Placenta AccretaNCT05419804
Placenta Accreta; Total Lower Uterine Segmentectomy With Cervico-corporeal Anastomosis
An observational study of Placenta Accreta, run by Assiut University at 1 site in Egypt.
Trial summary
To study feasibility and safety of Total lower uterine segmentectomy with cervico-corporeal anastomosis in conservative management of placenta accreta Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Placenta Accreta
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 30 Dec 2023
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: pregnant women diagnosed with placenta accreta by us and Doppler Accreta invading the entire or most of the lus Women who welling uterine conservation, planned and elective cs for women diagnosed with accreta, and accepting participation
Who may be able to join
- pregnant women diagnosed with placenta accreta by us and Doppler Accreta invading the entire or most of the lus Women who welling uterine conservation, Planned and elective cs for women diagnosed with accreta, and accepting participation
Who cannot join
- women who don't accept participation, women who desire hysterectomy. Women who diagnosed with accrete and placenta separated easily women with concomitant pathology and requiring hysterectomy .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placenta Accreta; Total Lower Uterine Segmentectomy With Cervico-corporeal Anastomosis, a Feasibility Study
To study feasibility and safety of Total lower uterine segmentectomy with cervico-corporeal anastomosis in conservative management of placenta accreta
Read the detailed description
Placenta accreta represents a real challenge in modern obstetric care as its incidence is increasing in a parallelism with increased CSs rates. Its management represents another challenge and a multidisciplinary team with clear plans and alternative strategies that fulfill different situation and address different patient needs must be clearly settled in every referral center dealing with placenta accreta.
Hysterectomy without trials of placental separation seems to be the standard and logical procedure. However hysterectomy needs to be a total or at least including the entire invaded Lower uterine segment. Hysterectomy is associated with significant blood loss, and loss of future fertility. There are several fertility conservation approaches with variable success rates, complications, technical demands and costs.
Uterine plication sutures has been reported as successful uterine conservation strategy but subsequent intrauterine adhesions, weak uterine scar and uterine necrosis might culminate in a functionless uterus.
The present work describes total lower uterine segmentectomy with cervical-corporeal anastomosis as a relatively less invasive uterine conservation strategy with minimization of blood loss and transfusion needs. Furthermore, total lower uterine segmentectomy with cervico-corporeal anastomosis has the merits of leaving behind a strong scar and a well-functioning uterus.
- Conditions
- Placenta Accreta
- Medical subject headings
- Placenta Accreta
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of procedure
Success of procedure regarding ability to preserve the uterus and stoppage of bleeding.
The bleeding will be evaluated by haemoglobin level preoperative and postoperative.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Jun 2022
- Primary completion1 Jul 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Mohamed, Assiut University
- Investigators
- Ezzat H Sayed, professor, Study chair, Assiut medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419804
- Sponsor's protocol ID
- TLUSCCA
- Status last verified
- Jan 2024
- First submitted
- 30 May 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bloomfield V, Rogers S, Leyland N. Placenta accreta spectrum. CMAJ. 2020 Aug 24;192(34):E980. doi: 10.1503/cmaj.200304. No abstract available.
PubMed 32839166Zuckerwise LC, Craig AM, Newton JM, Zhao S, Bennett KA, Crispens MA. Outcomes following a clinical algorithm allowing for delayed hysterectomy in the management of severe placenta accreta spectrum. Am J Obstet Gynecol. 2020 Feb;222(2):179.e1-179.e9. doi: 10.1016/j.ajog.2019.08.035. Epub 2019 Aug 27.
PubMed 31469990Pinas Carrillo A, Chandraharan E. Placenta accreta spectrum: Risk factors, diagnosis and management with special reference to the Triple P procedure. Womens Health (Lond). 2019 Jan-Dec;15:1745506519878081. doi: 10.1177/1745506519878081.
PubMed 31578123Wortman AC, Alexander JM. Placenta accreta, increta, and percreta. Obstet Gynecol Clin North Am. 2013 Mar;40(1):137-54. doi: 10.1016/j.ogc.2012.12.002.
PubMed 23466142Society of Gynecologic Oncology; American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine; Cahill AG, Beigi R, Heine RP, Silver RM, Wax JR. Placenta Accreta Spectrum. Am J Obstet Gynecol. 2018 Dec;219(6):B2-B16. doi: 10.1016/j.ajog.2018.09.042.
PubMed 30471891Fonseca A, Ayres de Campos D. Maternal morbidity and mortality due to placenta accreta spectrum disorders. Best Pract Res Clin Obstet Gynaecol. 2021 Apr;72:84-91. doi: 10.1016/j.bpobgyn.2020.07.011. Epub 2020 Jul 20.
PubMed 32778495Biyik I, Keskin F, Keskin EU. Conservative Surgical Treatment of a Case of Placenta Accreta. Rev Bras Ginecol Obstet. 2018 Aug;40(8):494-496. doi: 10.1055/s-0038-1668528. Epub 2018 Aug 24.
PubMed 30142668Haunschild C, Yeaton-Massey A, Lyell DJ. Antenatal Management of Placenta Accreta. Clin Obstet Gynecol. 2018 Dec;61(4):766-773. doi: 10.1097/GRF.0000000000000394.
PubMed 30204620Abo-Elroose AA, Ahmed MR, Shaaban MM, Ghoneim HM, Mohamed TY. Triple P with T-shaped lower segment suture; an effective novel alternative to hysterectomy in morbidly adherent anterior placenta previa. J Matern Fetal Neonatal Med. 2021 Oct;34(19):3187-3191. doi: 10.1080/14767058.2019.1678145. Epub 2019 Oct 15.
PubMed 31615304Di Mascio D, Cali G, D'antonio F. Updates on the management of placenta accreta spectrum. Minerva Ginecol. 2019 Apr;71(2):113-120. doi: 10.23736/S0026-4784.18.04333-2. Epub 2018 Nov 27.
PubMed 30486635
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placenta Accreta; Total Lower Uterine Segmentectomy With Cervico-corporeal Anastomosis, a Feasibility Study
- ClinicalTrials.gov ID
- NCT05419804
- Acronym / sponsor ID
- TLUSCCA
- Conditions
- Placenta Accreta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 15 Jun 2022 (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.
To study feasibility and safety of Total lower uterine segmentectomy with cervico-corporeal anastomosis in conservative management of placenta accreta
Detailed description
Placenta accreta represents a real challenge in modern obstetric care as its incidence is increasing in a parallelism with increased CSs rates. Its management represents another challenge and a multidisciplinary team with clear plans and alternative strategies that fulfill different situation and address different patient needs must be clearly settled in every referral center dealing with placenta accreta.
Hysterectomy without trials of placental separation seems to be the standard and logical procedure. However hysterectomy needs to be a total or at least including the entire invaded Lower uterine segment. Hysterectomy is associated with significant blood loss, and loss of future fertility. There are several fertility conservation approaches with variable success rates, complications, technical demands and costs.
Uterine plication sutures has been reported as successful uterine conservation strategy but subsequent intrauterine adhesions, weak uterine scar and uterine necrosis might culminate in a functionless uterus.
The present work describes total lower uterine segmentectomy with cervical-corporeal anastomosis as a relatively less invasive uterine conservation strategy with minimization of blood loss and transfusion needs. Furthermore, total lower uterine segmentectomy with cervico-corporeal anastomosis has the merits of leaving behind a strong scar and a well-functioning uterus.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant women diagnosed with placenta accreta by us and Doppler Accreta invading the entire or most of the lus Women who welling uterine conservation, planned and elective cs for women diagnosed with accreta, and accepting participation
Key inclusion criteria (1 listed)
- pregnant women diagnosed with placenta accreta by us and Doppler Accreta invading the entire or most of the lus Women who welling uterine conservation, Planned and elective cs for women diagnosed with accreta, and accepting participation
Key exclusion criteria (1 listed)
- women who don't accept participation, women who desire hysterectomy. Women who diagnosed with accrete and placenta separated easily women with concomitant pathology and requiring hysterectomy .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Success of procedure
Time frame: 1year
Success of procedure regarding ability to preserve the uterus and stoppage of bleeding. The bleeding will be evaluated by haemoglobin level preoperative and postoperative.
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 31 Jan 2024.
- Background: PubMed 32839166Bloomfield V, Rogers S, Leyland N. Placenta accreta spectrum. CMAJ. 2020 Aug 24;192(34):E980. doi: 10.1503/cmaj.200304. No abstract available.
- Background: PubMed 31469990Zuckerwise LC, Craig AM, Newton JM, Zhao S, Bennett KA, Crispens MA. Outcomes following a clinical algorithm allowing for delayed hysterectomy in the management of severe placenta accreta spectrum. Am J Obstet Gynecol. 2020 Feb;222(2):179.e1-179.e9. doi: 10.1016/j.ajog.2019.08.035. Epub 2019 Aug 27.
- Background: PubMed 31578123Pinas Carrillo A, Chandraharan E. Placenta accreta spectrum: Risk factors, diagnosis and management with special reference to the Triple P procedure. Womens Health (Lond). 2019 Jan-Dec;15:1745506519878081. doi: 10.1177/1745506519878081.
- Background: PubMed 23466142Wortman AC, Alexander JM. Placenta accreta, increta, and percreta. Obstet Gynecol Clin North Am. 2013 Mar;40(1):137-54. doi: 10.1016/j.ogc.2012.12.002.
- Background: PubMed 30471891Society of Gynecologic Oncology; American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine; Cahill AG, Beigi R, Heine RP, Silver RM, Wax JR. Placenta Accreta Spectrum. Am J Obstet Gynecol. 2018 Dec;219(6):B2-B16. doi: 10.1016/j.ajog.2018.09.042.
- Background: PubMed 32778495Fonseca A, Ayres de Campos D. Maternal morbidity and mortality due to placenta accreta spectrum disorders. Best Pract Res Clin Obstet Gynaecol. 2021 Apr;72:84-91. doi: 10.1016/j.bpobgyn.2020.07.011. Epub 2020 Jul 20.
- Background: PubMed 30142668Biyik I, Keskin F, Keskin EU. Conservative Surgical Treatment of a Case of Placenta Accreta. Rev Bras Ginecol Obstet. 2018 Aug;40(8):494-496. doi: 10.1055/s-0038-1668528. Epub 2018 Aug 24.
- Background: PubMed 30204620Haunschild C, Yeaton-Massey A, Lyell DJ. Antenatal Management of Placenta Accreta. Clin Obstet Gynecol. 2018 Dec;61(4):766-773. doi: 10.1097/GRF.0000000000000394.
- Background: PubMed 31615304Abo-Elroose AA, Ahmed MR, Shaaban MM, Ghoneim HM, Mohamed TY. Triple P with T-shaped lower segment suture; an effective novel alternative to hysterectomy in morbidly adherent anterior placenta previa. J Matern Fetal Neonatal Med. 2021 Oct;34(19):3187-3191. doi: 10.1080/14767058.2019.1678145. Epub 2019 Oct 15.
- Background: PubMed 30486635Di Mascio D, Cali G, D'antonio F. Updates on the management of placenta accreta spectrum. Minerva Ginecol. 2019 Apr;71(2):113-120. doi: 10.23736/S0026-4784.18.04333-2. Epub 2018 Nov 27.
- Individual participant dataSharing planned: Undecided
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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.
Ezzat H Sayed, professor study chair
Assiut medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta, run by Assiut 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 1 inclusion and 1 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 31 Jan 2024. 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?
Success of procedure (time frame: 1year). 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 NCT05419804, which also lists 10 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 31 Jan 2024.