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

Not Applicable

Recruiting

• Conditions: Placenta Accreta; Placenta Previa
• Interventions: Drug: Warm saline; Drug: Topical adrenaline

• Registration Number: NCT06030479
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-08-28
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-01
• Last Update Submitted: 2023-09-01
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Primary Completion: 2023-10-15
• Study Completion: 2023-10-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warm saline Group	Warm saline	Warm saline Group
Topical Adrenaline Group	Topical adrenaline	Topical adrenaline group

Primary Outcome Measures

Name	Time	Method
control of intra-operative bleeding from surgical field.	30 minutes after application of topical drug	control of intra-operative bleeding from surgical field if bleeding stopped , or minimal oozing , towel are not soaked with blood and improvement of general condition with no hemoglobin drop.

Secondary Outcome Measures

Name	Time	Method
Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy	if bleeding continued 30 minutes after topical drugs	Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)	24 hours after delivery	immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , ...)

Trial Locations

Locations (1)

Kasr Alainy outpatient clinic; 🇪🇬 Cairo, Egypt