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

NCT06029985 | Completed

• 1 other identifier: Hysteroscopic Follow-Up
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (5)

• Easiness of hysteroscopy introduction

  accessibility of hysteroscopic examination

  3-6 months

• Adequacy of uterine cavity

  visualization of the uterus will be assessed using office hysteroscopy

  3-6 months

• intrauterine adhesions

  visualization of the intrauterine adhesions will be assessed using office hysteroscopy

  3-6 months

• cesarean scar niche

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

  3-6 months

• Menstrual pattern

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

  3-6 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, 11865, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohamed Samy, MD

  Ain Shams Maternity Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 8, 2023
• Study Start: June 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2020
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)