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

Cairo University (CU)

Status: Enrolling

Conditions: Placenta Accreta; Placenta Previa

Treatments: Drug: Warm saline; Drug: Topical adrenaline

Study type: Interventional

Funder types: Other

Identifiers

NCT06030479

MS-469-2023

Details and patient eligibility

About

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.

Full 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).

Enrollment: 84 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups, including a placebo group

Topical Adrenaline Group

Experimental group

Description:

Topical adrenaline group

Treatment:

Drug: Topical adrenaline

Warm saline Group

Placebo Comparator group

Description:

Warm saline Group

Treatment:

Drug: Warm saline