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

NCT ID: NCT03701386

Last Updated: 2018-12-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2022-01-01

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.

Conditions

Cesarean Section Complications

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

cesarean hysterectomy

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.

Group Type: ACTIVE_COMPARATOR

cesarean hysterectomy

Intervention Type: 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.

N&H sandwich technique

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

Group Type: EXPERIMENTAL

N&H sandwich technique

Intervention Type: 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

Interventions

cesarean hysterectomy

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

N&H sandwich technique

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hany f sallam, md

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

Aswan University

Aswān, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

hany f sallam, md

Role: CONTACT

Phone: 01022336052

Email: hany.farouk@aswu.edu.eg

Facility Contacts

hany f sallam, md

Role: primary

Other Identifiers

aswu /296/9/18

Identifier Type: -

Identifier Source: org_study_id