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).
150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.
This study's planned enrollment of 84 is above the median of 70 across 67 interventional studies indexed under Placenta Accreta.
Browse Placenta Accreta studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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