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Cesarean Scar DefectNCT05276518

Double Vers Single in Cesarean Incision

An observational study of Cesarean Scar Defect, run by Ain Shams Maternity Hospital at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 16 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cesarean Scar Defect
What is being tested?
Closure of cesarean section incision
Type of treatment
Surgery or procedure
How many people
60 participants
Where
1 siteEgypt
Study dates
20 Apr 2022to 1 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

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)

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Sara Abdelrazik, Bachelor contact

01092762108

Hamadsara358@gmail.com

Mohamed Hamed, Asst . Prof contact

01226067272

Egypt1 site, 1 recruiting
  • Sara abdelrazik Ramadan hamad

    Cairo

    Sara Abdelrazik, Bachelor, 01092762108, Hamadsara358@gmail.com

    Mohamed Hamad, MD, 01226067272, mhs_vagus2009@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: Effect of Single Layer Versus Double Layer Suturing on Healing of Caesarean Uterine Scar: A Randomized Controlled Trial

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

Read the detailed description

Caesarean section is the fetal delivery through an open abdominal incision (laparotomy) and an incision in the uterus (hysterotomy). The first caesarean documented occurred in 1020 AD, and since then, the procedure has evolved tremendously. It is now the most common surgery performed in Egypt, with over 1 million women delivered by caesarean every year. The caesarean delivery rate worldwide rose from 5% in 1970 to 31.9% in 2016 An optimal uterine closure should provide better scar healing. Closure of the uterine incision needs to be considered with regards to benefit and potential harm in order to offer the best available surgical care to women undergoing caesarean section. Surgical suturing technique and mechanical tension affecting the surgical wound are the most important factors related to the incisional integrity, especially for minimizing postoperative caesarean delivery scar defects .

Currently, a low-transverse incision is the preferred method of hysterotomy during caesarean delivery. This incision has traditionally been repaired with a two-layer closure. A two-layer closure usually involves a continuous, unlocking layer of absorbable suture with an addition of adds muscular fold to cover the first layer. Studies showed that women whose uterine incisions have been closed by double-layer following caesarean section experienced greater advantages in terms of residual myometrium thickness, healing ratio (residual myometrium thickness/adjacent myometrium thickness), and dysmenorrhea .

The safe cut off thickness of scar in post LSCS uterus varies from 1.5 to 3.5 mm; the thinning of the site is the cause of worry of dehiscence scar or rupture in next pregnancy. Closure of the uterine incision is a key step in caesarean delivery, correct approximation of the cut margins is not guaranteed .

This may be possibly due to edges getting overlapped; and, after remodelling and the process of the healing, thickness of the site of incision is significantly reduced. There is also a very high possibility of inter surgeon variability. It was felt that if there is a suturing technique which ensures correct approximation of all the layers with nil or minimal possibility of inters operator variability, there will not be any thinning of lower segment caesarean section LSCS site, and scarred uterus repaired in this manner will be able to withstand the stress of labor in future .

A growing body of evidence suggests that the surgical technique for uterus closure influences uterine scar defect, but there is still no consensus about optimal uterus closure. Some techniques seem to have the potential to decrease the risk of short-term complications, while others have long-term benefits, such as reduced risk of uterine rupture. Some maternal symptoms are related to the appearance of the uterine scar, and more specifically to a niche in the caesarean scar as a surrogate marker. niche is defined as an indentation in the myometrium of ≥2 mm in depth and is detectable by transvaginal ultrasound (TVUS), preferably with contrast to limit false negatives. Complications in subsequent pregnancies, including uterine rupture and placenta accreta spectrum disorders, are associated with thin residual myometrium .

Many variations in CS technique have been studied. For example, single-layer unlocked uterine incision closure has been compared to double-layer unlocked uterine incision closure. Double layer locked closure has compared to single-layer locked closure, Fear of scar rupture is one of risks involved in a post caesarean pregnancy .

This had led to an increased rate of repeat caesarean delivery in today's times. Closure of the uterine incision is a key step in caesarean section, and it is imperative that an optimal surgical technique be employed for closing a uterine scar. This technique should be able to withstand the stress of subsequent labor. In the existing techniques of uterine closure, single or double layer, correct approximation of the cut margins, that is, decidua-to-decidua, myometrium to myometrium, serosa to serosa is not guaranteed. Also, there are high chances of inter surgeon variability. It was felt that if a suturing technique which ensures correct approximation of all the layers mentioned above with nil or minimal possibility of inter operator variability existed, there will not be any thinning of lower segment caesarean section (LSCS). Further, a scarred uterus repaired in this manner will be able to withstand the stress of labor in future .

To assess the healing of scar and the risk of uterine rupture and other complication, ultrasonography is used in the evaluation of uterine scar 6 weeks after delivery. It has generally been found that, the thicker the uterine scar, the lower the rate of complications. This may be due to that the thicker scar is stronger, and thus performs better than a thinner one .

Being tested
Closure of cesarean section incision

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Closure of cesarean section incisionProcedure or surgery

    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.

Study groups in NCT05276518
Study groupRoleWhat they receive
o Group (1): 30 cases who will undergo Two Layer Uterine Closureo 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.
Receives: 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
Receives: Procedure: Closure of cesarean section incision

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2022
  2. Study start20 Apr 2022
  3. Primary completion20 Oct 2022 (estimated)
  4. Study completion1 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05276518
Sponsor's protocol ID
3/3
Status last verified
Aug 2022
First submitted
3 Mar 2022
Last updated
16 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cesarean Scar Defect, run by Ain Shams Maternity Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sara Abdelrazik, Bachelor (01092762108, Hamadsara358@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The residual myometrial thickness at 3 months by trans vaginal us. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.

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