Cesarean Section ComplicationsNCT07229222
A Two-Layered Simple Interrupted Myometrial Suturing Reduces Uterine Niche Formation After Primary Cesarean Section
A study testing Primary Cesarean Section with two-layered simple interrupted suturing of the myometrium, Primary Cesarean Section with double-layered continuous suturing of the myometrium and Saline-infusion Sonohysterography in people with Cesarean Section Complications and Scar Niche, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section Complications, Scar Niche, Myometrial Remodeling
- What is being tested?
- Primary Cesarean Section with two-layered simple interrupted suturing of the myometrium, Primary Cesarean Section with double-layered continuous suturing of the myometrium and Saline-infusion Sonohysterography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Feb 2025to 30 Dec 2025
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Acceptance to participate and willingness to attend follow-up for 6 months postpartum.
- No plans for pregnancy within the follow-up period.
Who cannot join
- 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.
Show all 9Show fewer
- Peripartum hemoglobin < 10 g/dL.
- Chronic corticosteroid use or smoking.
- Inability to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decidual-Sparing Two-Layered Simple Interrupted Myometrial Suturing With Visceral Peritoneal Closure Reduces Uterine Niche Formation After Primary Cesarean Section: A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Primary Cesarean Section with two-layered simple interrupted suturing of the myometrium, Primary Cesarean Section with double-layered continuous suturing of the myometrium, Saline-infusion Sonohysterography
- Keywords
- Uterine niche, Myometrial closure, Residual myometrial thickness, Randomized controlled trial, Cesarean scar disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Cesarean Section with two-layered simple interrupted suturing of the myometriumProcedure or surgery
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.
Primary Cesarean Section with double-layered continuous suturing of the myometriumProcedure or surgery
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 SonohysterographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Primary Cesarean Section with two-layered simple interrupted suturing of the myometrium; Diagnostic Test: Saline-infusion Sonohysterography |
| 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. Receives: Procedure: Primary Cesarean Section with double-layered continuous suturing of the myometrium; Diagnostic Test: Saline-infusion Sonohysterography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months postpartum
Secondary outcomes (4)
Uterine niche measurements
Using saline-infusion sonohysterography (2D, sagittal and coronal views),niche depth, length, width, and residual myometrial thickness are to be recorded.
Measured: At 6 months postpartum
Total operative time.
The operation room nurse recorded the time lapse between the skin incision and the end of skin suturing.
Measured: 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.
Measured: 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.
Measured: Cervical dilatation was evaluated immediately preoperative, while the association was evaluated at 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start13 Feb 2025
- Primary completion15 Jun 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel Latif Ahmed Alnezamy, Benha University
- Investigators
- AHMED ALNEZAMY, MD, Principal investigator, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229222
- Sponsor's protocol ID
- RC13-2-2025
- Status last verified
- Feb 2026
- First submitted
- 13 Nov 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29536581Monteagudo 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.
PubMed 11587017Klein 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.
PubMed 37506497Vervoort 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.
PubMed 28703935Vikhareva 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.
PubMed 21343754Baranov 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.
PubMed 25720922Osser 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.
PubMed 20034000Antoine 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.
PubMed 34726789Tsuji 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.
PubMed 40055610
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decidual-Sparing Two-Layered Simple Interrupted Myometrial Suturing With Visceral Peritoneal Closure Reduces Uterine Niche Formation After Primary Cesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07229222
- Acronym / sponsor ID
- RC13-2-2025
- Keywords
- Uterine niche, Myometrial closure, Residual myometrial thickness, Randomized controlled trial, Cesarean scar disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-layered simple interrupted suturing of the myometrium | Active comparator | Procedure: Primary Cesarean Section with two-layered simple interrupted suturing of the myometrium, Diagnostic Test: Saline-infusion SonohysterographyTwo-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 | Procedure: Primary Cesarean Section with double-layered continuous suturing of the myometrium, Diagnostic Test: Saline-infusion SonohysterographyDouble-layered continuous suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Acceptance to participate and willingness to attend follow-up for 6 months postpartum.
- No plans for pregnancy within the follow-up period.
Key exclusion criteria (9 listed)
- Known Müllerian anomalies or uterine fibroids.
- Previous uterine surgery.
- Multiple gestation.
- Chorioamnionitis, placenta previa, or placental abruption.
- Preeclampsia/eclampsia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Cesarean Section with two-layered simple interrupted suturing of the myometriumAll 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. | Procedure or surgery | Two-layered simple interrupted suturing of the myometrium |
| Primary Cesarean Section with double-layered continuous suturing of the myometriumAll 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. | Procedure or surgery | Double-layered continuous suturing of the myometrium. |
| Saline-infusion SonohysterographyAt 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. | Diagnostic test | Double-layered continuous suturing of the myometrium., Two-layered simple interrupted suturing of the myometrium |
Primary outcome
Rate of uterine niche formation after primary cesarean section.
Time frame: 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.
4 secondary outcomes
Uterine niche measurements
Time frame: At 6 months postpartum
Total operative time.
Time frame: Intraoperative
The correlation between niche width and menstrual cycle abnormalities.
Time frame: At 6 months postpartum
The association between active labour at the time of cesarean and niche formation.
Time frame: Cervical dilatation was evaluated immediately preoperative, while the association was evaluated at 6 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 29536581Jordans 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.
- Background: PubMed 11587017Monteagudo 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.
- Background: PubMed 37506497Klein 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.
- Background: PubMed 28703935Vervoort 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.
- Background: PubMed 21343754Vikhareva 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.
- Background: PubMed 25720922Baranov 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.
- Results publication: PubMed 20034000Osser 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.
- Results publication: PubMed 34726789Antoine 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.
- Results publication: PubMed 40055610Tsuji 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHMED ALNEZAMY, MD principal investigator
Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Cesarean Section with two-layered simple interrupted suturing of the myometrium, Primary Cesarean Section with double-layered continuous suturing of the myometrium and Saline-infusion Sonohysterography in people with Cesarean Section Complications and Scar Niche, run by Benha University 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 27 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of uterine niche formation after primary cesarean section. (time frame: At 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07229222, which also lists 9 linked publications.
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 27 Feb 2026.