Recruiting NCT06695793
Niche Investigated: Closure of Hysterotomy & Evaluation of 3 Suturing Techniques (Running, Interrupted, and Locked)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interrupted Sutures, Locked Sutures, Running Continuous Sutures.
- Who it may be relevant to
- Registry conditions: Caesarean Scar Niche. Basic parameters: 18 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aims to explore the impact of three different suturing techniques (Running, Interrupted \& Locked) that used to close the uterine incision at the cesarean section on the formation of a cesarean scar niche
Interventions
- Procedure Interrupted Sutures
The first layer of uterine incision will be closed using individual, separate sutures placed at regular intervals along the incision line. Each suture will be tied independently, ensuring adequate apposition of uterine tissue, followed by a second layer of running continuous sutures. - Procedure Locked Sutures
The first layer of uterine incision will be closed using continuous sutures placed along the uterine incision, incorporating a locking technique at specified intervals to prevent unraveling. The knots will be securely tied to maintain tissue approximation, followed by a second layer of running continuous sutures. - Biological Running Continuous Sutures
Double layer closure of uterine incision using running continuous suture used to close the uterine incision without interruption, providing seamless tissue approximation throughout the incision length.
Primary outcome measures
- Presence of caesarean scar niche and its dimensions. [Time frame: 6-12 weeks post-cesarean section]
Secondary outcome measures (2)
- Operative time [Time frame: during operation]
- Estimate blood loss [Time frame: during operation]
Eligibility criteria
Inclusion criteria
- Women with a singleton pregnancy scheduled for elective cesarean section
- Gestational age at the time of cesarean section between 38 and 40 weeks.
- Willingness to participate in the study and provide informed consent
- Age between 18 and 35 years old.
- BMI <30
Exclusion criteria
- Known uterine anomalies or previous uterine surgery (e.g, myomectomy, uterine septum resection)
- Pre-existing medical conditions contraindicating cesarean delivery or affecting uterine healing (e.g., Anemia, Diabetes)
- Current smokers.
- Non-cephalic presentation of the fetus.
- Low-lying anterior wall placenta and placenta previa.
- Inability to provide informed consent (e.g., cognitive impairment, language barrier)
- Any condition deemed by the attending physician to pose a risk to the participant or compromise the study's integrity, for example, Patients who will require excessive suturing for further hemostasis or those who require ligation of one or both uterine arteries
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 5 centers
- Cairo University — Cairo
- Cairo University — Cairo
- Cairo University — Cairo
- Cairo University — Cairo
- Cairo University — Cairo
Identifiers
NCT: NCT06695793 · MD-308-2024