NCT06105034

Brief Summary

The aim of this study is to identify risk factors associated with performing cesarean hysterectomy versus conservative management in patients with placenta accreta spectrum (PAS). Research question What are the risk factors associated with cesarean hysterectomy in patients with placenta accreta spectrum? Research hypothesis There are certain risk factors associated with cesarean hysterectomy in patients with Placenta accreta spectrum (PAS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 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

Study Start

First participant enrolled

March 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

May 11, 2022

Last Update Submit

November 3, 2023

Conditions

Placenta Accreta

Keywords

placenta accreta spectrum managment

Outcome Measures

Primary Outcomes (1)

  • Number of the patient who diagnosed intraoperative with placenta accreta spectrum disorder and undergoing conservative management or hysterectomy

    The diagnoses will be made based on intra-operative findings and/or pathologic features depending on the degree of placenta invasion (invading the myometrium or invading up to or beyond the uterine serosa). Patients with placenta accreta with complete peri-operative information will be included for further analysis.

    from time of operation to diagnoses 1week

Study Arms (2)

Conservative management

150 patients

Procedure: interventional techniques, the severity of placental invasion, and various placental positions and suture techniques

CS hysterectomy

150 patients

Procedure: interventional techniques, the severity of placental invasion, and various placental positions and suture techniques

Interventions

interventional techniques, the severity of placental invasion, and various placental positions and suture techniquesPROCEDURE

Clinically, severe complications of PA include severe obstetric hemorrhage leading to disseminated intravascular coagulopathy (DIC), iatrogenic injury to the ureters, bladder, bowel, respiratory distress syndrome (RDS), acute transfusion reactions, electrolyte imbalance, and renal failure. In women with PA, the expected blood loss at delivery is 3000- 5000 mL, About 90% of patients require a blood transfusion with 40% requiring more than ten units of packed cell transfusion

CS hysterectomyConservative management

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The aim of this study is to identify risk factors associated with performing cesarean hysterectomy versus conservative management in patients with placenta accreta spectrum (PAS).

You may qualify if:

  • Pregnant women with history of previous cesarean section.
  • Age above 18 years.
  • Gestational age above 28 weeks.
  • Confirmed diagnosis of Placenta previa accreta spectrum disorder by U/S or MRI if needed.
  • U/S signs suggestive of placenta previa accrete (Green-top Guideline).

You may not qualify if:

  • Gestational age less than 28 weeks.
  • Age less than 18years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nourhan Abdelhady Soliman Elsadany

Giza, 267138, Egypt

Location

Related Publications (17)

  • Zeng C, Yang M, Ding Y, Duan S, Zhou Y. Placenta accreta spectrum disorder trends in the context of the universal two-child policy in China and the risk of hysterectomy. Int J Gynaecol Obstet. 2018 Mar;140(3):312-318. doi: 10.1002/ijgo.12418. Epub 2018 Jan 16.

    PMID: 29214633BACKGROUND

  • Yan J, Shi CY, Yu L, Yang HX. Folding Sutures Following Tourniquet Binding as a Conservative Surgical Approach for Placenta Previa Combined with Morbidly Adherent Placenta. Chin Med J (Engl). 2015 Oct 20;128(20):2818-20. doi: 10.4103/0366-6999.167365. No abstract available.

    PMID: 26481753BACKGROUND

  • Wang Q, Ma J, Zhang H, Dou R, Huang B, Wang X, Zhao X, Chen D, Ding Y, Ding H, Cui S, Zhang W, Xin H, Gu W, Hu Y, Ding G, Qi H, Fan L, Ma Y, Lu J, Yang Y, Lin L, Luo X, Zhang X, Fan S, Yang H. Conservative management versus cesarean hysterectomy in patients with placenta increta or percreta. J Matern Fetal Neonatal Med. 2022 May;35(10):1944-1950. doi: 10.1080/14767058.2020.1774871. Epub 2020 Jun 4.

    PMID: 32498575BACKGROUND

  • Thurn L, Lindqvist PG, Jakobsson M, Colmorn LB, Klungsoyr K, Bjarnadottir RI, Tapper AM, Bordahl PE, Gottvall K, Petersen KB, Krebs L, Gissler M, Langhoff-Roos J, Kallen K. Abnormally invasive placenta-prevalence, risk factors and antenatal suspicion: results from a large population-based pregnancy cohort study in the Nordic countries. BJOG. 2016 Jul;123(8):1348-55. doi: 10.1111/1471-0528.13547. Epub 2015 Jul 29.

    PMID: 26227006BACKGROUND

  • Silver 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.

    PMID: 25460838BACKGROUND

  • Silver RM. Abnormal Placentation: Placenta Previa, Vasa Previa, and Placenta Accreta. Obstet Gynecol. 2015 Sep;126(3):654-668. doi: 10.1097/AOG.0000000000001005.

    PMID: 26244528BACKGROUND

  • Sentilhes L, Kayem G, Chandraharan E, Palacios-Jaraquemada J, Jauniaux E; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Conservative management. Int J Gynaecol Obstet. 2018 Mar;140(3):291-298. doi: 10.1002/ijgo.12410. No abstract available.

    PMID: 29405320BACKGROUND

  • Sentilhes L, Goffinet F, Kayem G. Management of placenta accreta. Acta Obstet Gynecol Scand. 2013 Oct;92(10):1125-34. doi: 10.1111/aogs.12222.

    PMID: 23869630BACKGROUND

  • Sentilhes L, Ambroselli C, Kayem G, Provansal M, Fernandez H, Perrotin F, Winer N, Pierre F, Benachi A, Dreyfus M, Bauville E, Mahieu-Caputo D, Marpeau L, Descamps P, Goffinet F, Bretelle F. Maternal outcome after conservative treatment of placenta accreta. Obstet Gynecol. 2010 Mar;115(3):526-534. doi: 10.1097/AOG.0b013e3181d066d4.

    PMID: 20177283BACKGROUND

  • Liu HY, Lin XG, Wu JL, Qiao FY, Deng DR, Zeng WJ. [Multiposition spiral suture of the lower uterine segment: a new technique to control the intraoperative bleeding of pernicious placenta previa]. Zhonghua Fu Chan Ke Za Zhi. 2016 Oct 25;51(10):754-758. doi: 10.3760/cma.j.issn.0529-567X.2016.10.009. Chinese.

    PMID: 27788743BACKGROUND

  • Licon E, Matsuzaki S, Opara KN, Machida H, Roman LD, Sasso EB, Matsuo K. Treatment and outcome of placenta percreta: Primary cesarean hysterectomy versus conservative management. Eur J Obstet Gynecol Reprod Biol. 2020 Jan;244:201-203. doi: 10.1016/j.ejogrb.2019.09.017. Epub 2019 Sep 20. No abstract available.

    PMID: 31627939BACKGROUND

  • Latif Khan Y, Rahim A, Gardezi J, Iqbal M, Hassan Z, Altaf S, Bhatti S. Conventional and conservative management of placenta accreta is two ends of a single continuum: A report of three cases and literature review. Clin Case Rep. 2018 Jul 13;6(9):1739-1746. doi: 10.1002/ccr3.1717. eCollection 2018 Sep.

    PMID: 30214754BACKGROUND

  • Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.

    PMID: 30260097BACKGROUND

  • Hunt JC. Conservative management of placenta accreta in a multiparous woman. J Pregnancy. 2010;2010:329618. doi: 10.1155/2010/329618. Epub 2010 Sep 30.

    PMID: 21490740BACKGROUND

  • 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

  • Bowman ZS, Eller AG, Bardsley TR, Greene T, Varner MW, Silver RM. Risk factors for placenta accreta: a large prospective cohort. Am J Perinatol. 2014 Oct;31(9):799-804. doi: 10.1055/s-0033-1361833. Epub 2013 Dec 12.

    PMID: 24338130BACKGROUND

  • Zhao X, Tao Y, Du Y, Zhao L, Liu C, Zhou Y, Wei P. The application of uterine wall local resection and reconstruction to preserve the uterus for the management of morbidly adherent placenta: Case series. Taiwan J Obstet Gynecol. 2018 Apr;57(2):276-282. doi: 10.1016/j.tjog.2018.02.017.

    PMID: 29673673RESULT

MeSH Terms

Conditions

Placenta Accreta

Interventions

Suture Techniques

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Intervention Hierarchy (Ancestors)

Wound Closure TechniquesSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
sponsor investigator

Study Record Dates

First Submitted

May 11, 2022

First Posted

October 27, 2023

Study Start

March 1, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

EG(1)