 2 will be received N\&H sandwich technique

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 10, 2018
• Study Start: November 1, 2018
• Primary Completion: October 30, 2021
• Study Completion: January 1, 2022
• Last Updated: December 13, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)