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

Placenta Accreta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06029985
• Other study ID #: Hysteroscopic Follow-Up
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2024
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: December 1, 2020
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Previa

Intervention

Diagnostic Test:
• Hysteroscopic Follow Up
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.

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

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