Topical Adrenaline Versus Warm Saline Solution for Minimizing Intraperitoneal Bleeding During Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)
Primary Purpose
Placenta Accreta, Placenta Previa
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Topical adrenaline
Warm saline
Sponsored by
About this trial
This is an interventional treatment trial for Placenta Accreta
Eligibility Criteria
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 …. )
Sites / Locations
- Kasr Alainy outpatient clinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Topical Adrenaline Group
Warm saline Group
Arm Description
Topical adrenaline group
Warm saline Group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)
immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06030479
Brief Title
Topical Adrenaline Versus Warm Saline Solution for Minimizing Intraperitoneal Bleeding During Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)
Official Title
Topical Adrenaline Versus Warm Saline Solution for Minimizing Intraperitoneal Bleeding During Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS): A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
October 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta, Placenta Previa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Topical Adrenaline Group
Arm Type
Experimental
Arm Description
Topical adrenaline group
Arm Title
Warm saline Group
Arm Type
Placebo Comparator
Arm Description
Warm saline Group
Intervention Type
Drug
Intervention Name(s)
Topical adrenaline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Warm saline
Intervention Description
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).
Primary Outcome Measure Information:
Title
control of intra-operative bleeding from surgical field.
Description
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
Secondary Outcome Measure Information:
Title
Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
Description
Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
Time Frame
if bleeding continued 30 minutes after topical drugs
Title
immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)
Description
immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)
Time Frame
24 hours after delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 …. )
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
bassiony dabian, MD
Phone
1095195513
Email
bassiony.dabian@gmail.com
Facility Information:
Facility Name
Kasr Alainy outpatient clinic
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
bassiony dabian, MD
Phone
1095195513
Email
bassiony.dabian@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21381881
Citation
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.
Results Reference
background
PubMed Identifier
29405319
Citation
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.
Results Reference
background
PubMed Identifier
10772440
Citation
Hatton RC. Bismuth subgallate-epinephrine paste in adenotonsillectomies. Ann Pharmacother. 2000 Apr;34(4):522-5. doi: 10.1345/aph.19216.
Results Reference
background
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Topical Adrenaline Versus Warm Saline Solution for Minimizing Intraperitoneal Bleeding During Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)
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