Clinical trial NCT03701386: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Keywords: cesarean section
placenta accreta spectrum
N&H sandwich technique
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: intraoperative blood loss
timeFrame: during the operation
Secondary outcomes:
measure: postoperative blood loss
timeFrame: 24 hours postoperative
measure: need of blood transfusion
timeFrame: ist 24 hours postoperative
measure: need of other surgical maneuvers
timeFrame: during the operation
measure: operative time
timeFrame: during the operation
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University Hospital
name: hany f sallam, md
role: PRINCIPAL_INVESTIGATOR
References: