Cesarean Section ComplicationsNCT07228858
Uterine Scar Resection During Repeat Cesarean Delivery to Prevent Uterine Niche Formation
A study testing Repeated cesarean section with previous uterine cesarean section scar resection, Repeated cesarean section without uterine scar resection 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 evaluate whether resection of the previous cesarean scar at repeat cesarean delivery reduces uterine niche formation and related morbidity without increasing operative risks. 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, Scarred Uterus
- What is being tested?
- Repeated cesarean section with previous uterine cesarean section scar resection, Repeated cesarean section without uterine scar resection 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
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Feb 2025to 30 Nov 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
- ≥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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uterine Scar Resection During Repeat Cesarean Delivery in a Simple Modification to Prevent Uterine Niche Formation: Results of a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Cesarean Section Complications, Scar Niche, Scarred Uterus
- Being tested
- Repeated cesarean section with previous uterine cesarean section scar resection, Repeated cesarean section without uterine scar resection, Saline-infusion Sonohysterography
- Keywords
- Repeated cesarean section, Uterine niche, Scar resection, Residual myometrial thickness, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated cesarean section with previous uterine cesarean section scar resectionProcedure or surgery
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.
Repeated cesarean section without uterine scar resectionProcedure or surgery
Standard repeat cesarean section without scar resection, followed by double-layer continuous myometrial closure including decidua with visceral peritoneum closure.
Saline-infusion SonohysterographyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| uterine scar resection | Active comparator | During repeat cesarean section, the previous uterine cesarean section scar was resected. Receives: Procedure: Repeated cesarean section with previous uterine cesarean section scar resection; Diagnostic Test: Saline-infusion Sonohysterography |
| Non scar resection | Active comparator | Standard repeat cesarean section without previous uterine cesarean section scar resection. Receives: Procedure: Repeated cesarean section without uterine scar resection; 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 repeated cesarean section
Using saline-infusion sonohysterography (2 dimensional, sagittal and coronal views). A niche is defined as ≥ 2 mm myometrial indentation at the scar site.
Measured: At 6 months postpartum
Secondary outcomes (5)
Total operative time.
The operation room nurse recorded the time lapse between the skin incision and the end of skin suturing.
Measured: Intraoperative
The mean estimated intraoperative blood loss.
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.
Measured: Intraoperative
The number of additional hemostatic sutures needed.
The the obstetrician who performed the procedure recorded this in the participant file.
Measured: immediately postoperative
Uterine niche measurments
Using saline-infusion sonohysterography (2 dimensional, sagittal and coronal views). Niche depth, length, width, and residual myometrial thickness are to be recorded.
Measured: At 6 months postpartum
Menstrual characteristics among participants with uterine niche
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.
Measured: 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 start9 Feb 2025
- Primary completion30 May 2025
- Study completion30 Nov 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
- 170 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
- NCT07228858
- Sponsor's protocol ID
- RC9-2-2025
- Status last verified
- Dec 2025
- First submitted
- 13 Nov 2025
- Last updated
- 29 Dec 2025
- 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 29536581Klein 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 28703935Baranov 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. High prevalence of defects in Cesarean section scars at transvaginal ultrasound examination. Ultrasound Obstet Gynecol. 2009 Jul;34(1):90-7. doi: 10.1002/uog.6395.
PubMed 19499514Osser 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 20034000Sholapurkar SL. Etiology of Cesarean Uterine Scar Defect (Niche): Detailed Critical Analysis of Hypotheses and Prevention Strategies and Peritoneal Closure Debate. J Clin Med Res. 2018 Mar;10(3):166-173. doi: 10.14740/jocmr3271w. Epub 2018 Jan 26.
PubMed 29416572Siraj SHM, Lional KM, Tan KH, Wright A. Repair of the myometrial scar defect at repeat caesarean section: a modified surgical technique. BMC Pregnancy Childbirth. 2021 Aug 17;21(1):559. doi: 10.1186/s12884-021-04040-9.
PubMed 34404382Alnezamy A, Zaineldin A, Ghareib A, Tawfik W, Sabra A, Aboelezz S. Uterine cesarean scar resection during repeat cesarean delivery to prevent uterine niche formation: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 May 4;26(1):489. doi: 10.1186/s12884-026-09142-w.
PubMed 42082941
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Scar Resection During Repeat Cesarean Delivery in a Simple Modification to Prevent Uterine Niche Formation: Results of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07228858
- Acronym / sponsor ID
- RC9-2-2025
- Conditions
- Cesarean Section Complications, Scar Niche, Scarred Uterus
- Keywords
- Repeated cesarean section, Uterine niche, Scar resection, Residual myometrial thickness, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 9 Feb 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Nov 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 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.
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 |
|---|---|---|
| uterine scar resection | Active comparator | Procedure: Repeated cesarean section with previous uterine cesarean section scar resection, Diagnostic Test: Saline-infusion SonohysterographyDuring repeat cesarean section, the previous uterine cesarean section scar was resected. |
| Non scar resection | Active comparator | Procedure: Repeated cesarean section without uterine scar resection, Diagnostic Test: Saline-infusion SonohysterographyStandard repeat cesarean section without previous uterine cesarean section scar resection. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Repeated cesarean section with previous uterine cesarean section scar resectionAfter 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. | Procedure or surgery | uterine scar resection |
| Repeated cesarean section without uterine scar resectionStandard repeat cesarean section without scar resection, followed by double-layer continuous myometrial closure including decidua with visceral peritoneum closure. | Procedure or surgery | Non scar resection |
| Saline-infusion SonohysterographyAt 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. | Diagnostic test | Non scar resection, uterine scar resection |
Primary outcome
Rate of uterine niche formation after repeated cesarean section
Time frame: 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.
5 secondary outcomes
Total operative time.
Time frame: Intraoperative
The mean estimated intraoperative blood loss.
Time frame: Intraoperative
The number of additional hemostatic sutures needed.
Time frame: immediately postoperative
Uterine niche measurments
Time frame: At 6 months postpartum
Menstrual characteristics among participants with uterine niche
Time frame: 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 29 Dec 2025.
- 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 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 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 19499514Osser OV, Jokubkiene L, Valentin L. High prevalence of defects in Cesarean section scars at transvaginal ultrasound examination. Ultrasound Obstet Gynecol. 2009 Jul;34(1):90-7. doi: 10.1002/uog.6395.
- 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 29416572Sholapurkar SL. Etiology of Cesarean Uterine Scar Defect (Niche): Detailed Critical Analysis of Hypotheses and Prevention Strategies and Peritoneal Closure Debate. J Clin Med Res. 2018 Mar;10(3):166-173. doi: 10.14740/jocmr3271w. Epub 2018 Jan 26.
- Results publication: PubMed 34404382Siraj SHM, Lional KM, Tan KH, Wright A. Repair of the myometrial scar defect at repeat caesarean section: a modified surgical technique. BMC Pregnancy Childbirth. 2021 Aug 17;21(1):559. doi: 10.1186/s12884-021-04040-9.
- Derived from this study: PubMed 42082941Alnezamy A, Zaineldin A, Ghareib A, Tawfik W, Sabra A, Aboelezz S. Uterine cesarean scar resection during repeat cesarean delivery to prevent uterine niche formation: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 May 4;26(1):489. doi: 10.1186/s12884-026-09142-w.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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 Repeated cesarean section with previous uterine cesarean section scar resection, Repeated cesarean section without uterine scar resection 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 4 inclusion and 4 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 29 Dec 2025. 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 repeated 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 NCT07228858, 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 29 Dec 2025.