Placenta Accreta; Total Lower Uterine Segmentectomy With Cervico-corporeal Anastomosis

Placenta Accreta Clinical Trial

Official title:

Placenta Accreta; Total Lower Uterine Segmentectomy With Cervico-corporeal Anastomosis, a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05419804
• Other study ID #: TLUSCCA
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To study feasibility and safety of Total lower uterine segmentectomy with cervico-corporeal anastomosis in conservative management of placenta accreta

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 30, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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 .

Related Conditions & MeSH terms

• Placenta Accreta

Locations

Country	Name	City	State
Egypt	Assiut Medical School	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

Abo-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. — View Citation

Biyik 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. — View Citation

Bloomfield V, Rogers S, Leyland N. Placenta accreta spectrum. CMAJ. 2020 Aug 24;192(34):E980. doi: 10.1503/cmaj.200304. No abstract available. — View Citation

Di 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. — View Citation

Fonseca 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. — View Citation

Haunschild 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. — View Citation

Pinas 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. — View Citation

Society 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. — View Citation

Wortman 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. — View Citation

Zuckerwise 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1year