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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two-layered simple interrupted suturing of the myometrium | Active Comparator | Two-layered simple interrupted suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum. |
|
| Double-layered continuous suturing of the myometrium. | Active Comparator | Double-layered continuous suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Cesarean Section with two-layered simple interrupted suturing of the myometrium | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of uterine niche formation after primary cesarean section. | Using saline-infusion sonohysterography (2D, sagittal and coronal views), a niche was defined as ≥ 2 mm myometrial indentation at the scar site. | At 6 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Uterine niche measurements | Using saline-infusion sonohysterography (2D, sagittal and coronal views),niche depth, length, width, and residual myometrial thickness are to be recorded. | At 6 months postpartum |
| Total operative time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AHMED ALNEZAMY, MD | Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha Univesity Hospital | Banhā | Qalyubia Governorate | 13512 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29536581 | Background | Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049. | |
| 11587017 |
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|
| Primary Cesarean Section with double-layered continuous suturing of the myometrium | Procedure | 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. |
|
| Saline-infusion Sonohysterography | Diagnostic Test | 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. |
|
The operation room nurse recorded the time lapse between the skin incision and the end of skin suturing.
| Intraoperative |
| The correlation between niche width and menstrual cycle abnormalities. | 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. | At 6 months postpartum |
| The association between active labour at the time of cesarean and niche formation. | Active labour in primigravida was identified when the cervical dilatation is equal to or more than 3 cm. | Cervical dilatation was evaluated immediately preoperative, while the association was evaluated at 6 months postpartum |
| Background |
| Monteagudo A, Carreno C, Timor-Tritsch IE. Saline infusion sonohysterography in nonpregnant women with previous cesarean delivery: the "niche" in the scar. J Ultrasound Med. 2001 Oct;20(10):1105-15. doi: 10.7863/jum.2001.20.10.1105. |
| 37506497 | Background | Klein Meuleman SJM, Min N, Hehenkamp WJK, Post Uiterweer ED, Huirne JAF, de Leeuw RA. The definition, diagnosis, and symptoms of the uterine niche - A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Aug;90:102390. doi: 10.1016/j.bpobgyn.2023.102390. Epub 2023 Jul 15. |
| 28703935 | Background | Vervoort A, Vissers J, Hehenkamp W, Brolmann H, Huirne J. The effect of laparoscopic resection of large niches in the uterine caesarean scar on symptoms, ultrasound findings and quality of life: a prospective cohort study. BJOG. 2018 Feb;125(3):317-325. doi: 10.1111/1471-0528.14822. Epub 2017 Aug 28. |
| 21343754 | Background | Vikhareva Osser O, Valentin L. Clinical importance of appearance of cesarean hysterotomy scar at transvaginal ultrasonography in nonpregnant women. Obstet Gynecol. 2011 Mar;117(3):525-532. doi: 10.1097/AOG.0b013e318209abf0. |
| 25720922 | Background | Baranov A, Gunnarsson G, Salvesen KA, Isberg PE, Vikhareva O. Assessment of Cesarean hysterotomy scar in non-pregnant women: reliability of transvaginal sonography with and without contrast enhancement. Ultrasound Obstet Gynecol. 2016 Apr;47(4):499-505. doi: 10.1002/uog.14833. Epub 2016 Feb 29. |
| 20034000 | Result | Osser OV, Jokubkiene L, Valentin L. Cesarean section scar defects: agreement between transvaginal sonographic findings with and without saline contrast enhancement. Ultrasound Obstet Gynecol. 2010 Jan;35(1):75-83. doi: 10.1002/uog.7496. |
| 34726789 | Result | Antoine C, Meyer JA, Silverstein JS, Alexander J, Oh C, Timor-Tritsch IE. The Impact of Uterine Incision Closure Techniques on Post-cesarean Delivery Niche Formation and Size: Sonohysterographic Examination of Nonpregnant Women. J Ultrasound Med. 2022 Jul;41(7):1763-1771. doi: 10.1002/jum.15859. Epub 2021 Nov 2. |
| 40055610 | Result | Tsuji S, Katsura D, Tokoro S, Inatomi A, Nobuta Y, Yoneoka Y, Amano T, Murakami T. Two-layer interrupted versus two-layer continuous sutures for preventing cesarean scar defect: a randomized controlled trial. BMC Pregnancy Childbirth. 2025 Mar 7;25(1):248. doi: 10.1186/s12884-025-07353-1. |