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

January 8, 2024 updated by: Mahmoud Mohamed Ghaleb, Ain Shams Maternity Hospital

Long-term Follow up of the Cases Who Underwent Conservative Surgery for Placenta Previa Accreta: a Prospective Case Series Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11865
        • Ain Shams University Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Women with one or more previous cesarean deliveries who were diagnosed with placenta previa accreta and underwent Conservative stepwise surgical approach for management in Ain shams maternity hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Easiness of hysteroscopy introduction
Time Frame: 3-6 months
accessibility of hysteroscopic examination
3-6 months
Adequacy of uterine cavity
Time Frame: 3-6 months
visualization of the uterus will be assessed using office hysteroscopy
3-6 months
intrauterine adhesions
Time Frame: 3-6 months
visualization of the intrauterine adhesions will be assessed using office hysteroscopy
3-6 months
cesarean scar niche
Time Frame: 3-6 months
presence of a pouch, that forms on the wall of your uterus.
3-6 months
Menstrual pattern
Time Frame: 3-6 months
menstrual irregularities by history regarding Regular and normal volume or Regular and scanty or presence of Intermenstrual bleeding
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

August 26, 2023

First Submitted That Met QC Criteria

September 1, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hysteroscopic Follow-Up

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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