Cesarean Section Complications, Scar Niche, Scarred Uterus
Conditions
Keywords
Repeated cesarean section, Uterine niche, Scar resection, Residual myometrial thickness, Randomized controlled trial
Brief summary
The purpose of the study is to evaluate whether resection of the previous cesarean scar at repeat cesarean delivery reduces uterine niche formation and related morbidity without increasing operative risks.
Detailed description
After eligibility and consenting, multigravida women with ≥1 prior cesarean section scheduled for repeat cesarean section at ≥28 weeks' gestation for any indication were randomized to * Study group: During repeat cesarean section, the prior uterine scar was resected. After creating the bladder flap, the uterus was incised 5 mm cranial to the scar and extended laterally 5 mm beyond its ends. Following delivery, a 1 cm segment of uterine wall (5 mm above and below the scar) was excised. The incision edges were approximated with a central vertical mattress suture, followed by double-layer continuous myometrial closure (including decidua) and visceral peritoneum closure. * Control group: Standard repeat cesarean section without scar resection, followed by identical double-layer and peritoneal closure. All procedures were performed by obstetricians trained in the protocol. All women received standard preoperative antibiotics, 24-hour postoperative prophylaxis, and 10 units intramuscular oxytocin after delivery. At 6 months postpartum, all participants will undergo transvaginal ultrasound and saline infusion sonohysterography performed by a blinded, experienced examiner. Sagittal and coronal views willl be obtained, and niche presence, depth, length, width, and residual myometrial thickness are to be recorded. Obstetricians were informed of assignment, while participants and ultrasound assessor are blinded.
Interventions
PROCEDURERepeated cesarean section with previous uterine cesarean section scar resection
After creating the bladder flap, the uterus was incised 5 mm cranial to the scar and extended laterally 5 mm beyond its ends. After delivery of the newborn, a 1 cm segment of uterine wall (5 mm above and 5 mm below the scar) was excised. The incision edges were approximated with a central vertical mattress suture, followed by double-layer continuous myometrial closure including decidua with visceral peritoneum closure.
PROCEDURERepeated cesarean section without uterine scar resection
Standard repeat cesarean section without scar resection, followed by double-layer continuous myometrial closure including decidua with visceral peritoneum closure.
DIAGNOSTIC_TESTSaline-infusion Sonohysterography
At 6 months postpartum, all participants are to be 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 is defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness are to be recorded.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Eligible women were randomized (1:1) using a computer-generated sequence in blocks of 10. Allocation was concealed in sequentially numbered, opaque, sealed envelopes opened by a trained nurse after consent. Obstetricians were informed of assignment, while participants , investigator, and ultrasound assessors remained blinded.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* ≥1 prior cesarean section at ≥28 weeks' gestation. * Undergoing repeat cesarean section for any indication. * Provided informed consent and agreed to 6-month postpartum follow-up. * Not planning pregnancy during follow-up.
Exclusion criteria
* Uterine fibroids, multiple gestation, chorioamnionitis, placenta previa, placental abruption, or preeclampsia/eclampsia. * Hepatic or renal dysfunction, uncontrolled diabetes, or hemoglobin \<10 g/dL. * Systemic uncontrolled disease, chronic corticosteroid use, or smoking. * Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of uterine niche formation after repeated cesarean section | At 6 months postpartum | Using saline-infusion sonohysterography (2 dimensional, sagittal and coronal views). A niche is defined as ≥ 2 mm myometrial indentation at the scar site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uterine niche measurments | At 6 months postpartum | Using saline-infusion sonohysterography (2 dimensional, 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 mean estimated intraoperative blood loss. | Intraoperative | The estimated intraoperative blood loss was evaluated by weighting all surgical sponges, swabs, and drapes before and after use. Using this formula: Blood Loss (mL) = (Wet weight - Dry weight in grams) = mL of blood lost then add this to the volume of blood collected in suction canisters and subtract any irrigation or amniotic fluid. |
| The number of additional hemostatic sutures needed. | immediately postoperative | The the obstetrician who performed the procedure recorded this in the participant file. |
| Menstrual characteristics among participants with uterine niche | At 6 months postpartum | For participants diagnosed with uterine niche, menstrual history is to obtained by an independent obstetrician/gynecologist, documenting number of spotting days, total bleeding days, amenorrhea, and contraceptive use. |
Countries
Egypt
Outcome results
None listed