Double Vers Single in Cesarean Incision

NCT05276518 | Unknown DMC

• 1 other identifier: 3/3
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the effect of single versus double layer closure of caesarean scar on the residual myometrium on the short \& intermediate term.

Conditions

Cesarean Scar Defect

Outcome Measures

Primary Outcomes (1)

• The residual myometrial thickness at 3 months by trans vaginal us.

  Evaluation of the residual myometrial thickness at 3 months after the caesarean section by trans vaginal ultrasonography saline infusion sonohystrography will be done ( in a full bladder patients , Casco speculum will be inserted into vagina followed by insertion of soft non balloon tip catheter 5 French into uterus through vagina then cervix. The speculum was extracted to insert the transducer, 5-10 cc of saline was inserted through the catheter into the uterine cavity to allow the lining of the uterus to be imaged clearly on the ultrasound screen and showed any endometrial abnormality,. Residual myometrial thickness "RMT" is the distance between the tip of the hypo echoic triangle and the surface of anterior uterine wall measured by mm.)

  3 months

Study Arms (2)

o Group (1): 30 cases who will undergo Two Layer Uterine Closure

o After the delivery the first group will undergo Two Layer Uterine Closure: Double-layer closure of the uterine incision will be performed using unlocked continuous Polyglactin thread sutures(1/0) for both layers, with a large portion of the myometrium and the endometrium included in the first layer. The second layer was a continuous running suture that imbricate the first layer, including serosal and myometrial tissue.

Procedure: Closure of cesarean section incision

o Group (2): 30 cases who will undergo single layer uterine closure.

The second group will undergo continuous unlocked sutures in a single layer, Uterine closure will begin from one corner of the incision and then the uterine incision wound is closed using Polyglactin thread include endometrium, myometrium and serosa

Procedure: Closure of cesarean section incision

Interventions

Closure of cesarean section incision PROCEDURE

After the delivery the first group will undergo Two Layer Uterine Closure: Double-layer closure of the uterine incision will be performed using unlocked continuous Polyglactin thread sutures(1/0) for both layers, with a large portion of the myometrium and the endometrium included in the first layer. The second layer was a continuous running suture that imbricate the first layer, including serosal and myometrial tissue. The second group will undergo continuous unlocked sutures in a single layer, Uterine closure will begin from one corner of the incision and then the uterine incision wound is closed using Polyglactin thread include endometrium, myometrium and serosa.

o Group (1): 30 cases who will undergo Two Layer Uterine Closure; o Group (2): 30 cases who will undergo single layer uterine closure.

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Randomization will be done using computer generated random sequence. Study population will be randomized into one of the two groups: * Group (1): 30 cases who will undergo Two Layer Uterine Closure (A) * Group (2): 30 cases who will undergo single layer uterine closure (B)

You may qualify if:

• Singleton pregnancy.
• Gestational age between 37 completed weeks to 42 weeks.
• Patients undergoing elective primary caesarean section.

You may not qualify if:

• Pregnant women who declined to participate.
• History of uterine surgery (e.g. hysterotomy, myomectomy, perforation, caesarean section).
• Presence of maternal disease (diabetes mellitus, connective tissue disorders, uterine malformations).
• Women Diagnosed with Placenta Accreta Spectrum during the current pregnancy
• Multiple pregnancy.
• Chorioamnionitis.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Sara abdelrazik Ramadan hamad

Cairo, Egypt

RECRUITING

Study Officials

• Mohamed Hamed, Asst . Prof

  Ain Shams Maternity Hospital

  STUDY DIRECTOR

Central Study Contacts

Sara Abdelrazik, Bachelor

CONTACT

01092762108; Hamadsara358@gmail.com

Mohamed Hamed, Asst . Prof

CONTACT

01226067272

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The principal investigator

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 11, 2022
• Study Start: April 20, 2022
• Primary Completion: October 20, 2022
• Study Completion: April 1, 2023
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)