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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Topical Adrenaline Versus Warm Saline Solution for Minimizing Intraperitoneal Bleeding During Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS): A Randomized Controlled Study

Conditions
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Placenta Accreta, Placenta Previa

Intervention / Treatment
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* Drug: Topical adrenaline
* Drug: Warm saline


Participation Criteria
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Eligibility Criteria
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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 …. )

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical Adrenaline Group<br>Topical adrenaline group | Drug: Topical adrenaline<br>* Skin is incised midline sub-umbilical incision , bladder dissection will be done , uterus will be incised by vertical upper segment incision , followed by delivery of the baby. Surgical assessment and decision for either conservative management or CS hysterectomy will be done. After completion of surgical procedure , surgical field is observed for major bleeding and patients are subjected to intervention Packing the pelvic surgical field with towels fully saturated with adrenaline 1:10000 solution.<br>|
| Placebo Comparator: Warm saline Group<br>Warm saline Group | Drug: Warm saline<br>* Skin is incised midline sub-umbilical incision , bladder dissection will be done , uterus will be incised by vertical upper segment incision , followed by delivery of the baby. Surgical assessment and decision for either conservative management or CS hysterectomy will be done. After completion of surgical procedure , surgical field is observed for major bleeding and patients are subjected to intervention Packing the surgical field with towels fully saturated with warm saline solution ( 50 degrees).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| control of intra-operative bleeding from surgical field. | 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. | 30 minutes after application of topical drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy | Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy | if bleeding continued 30 minutes after topical drugs | 
| immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …) | immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …) | 24 hours after delivery |