A Randomized Clinical Study Based on Comparison Between Closure of Uterine Incision With Vicryl 2/0 Versus Vicryl 1 in Development of Uterine Niche.

Study Overview
=================
Brief Summary
-----------------
The first group patients underwent double layer closure with split thickness with vicryl 2/0, in continuous, non- locked, 1 cm apart sutures, study group, and the second group, women underwent double layer closure with split thickness with vicryl 1, in continuous, non- locked, 1 cm apart sutures, control group. Then, all women in the study were followed up for development of niche within 1 to 6 weeks. The assessment after one week postpartum was with using trans-abdominal Ultrasound, then after two to six weeks postpartum with transvaginal Ultrasound

Detailed Description
-----------------
Caesarean section rates have increased worldwide over the past decades from 6.7 to 19.1%, with a current European CS rate of 25% of all births. CS is considered to be a safe procedure that can be life saving for both mother and child but the increasing trend draws more attention to adverse outcomes related to CSs. A relatively new long-term sequela is the niche in the uterine caesarean scar. A niche is defined as an indentation at the site of the uterine caesarean scar with a depth of at least 2 mm on ultrasound and is present in 56-84% of women after one or more CSs . It is realized that almost all of the increase in cesarean section rate is due to the increase in repeat operations, and primary cesarean deliveries for dystocia and fetal distress. These can be attributed to obstetric factors as increased primary cesarean delivery rate, failed induction. Maternal factors as Increased proportion of women > age 35, increased nulliparous women, increased elective primary cesarean deliveries and factors relating to the physician as Malpractice litigation concerns . The hypotheses can be divided into surgery-related factors and patient related factors. In their paper they focused on surgery-related factors since these could be easily modified and studied in future RCTs . These surgical-related factors include low (cervical) location of the uterine incision during a CS, Incomplete closure of the uterine wall, due to single-layer, endometrial saving closure technique or use of locking sutures and Surgical activities that may induce adhesion formation (i.e., non-closure of peritoneum, inadequate hemostasis, applied sutures, use of adhesion barriers). Without questions, the uterine niche presents a pathology that requires evaluation and intervention to mitigate its prevalence. The aim of this study is to compare between closures of uterine incision with Vicryl 2/0 versus Vicryl 1 in developing a uterine niche.

Official Title
-----------------
A Randomized Clinical Study Based on Comparison Between Closure of Uterine Incision With Vicryl 2/0 Versus Vicryl 1 in Development of Uterine Niche.

Conditions
-----------------
Cesarean Section; Dehiscence

Intervention / Treatment
-----------------
* Procedure: Vicryl 1
* Procedure: Vicryl 2/0


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton term pregnancy. Parity less than 5. Women who undergo 1st cesarean section whether in labor or not. Exclusion Criteria: Women with a previous CS. Previous major uterine surgery (e.g. laparoscopic or laparotomic fibroid resection, septum resection). Women with known causes of menstrual disorders (e.g. cervical dysplasia, communicating hydro-salpinx, uterine anomaly or endocrine disorders disturbing ovulation). Abnormally invasive placenta during the current pregnancy. Multiple gestation, polyhydramnios. Maternal Diabetes, anemia and connective tissue disorders. Women with Body mass index > 35. Women with valval varicosities.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>vicryl 2/0 | Procedure: Vicryl 2/0<br>* Double layer closure with split thickness with vicryl 2/0, in continuous, non-locked, 1 cm apart sutures.<br>|
| Active Comparator: Group B<br>vicryl 1 | Procedure: Vicryl 1<br>* Double layer closure with split thickness with vicryl 1, in continuous, non-locked, 1 cm apart sutures.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of uterine niche | using transvaginal ultrasound for detection of development of CS scar niche | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | operative time in minutes is measured from the time of skin incision to time of skin closure | 1 hour | 
| size of cs niche | size of cs niche is measured in millimeters using transvaginal ultrasound. | 6 weeks | 
| operative blood loss | operative blood loss in milliliteres as indicated by the wieghing the towels before and after CS. | 2 hours | 
| postoperative haemoglobin | measured in mg/dl as full blood count is done 24 hours postoperative. | 24 hours |