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

Cesarean Section Complications Clinical Trial

Official title:

Comparison of N&H Sandwich Technique and Cesarean Hysterectomy in Management of Placenta Accreta Spectrum: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03701386
• Other study ID #: aswu /296/9/18
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: December 2018
• Source: Aswan University Hospital
• Contact: hany f sallam, md
• Phone: 01022336052
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Placenta Accreta

Intervention

Procedure:
• 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.
• 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

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative blood loss	measures the intraoperative blood loss by direct and gravimetric methods	during the operation
Secondary	postoperative blood loss	measures the intraoperative blood loss by direct and gravimetric methods	24 hours postoperative
Secondary	need of blood transfusion	number of unites of blood transfusion	ist 24 hours postoperative
Secondary	need of other surgical maneuvers	for example internal iliac artery ligation	during the operation
Secondary	operative time	time from skin incision to skin closure	during the operation