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Completed

NCT Number: NCT06029985

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

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.

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Key information

Conditions

Placenta Accreta Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Ain Shams University Maternity Hospital

Cairo, 11865, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women with one or more previous cesarean deliveries
  • Women diagnosed with placenta previa accreta and underwent Conservative stepwise surgical approach for management.

Exclusion criteria

  • women who refused to participate in the study.
  • Associated other medical conditions as pregnancy-induced hypertension, heart diseases, and rheumatological diseases apart from iron deficiency anemia.
  • Presence of uterine anomalies

Treatment and study plan

Hysteroscopic Follow Up

Diagnostic Test

Office hysteroscopy was carried out to detect the scar site, performed with a 4-mm, continuous-flow operative hysteroscope by vaginoscopic approach, without analgesia or anesthesia. Distension of the uterus was obtained using a normal solution as distension medium, dispensed by an electronic suction/irrigation pump. This can maintain a constant intrauterine pressure of around 30-40 mmHg, balancing an irrigation flow of 200 mL/min with a vacuum of 0.2 bars, necessary to avoid overdistension of the muscle fibers and patient discomfort. The use of this distension medium allows blood or mucus to be washed out from the pouch if necessary.

Primary outcomes

  1. Easiness of hysteroscopy introduction

    Time frame: 3-6 months

    accessibility of hysteroscopic examination

  2. Adequacy of uterine cavity

    Time frame: 3-6 months

    visualization of the uterus will be assessed using office hysteroscopy

  3. intrauterine adhesions

    Time frame: 3-6 months

    visualization of the intrauterine adhesions will be assessed using office hysteroscopy

  4. cesarean scar niche

    Time frame: 3-6 months

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

  5. 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

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 8, 2023
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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