NCT05419804

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

May 30, 2022

Last Update Submit

January 30, 2024

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Medical School

Asyut, 71511, Egypt

Location

Related Publications (10)

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

    PMID: 32839166BACKGROUND

  • 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.

    PMID: 31469990BACKGROUND

  • 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.

    PMID: 31578123BACKGROUND

  • 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.

    PMID: 23466142BACKGROUND

  • 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.

    PMID: 30471891BACKGROUND

  • 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.

    PMID: 32778495BACKGROUND

  • 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.

    PMID: 30142668BACKGROUND

  • 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.

    PMID: 30204620BACKGROUND

  • 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.

    PMID: 31615304BACKGROUND

  • 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.

    PMID: 30486635BACKGROUND

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Officials

  • Ezzat H Sayed, professor

    Assiut medical school

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 30, 2022

First Posted

June 15, 2022

Study Start

June 1, 2022

Primary Completion

July 1, 2023

Study Completion

December 30, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

EG(1)