Placenta Accreta, Placenta Previa
Conditions
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).
Interventions
DRUGTopical adrenaline
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.
DRUGWarm 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 surgical field with towels fully saturated with warm saline solution ( 50 degrees).
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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 …. )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 , …) |
Countries
Egypt
Contacts
Primary Contactbassiony dabian, MD
Outcome results
None listed