Hysteroscopic Follow-up Following Conservative Stepwise Surgical Approach for Management of Placenta Previa Accreta

Sponsor
Ain Shams Maternity Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06029985
Collaborator
(none)
50
1
13
3.8

Study Details

Study Description

Brief Summary

Conservative management of placenta accreta spectrum can preserve future fertility but should only be done in hospitals with enough experience as it carries a high risk of maternal complications.

Follow up after conservative management is crucial to detect complications early.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Hysteroscopic Follow Up

Detailed Description

Placenta accreta is defined histopathologically as abnormal trophoblast invasion of part or all of the placenta into the myometrium of the uterine wall.1 Depending on the depth of villous tissue invasiveness, placenta accreta was subdivided by pathologists into "creta", "increta", and "percreta", in which the villi adhere superficially to the myometrium without interposing decidua, penetrate deeply into the uterine myometrium, and perforate through the entire uterine wall and may invade the surrounding pelvic organs, respectively.

The term placenta accreta spectrum (PAS) will be used in this manuscript to include both the abnormally adherent and the invasive forms of accreta placentation. Severe and sometimes life-threatening hemorrhage, which often requires blood transfusion, increases maternal morbidity and mortality.

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Hysteroscopic Follow up Following Conservative Stepwise Surgical Approach for Management of Placenta Previa Accreta
Actual Study Start Date :
Dec 1, 2019
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 31, 2020

Outcome Measures

Primary Outcome Measures

  1. Easiness of hysteroscopy introduction [3-6 months]

    accessibility of hysteroscopic examination

  2. Adequacy of uterine cavity [3-6 months]

    visualization of the uterus will be assessed using office hysteroscopy

  3. intrauterine adhesions [3-6 months]

    visualization of the intrauterine adhesions will be assessed using office hysteroscopy

  4. cesarean scar niche [3-6 months]

    presence of a pouch, that forms on the wall of your uterus.

  5. Menstrual pattern [3-6 months]

    menstrual irregularities by history regarding Regular and normal volume or Regular and scanty or presence of Intermenstrual bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:
  1. Pregnant women with one or more previous cesarean deliveries

  2. Women diagnosed with placenta previa accreta and underwent Conservative stepwise surgical approach for management.

Exclusion Criteria:
  1. women who refused to participate in the study.

  2. Associated other medical conditions as pregnancy-induced hypertension, heart diseases, and rheumatological diseases apart from iron deficiency anemia.

  3. Presence of uterine anomalies

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain Shams University Maternity Hospital Cairo Egypt 11865

Sponsors and Collaborators

  • Ain Shams Maternity Hospital

Investigators

  • Study Director: Mohamed Samy, MD, Ain Shams Maternity Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahmoud Mohamed Ghaleb, Professor, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier:
NCT06029985
Other Study ID Numbers:
  • Hysteroscopic Follow-Up
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 8, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2023