Topical Adrenaline Versus Warm Saline Solution for Minimizing Intraperitoneal Bleeding During Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)

Last updated: September 1, 2023
Sponsor: Cairo University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Treatment

Topical adrenaline

Warm saline

Clinical Study ID

NCT06030479
MS-469-2023
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study Summary

Placenta accreta spectrum (PAS), encompassing the terms placenta accreta, increta, and percreta; abnormally invasive placenta; morbidly adherent placenta; and invasive placentation, is a leading cause of life-threatening obstetric haemorrage . Currently, more than 90% of women diagnosed with PAS also have a placenta praevia , and the combination of both conditions leads to high maternal morbidity and mortality due to massive haemorrhage at the time of birth . Maternal mortality of placenta praevia with percreta has been reported to be as high as 7% of cases .

Adrenaline has also been demonstrated to be a reasonable hemostatic agent because of its low cost, low risk, powerful vasoconstrictor, and platelet aggregation. Topical use of adrenaline is an effective and reasonable hemostatic agent in tonsillectomy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age from 18 to 40 years.
  • BMI < 35.
  • Pregnant patients with placenta previa .
  • Placenta accrete spectrum.
  • Vitally stable .

Exclusion

Exclusion Criteria:

  • Vitally unstable .
  • Massive pre- or intra-operative bleeding.
  • Medical disorders ( e.g. : hypertension , cardiac …. )

Study Design

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: Topical adrenaline
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
October 25, 2023

Study Description

  • Population of study: A total of 84 pregnant patients with placenta previa / Accreta spectrum.

  • Study location: Obstetrics and Gynecology Kasr Al-Ainy Hospital , Faculty of Medicine , Cairo University.

This is a randomized controlled trial including a total number of 84 patients representing study group , randomized in 2 equal groups , using computer generated randomization sheet on (Medcalc ®) .

Group A : Topical adrenaline group (n=42)

Group B : Warm saline Group (control) (n=42)

The aim of the study is to evaluate the efficacy of topical adrenaline for decreasing intraperitoneal bleeding during caesarian section for placenta previa/ Accreta spectrum (PAS).

Connect with a study center

  • Kasr Alainy outpatient clinic

    Cairo,
    Egypt

    Active - Recruiting

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