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Completed

NCT Number: NCT05770115

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

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

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy outpatient infertility clinic

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vicryl 1

Procedure

Double layer closure with split thickness with vicryl 1, in continuous, non-locked, 1 cm apart sutures.

Vicryl 2/0

Procedure

Double layer closure with split thickness with vicryl 2/0, in continuous, non-locked, 1 cm apart sutures.

Primary outcomes

  1. prevalence of uterine niche

    Time frame: 6 weeks

    using transvaginal ultrasound for detection of development of CS scar niche

Secondary outcomes

  1. operative time

    Time frame: 1 hour

    operative time in minutes is measured from the time of skin incision to time of skin closure

  2. size of cs niche

    Time frame: 6 weeks

    size of cs niche is measured in millimeters using transvaginal ultrasound.

  3. operative blood loss

    Time frame: 2 hours

    operative blood loss in milliliteres as indicated by the wieghing the towels before and after CS.

  4. postoperative haemoglobin

    Time frame: 24 hours

    measured in mg/dl as full blood count is done 24 hours postoperative.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 15, 2023
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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