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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Adrenaline Group | Experimental | Topical adrenaline group |
|
| Warm saline Group | Placebo Comparator | Warm saline Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical adrenaline | Drug | 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. |
| 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 |
| 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 , …) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| bassiony dabian, MD | Contact | 1095195513 | bassiony.dabian@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Alainy outpatient clinic | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21381881 | Background | Solheim KN, Esakoff TF, Little SE, Cheng YW, Sparks TN, Caughey AB. The effect of cesarean delivery rates on the future incidence of placenta previa, placenta accreta, and maternal mortality. J Matern Fetal Neonatal Med. 2011 Nov;24(11):1341-6. doi: 10.3109/14767058.2011.553695. Epub 2011 Mar 7. | |
| 29405319 | Background |
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|
| Warm saline | Drug | 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). |
|
immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …) |
| 24 hours after delivery |
| Jauniaux E, Bhide A, Kennedy A, Woodward P, Hubinont C, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Prenatal diagnosis and screening. Int J Gynaecol Obstet. 2018 Mar;140(3):274-280. doi: 10.1002/ijgo.12408. No abstract available. |
| 10772440 | Background | Hatton RC. Bismuth subgallate-epinephrine paste in adenotonsillectomies. Ann Pharmacother. 2000 Apr;34(4):522-5. doi: 10.1345/aph.19216. |
| ID | Term |
|---|---|
| D010921 | Placenta Accreta |
| D010923 | Placenta Previa |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010922 | Placenta Diseases |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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