An interventional study of Topical adrenaline and Warm saline in Placenta Accreta and Placenta Previa, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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).
Exclusion Criteria:
Topical adrenaline group
Drug: Topical adrenaline
Warm saline Group
Drug: Warm saline
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.
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).
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.
Time frame: 30 minutes after application of topical drug
Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
Time frame: 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 , ...)
Time frame: 24 hours after delivery
Plan to share: Undecided
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Cairo University