Cesarean Section Complications, Myometrial Remodeling, Scar Niche, Suture Techniques
Conditions
Keywords
Uterine niche, Myometrial closure, Residual myometrial thickness, Randomized controlled trial, Cesarean scar disorder
Brief summary
The purpose of the study is to determine whether two-layered simple interrupted myometrial suturing is superior to double-layered continuous suturing for the prevention of uterine niche formation after primary cesarean section.
Detailed description
All primigravidae at or beyond 28 weeks' gestation undergoing primary cesarean section for any indication were assessed for eligibility. All participants provided written informed consent before enrolment. All patients received preoperative antibiotic prophylaxis at induction of anesthesia and postoperative prophylaxis for 24 h. A single intramuscular dose of oxytocin 10 IU was administered during the first 24 h postpartum. After confirming eligibility and obtaining consent, a trained nurse selected an envelope for each patient and revealed the allocation to the operating obstetrician. Patients were blinded to group allocation. * Study Group: Two-layered simple interrupted suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum. * Control Group: Double-layered continuous suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum. The parietal peritoneum was left open in all cases. Hemostasis was ensured, and the number of additional hemostatic sutures was recorded. A braided polyglycolic acid 0-1 suture was used in all cases. All other steps of cesarean section were standardized. At 6 months postpartum, all patients were evaluated by a single blinded sonographer experienced in niche assessment. First, transvaginal ultrasound was performed to exclude pregnancy or pelvic pathology, followed by saline-infusion sonohysterography (2D, sagittal and coronal views). A niche was defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness were recorded. Menstrual history was obtained by an independent obstetrician/gynecologist, documenting spotting days, total bleeding days, amenorrhea, and contraceptive use.
Interventions
PROCEDUREPrimary Cesarean Section with two-layered simple interrupted suturing of the myometrium
All steps of cesarean section were standardized for both arms except for the type of myometrial suturing where two-layered simple interrupted suturing of the myometrium was applied.
PROCEDUREPrimary Cesarean Section with double-layered continuous suturing of the myometrium
All steps of cesarean section were standardized for both arms except for the type of myometrial suturing where double-layered continuous suturing of the myometrium was applied.
DIAGNOSTIC_TESTSaline-infusion Sonohysterography
At 6 months postpartum, all patients were evaluated by a single blinded sonographer experienced in niche assessment. First, transvaginal ultrasound was performed to exclude pregnancy or pelvic pathology, followed by saline-infusion sonohysterography (2D, sagittal and coronal views). A niche was defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness were recorded.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Acceptance to participate and willingness to attend follow-up for 6 months postpartum. * No plans for pregnancy within the follow-up period.
Exclusion criteria
* Known Müllerian anomalies or uterine fibroids. * Previous uterine surgery. * Multiple gestation. * Chorioamnionitis, placenta previa, or placental abruption. * Preeclampsia/eclampsia. * Hepatic or renal dysfunction, uncontrolled diabetes, or systemic disease. * Peripartum hemoglobin \< 10 g/dL. * Chronic corticosteroid use or smoking. * Inability to provide consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of uterine niche formation after primary cesarean section. | At 6 months postpartum | Using saline-infusion sonohysterography (2D, sagittal and coronal views), a niche was defined as ≥ 2 mm myometrial indentation at the scar site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uterine niche measurements | At 6 months postpartum | Using saline-infusion sonohysterography (2D, sagittal and coronal views),niche depth, length, width, and residual myometrial thickness are to be recorded. |
| Total operative time. | Intraoperative | The operation room nurse recorded the time lapse between the skin incision and the end of skin suturing. |
| The correlation between niche width and menstrual cycle abnormalities. | At 6 months postpartum | For participants diagnosed with uterine niche, menstrual history was obtained by an independent obstetrician/gynecologist, documenting spotting days, total bleeding days, amenorrhea, and contraceptive use. |
| The association between active labour at the time of cesarean and niche formation. | Cervical dilatation was evaluated immediately preoperative, while the association was evaluated at 6 months postpartum | Active labour in primigravida was identified when the cervical dilatation is equal to or more than 3 cm. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORAHMED ALNEZAMY, MD
Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University
Outcome results
None listed