Placenta Accreta SpectrumHISEALNCT06620432
High vs. Low Segmental Hysterotomy: Impact on Uterine Wall Defects Post-Cesarean
A study testing Low segment hysterotomy, High segment hysterotomy and Crossed hysterorrhaphy in people with Placenta Accreta Spectrum, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
Trial summary
The purpose of this clinical trial is to compare the incidence of defects in the uterine wall at the site of the scar (niche) and surgical complications when using high-segment versus low-segment hysterotomy, with both cross-suturing and non-cross-suturing techniques, in pregnant patients undergoing their first… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta Spectrum
- What is being tested?
- Low segment hysterotomy, High segment hysterotomy and Crossed hysterorrhaphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteColombia
- Study dates
- 12 Jun 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women aged ≥ 18 years.
- Confirmed pregnancy through clinical history or ultrasound between 36 and 42 weeks of gestation.
- Indication by the attending gynecologist for a first cesarean section, either emergent or elective.
Who cannot join
- History of myometrial intervention, such as myomectomy.
- History of genetic or acquired conditions that alter the anatomy of the uterus.
- History of coagulation disorders.
- History of connective tissue disorders, such as Lupus and Scleroderma, which may affect healing.
- Hemodynamically unstable patients due to a clinical condition prior to performing the cesarean section.
- Failure to sign the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Fundación Valle del Lili
Cali, Valle del Cauca Department, 760032
Albaro J. Nieto, M.D. PhD, 3319090 ext. 4022, albaro.nieto@fvl.org.co
José M. Palacios, PhD
About this study
Official title: High Segmental Hysterotomy vs. Low Segmental Hysterotomy: Association With the Incidence of Uterine Wall Defects After Cesarean Section
The purpose of this clinical trial is to compare the incidence of defects in the uterine wall at the site of the scar (niche) and surgical complications when using high-segment versus low-segment hysterotomy, with both cross-suturing and non-cross-suturing techniques, in pregnant patients undergoing their first cesarean section.
Researchers will compare four arms:
Read more
- Low Segment Hysterotomy + Crossed hysterorrhaphy
- High Segment Hysterotomy + Crossed hysterorrhaphy
- Low Segment Hysterotomy + Non-Crossed hysterorrhaphy
- High Segment Hysterotomy + Non-Crossed hysterorrhaphy
Participants will:
- Cesarean delivery
- Attend a follow up appointment between 6 to 16 weeks post surgery where will be perform a transvaginal sonography.
Read the detailed description
This study will be conducted as a single-blind trial. Patients will be approached in the delivery room, where a comprehensive review of the inclusion and exclusion criteria checklist will be conducted to determine their eligibility for the study. Once eligible patients are identified, the study will be thoroughly explained to them, highlighting its purpose, potential benefits, and risks. This will be followed by a detailed discussion of the informed consent form to ensure that participants fully understand what their involvement entails.
Upon obtaining informed consent, a randomization process will be implemented to allocate participants to one of the four study arms. The assigned procedure will be performed by their attending gynecologist, who is familiar with their medical history and care needs. Throughout the study, various outcomes will be measured, including intraoperative findings, postoperative recovery, and post-discharge progress.
A transvaginal pelvic ultrasound will be ordered to be performed between 6 and 16 weeks postoperatively. During the single follow-up appointment, this imaging evaluation will be carried out to determine the presence or absence of an isthmocele, as well as to assess its characteristics, such as size and location, if present.
- Conditions
- Placenta Accreta Spectrum
- Being tested
- Low segment hysterotomy, High segment hysterotomy, Crossed hysterorrhaphy, Non-Crossed hysterorrhaphy
- Keywords
- High segmental hysterotomy, Low segmental hysterotomy, Caesarean section, hysterotomy defects
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low segment hysterotomyProcedure or surgery
A low segment hysterotomy is a surgical procedure in which an incision is made in the lower segment of the uterus, typically during a cesarean section or other uterine surgeries. This approach is preferred because the lower uterine segment is thinner and less vascular, reducing the risk of bleeding and complications during and after the procedure. The incision is typically horizontal.
High segment hysterotomyProcedure or surgery
A high segment hysterotomy is a surgical procedure involving an incision in the upper segment of the uterus.
Crossed hysterorrhaphyProcedure or surgery
Crossed hysterorrhaphy is a surgical technique used to close the uterine incision following a hysterotomy, particularly during cesarean sections. In this method, the sutures are placed in a crossed or X-shaped pattern, which helps to evenly distribute tension across the incision site.
Non-Crossed hysterorrhaphyProcedure or surgery
Non-crossed hysterorrhaphy is a surgical technique used to close a uterine incision, typically after a hysterotomy, such as during a cesarean section. In this method, the sutures are placed in a linear, parallel fashion rather than in a crossed or X-shaped pattern
| Study group | Role | What they receive |
|---|---|---|
| Low Segment Hysterotomy + Crossed hysterorrhaphy | Active comparator | The participant will undergo a cesarean section in which the surgical technique of Low Segment Hysterotomy and Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist. Receives: Procedure: Low segment hysterotomy; Procedure: Crossed hysterorrhaphy |
| High Segment Hysterotomy + Crossed hysterorrhaphy | Experimental | The participant will undergo a cesarean section in which the surgical technique of High Segment Hysterotomy and Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist. Receives: Procedure: High segment hysterotomy; Procedure: Crossed hysterorrhaphy |
| Low Segment Hysterotomy + Non-Crossed hysterorrhaphy | Experimental | The participant will undergo a cesarean section in which the surgical technique of Low Segment Hysterotomy and Non-Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist. Receives: Procedure: Low segment hysterotomy; Procedure: Non-Crossed hysterorrhaphy |
| High Segment Hysterotomy + Non-Crossed hysterorrhaphy | Experimental | The participant will undergo a cesarean section in which the surgical technique of High Segment Hysterotomy and Non-Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist. Receives: Procedure: High segment hysterotomy; Procedure: Non-Crossed hysterorrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of uterine wall defect at the scar site
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
Measured: 6 to 16 weeks post-hysterotomy
Secondary outcomes (5)
Residual myometrial thickness of the uterine wall defect at the scar site
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
Measured: 6 to 16 weeks post-hysterotomy
Myometrial thickness in the portion immediately cephalad to the residual myometrial defect
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
Measured: 6 to 16 weeks post-hysterotomy
Myometrial thickness in the portion immediately caudal to the residual myometrial defect
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
Measured: 6 to 16 weeks post-hysterotomy
Size of the uterine wall defect
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
Measured: 6 to 16 weeks post-hysterotomy
Depth of the defect in the uterine wall
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
Measured: 6 to 16 weeks post-hysterotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start12 Jun 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Placenta Accreta SpectrumStudies of the same condition, open and under way.
- 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
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albaro J. Nieto, M.D., Principal investigator, Fundacion Clinica Valle del Lili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620432
- Sponsor's protocol ID
- 2024.079
- Acronym
- HISEAL
- Status last verified
- May 2026
- First submitted
- 26 Aug 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared, as disclosure of information related to the medical history of participants or health care workers is not permitted under applicable regulations.
Publications
Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
PubMed 26849801Buca D, Liberati M, Cali G, Forlani F, Caisutti C, Flacco ME, Manzoli L, Familiari A, Scambia G, D'Antonio F. Influence of prenatal diagnosis of abnormally invasive placenta on maternal outcome: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Sep;52(3):304-309. doi: 10.1002/uog.19070. Epub 2018 Jul 29.
PubMed 29660186Silver RM, Fox KA, Barton JR, Abuhamad AZ, Simhan H, Huls CK, Belfort MA, Wright JD. Center of excellence for placenta accreta. Am J Obstet Gynecol. 2015 May;212(5):561-8. doi: 10.1016/j.ajog.2014.11.018. Epub 2014 Nov 20.
PubMed 25460838Palacios-Jaraquemada JM. Placental adhesive disorders, 1st ed. Berlin: DeGruyter editors, 2012 161 pages. ISBN 978-3-11-028238-2.
Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24.
PubMed 28599899Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Sep 25.
PubMed 26409016Fabres C, Aviles G, De La Jara C, Escalona J, Munoz JF, Mackenna A, Fernandez C, Zegers-Hochschild F, Fernandez E. The cesarean delivery scar pouch: clinical implications and diagnostic correlation between transvaginal sonography and hysteroscopy. J Ultrasound Med. 2003 Jul;22(7):695-700; quiz 701-2. doi: 10.7863/jum.2003.22.7.695.
PubMed 12862268Kremer TG, Ghiorzi IB, Dibi RP. Isthmocele: an overview of diagnosis and treatment. Rev Assoc Med Bras (1992). 2019 Jun 3;65(5):714-721. doi: 10.1590/1806-9282.65.5.714.
PubMed 31166450Sung S, Mikes BA, Martingano DJ, Mahdy H. Cesarean Delivery. 2024 Dec 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK546707/
PubMed 31536313Dodd JM, Anderson ER, Gates S, Grivell RM. Surgical techniques for uterine incision and uterine closure at the time of caesarean section. Cochrane Database Syst Rev. 2014 Jul 22;2014(7):CD004732. doi: 10.1002/14651858.CD004732.pub3.
PubMed 25048608Cunningham FG, Larry C Gilstrap III, Hauth JC, Leveno KJ, Wenstrom KD, Gant NF. Obstetricia de Williams. Editorial Mac Graw Hill; 2019.
Shao Y, Pradhan M. Higher Incision at Upper Part of Lower Segment Caesarean Section. JNMA J Nepal Med Assoc. 2014 Apr-Jun;52(194):764-70.
PubMed 26905701Armstrong F, Mulligan K, Dermott RM, Bartels HC, Carroll S, Robson M, Corcoran S, Parland PM, Brien DO, Brophy D, Brennan DJ. Cesarean scar niche: An evolving concern in clinical practice. Int J Gynaecol Obstet. 2023 May;161(2):356-366. doi: 10.1002/ijgo.14509. Epub 2022 Nov 21.
PubMed 36317541Monteagudo 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 11587017Hofmeyr GJ, Mathai M, Shah A, Novikova N. Techniques for caesarean section. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD004662. doi: 10.1002/14651858.CD004662.pub2.
PubMed 18254057
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Segmental Hysterotomy vs. Low Segmental Hysterotomy: Association With the Incidence of Uterine Wall Defects After Cesarean Section
- ClinicalTrials.gov ID
- NCT06620432
- Acronym / sponsor ID
- HISEAL / 2024.079
- Conditions
- Placenta Accreta Spectrum
- Keywords
- High segmental hysterotomy, Low segmental hysterotomy, Caesarean section, hysterotomy defects
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Fundacion Clinica Valle del LiliUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 1 Oct 2024 (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 this clinical trial is to compare the incidence of defects in the uterine wall at the site of the scar (niche) and surgical complications when using high-segment versus low-segment hysterotomy, with both cross-suturing and non-cross-suturing techniques, in pregnant patients undergoing their first cesarean section.
Researchers will compare four arms:
- Low Segment Hysterotomy + Crossed hysterorrhaphy
- High Segment Hysterotomy + Crossed hysterorrhaphy
- Low Segment Hysterotomy + Non-Crossed hysterorrhaphy
- High Segment Hysterotomy + Non-Crossed hysterorrhaphy
Participants will:
- Cesarean delivery
- Attend a follow up appointment between 6 to 16 weeks post surgery where will be perform a transvaginal sonography.
Detailed description
This study will be conducted as a single-blind trial. Patients will be approached in the delivery room, where a comprehensive review of the inclusion and exclusion criteria checklist will be conducted to determine their eligibility for the study. Once eligible patients are identified, the study will be thoroughly explained to them, highlighting its purpose, potential benefits, and risks. This will be followed by a detailed discussion of the informed consent form to ensure that participants fully understand what their involvement entails.
Upon obtaining informed consent, a randomization process will be implemented to allocate participants to one of the four study arms. The assigned procedure will be performed by their attending gynecologist, who is familiar with their medical history and care needs. Throughout the study, various outcomes will be measured, including intraoperative findings, postoperative recovery, and post-discharge progress.
A transvaginal pelvic ultrasound will be ordered to be performed between 6 and 16 weeks postoperatively. During the single follow-up appointment, this imaging evaluation will be carried out to determine the presence or absence of an isthmocele, as well as to assess its characteristics, such as size and location, if present.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Segment Hysterotomy + Crossed hysterorrhaphy | Active comparator | Procedure: Low segment hysterotomy, Procedure: Crossed hysterorrhaphyThe participant will undergo a cesarean section in which the surgical technique of Low Segment Hysterotomy and Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist. |
| High Segment Hysterotomy + Crossed hysterorrhaphy | Experimental | Procedure: High segment hysterotomy, Procedure: Crossed hysterorrhaphyThe participant will undergo a cesarean section in which the surgical technique of High Segment Hysterotomy and Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist. |
| Low Segment Hysterotomy + Non-Crossed hysterorrhaphy | Experimental | Procedure: Low segment hysterotomy, Procedure: Non-Crossed hysterorrhaphyThe participant will undergo a cesarean section in which the surgical technique of Low Segment Hysterotomy and Non-Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist. |
| High Segment Hysterotomy + Non-Crossed hysterorrhaphy | Experimental | Procedure: High segment hysterotomy, Procedure: Non-Crossed hysterorrhaphyThe participant will undergo a cesarean section in which the surgical technique of High Segment Hysterotomy and Non-Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women aged ≥ 18 years.
- Confirmed pregnancy through clinical history or ultrasound between 36 and 42 weeks of gestation.
- Indication by the attending gynecologist for a first cesarean section, either emergent or elective.
Key exclusion criteria (6 listed)
- History of myometrial intervention, such as myomectomy.
- History of genetic or acquired conditions that alter the anatomy of the uterus.
- History of coagulation disorders.
- History of connective tissue disorders, such as Lupus and Scleroderma, which may affect healing.
- Hemodynamically unstable patients due to a clinical condition prior to performing the cesarean section.
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 |
|---|---|---|
| Low segment hysterotomyA low segment hysterotomy is a surgical procedure in which an incision is made in the lower segment of the uterus, typically during a cesarean section or other uterine surgeries. This approach is preferred because the lower uterine segment is thinner and less vascular, reducing the risk of bleeding and complications during and after the procedure. The incision is typically horizontal. | Procedure or surgery | Low Segment Hysterotomy + Crossed hysterorrhaphy, Low Segment Hysterotomy + Non-Crossed hysterorrhaphy |
| High segment hysterotomyA high segment hysterotomy is a surgical procedure involving an incision in the upper segment of the uterus. | Procedure or surgery | High Segment Hysterotomy + Crossed hysterorrhaphy, High Segment Hysterotomy + Non-Crossed hysterorrhaphy |
| Crossed hysterorrhaphyCrossed hysterorrhaphy is a surgical technique used to close the uterine incision following a hysterotomy, particularly during cesarean sections. In this method, the sutures are placed in a crossed or X-shaped pattern, which helps to evenly distribute tension across the incision site. | Procedure or surgery | High Segment Hysterotomy + Crossed hysterorrhaphy, Low Segment Hysterotomy + Crossed hysterorrhaphy |
| Non-Crossed hysterorrhaphyNon-crossed hysterorrhaphy is a surgical technique used to close a uterine incision, typically after a hysterotomy, such as during a cesarean section. In this method, the sutures are placed in a linear, parallel fashion rather than in a crossed or X-shaped pattern | Procedure or surgery | High Segment Hysterotomy + Non-Crossed hysterorrhaphy, Low Segment Hysterotomy + Non-Crossed hysterorrhaphy |
Primary outcome
Incidence of uterine wall defect at the scar site
Time frame: 6 to 16 weeks post-hysterotomy
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
5 secondary outcomes
Residual myometrial thickness of the uterine wall defect at the scar site
Time frame: 6 to 16 weeks post-hysterotomy
Myometrial thickness in the portion immediately cephalad to the residual myometrial defect
Time frame: 6 to 16 weeks post-hysterotomy
Myometrial thickness in the portion immediately caudal to the residual myometrial defect
Time frame: 6 to 16 weeks post-hysterotomy
Size of the uterine wall defect
Time frame: 6 to 16 weeks post-hysterotomy
Depth of the defect in the uterine wall
Time frame: 6 to 16 weeks post-hysterotomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 26849801Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
- Background: PubMed 29660186Buca D, Liberati M, Cali G, Forlani F, Caisutti C, Flacco ME, Manzoli L, Familiari A, Scambia G, D'Antonio F. Influence of prenatal diagnosis of abnormally invasive placenta on maternal outcome: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Sep;52(3):304-309. doi: 10.1002/uog.19070. Epub 2018 Jul 29.
- Background: PubMed 25460838Silver RM, Fox KA, Barton JR, Abuhamad AZ, Simhan H, Huls CK, Belfort MA, Wright JD. Center of excellence for placenta accreta. Am J Obstet Gynecol. 2015 May;212(5):561-8. doi: 10.1016/j.ajog.2014.11.018. Epub 2014 Nov 20.
- BackgroundPalacios-Jaraquemada JM. Placental adhesive disorders, 1st ed. Berlin: DeGruyter editors, 2012 161 pages. ISBN 978-3-11-028238-2.
- Background: PubMed 28599899Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24.
- Background: PubMed 26409016Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Sep 25.
- Background: PubMed 12862268Fabres C, Aviles G, De La Jara C, Escalona J, Munoz JF, Mackenna A, Fernandez C, Zegers-Hochschild F, Fernandez E. The cesarean delivery scar pouch: clinical implications and diagnostic correlation between transvaginal sonography and hysteroscopy. J Ultrasound Med. 2003 Jul;22(7):695-700; quiz 701-2. doi: 10.7863/jum.2003.22.7.695.
- Background: PubMed 31166450Kremer TG, Ghiorzi IB, Dibi RP. Isthmocele: an overview of diagnosis and treatment. Rev Assoc Med Bras (1992). 2019 Jun 3;65(5):714-721. doi: 10.1590/1806-9282.65.5.714.
- Background: PubMed 31536313Sung S, Mikes BA, Martingano DJ, Mahdy H. Cesarean Delivery. 2024 Dec 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK546707/
- Background: PubMed 25048608Dodd JM, Anderson ER, Gates S, Grivell RM. Surgical techniques for uterine incision and uterine closure at the time of caesarean section. Cochrane Database Syst Rev. 2014 Jul 22;2014(7):CD004732. doi: 10.1002/14651858.CD004732.pub3.
- BackgroundCunningham FG, Larry C Gilstrap III, Hauth JC, Leveno KJ, Wenstrom KD, Gant NF. Obstetricia de Williams. Editorial Mac Graw Hill; 2019.
- Background: PubMed 26905701Shao Y, Pradhan M. Higher Incision at Upper Part of Lower Segment Caesarean Section. JNMA J Nepal Med Assoc. 2014 Apr-Jun;52(194):764-70.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared, as disclosure of information related to the medical history of participants or health care workers is not permitted under applicable regulations.
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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.
Albaro J. Nieto, M.D. principal investigator
Fundacion Clinica Valle del Lili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low segment hysterotomy, High segment hysterotomy and Crossed hysterorrhaphy in people with Placenta Accreta Spectrum, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 7 May 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 Colombia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albaro J. Nieto, M.D. (3319090 ext. 4022, albaro.nieto@fvl.org.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of uterine wall defect at the scar site (time frame: 6 to 16 weeks post-hysterotomy). 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 NCT06620432, which also lists 35 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 7 May 2026.