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Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)

Primary Purpose

Placenta Accreta

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
packing placental site with hydrogen peroxide soaked towels
normal Saline
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Placenta Accreta

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Age from 18-40 years BMI < 35 kg/m2 Pregnant patients with placenta previa . Placenta accrete FIGO grade 1 . Vitally stable . Candidate for conservative management. No major intra-operative bleeding. Exclusion Criteria: Vitally unstable . Massive pre- or intra-operative bleeding. Medical disorders ( e.g. : hypertension , cardiac …. ) Placenta accrete , FIGO grades 2 or 3 . Not indicated for conservative management.

Sites / Locations

  • Kasr Alainy outpatient infertility clinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

hydrogen peroxide group

normal Saline solution

Arm Description

hydrogen peroxide group Irrigation of the placental bed with 100 ml 3% hydrogen peroxide , followed by packing with a towel highly soaked hydrogen peroxide solution (Pozitif Kimya, İstanbul, Turkey) , freshly prepared by a 50% dilution with a normal saline solution.(

Packing the placental bed with a towel soaked with normal Saline solution

Outcomes

Primary Outcome Measures

control of intra-operative bleeding from placental bed
control of intra-operative bleeding from placental bed

Secondary Outcome Measures

Estimated intraoperative blood loss
Estimated intraoperative blood loss by towel saturarion , amount of blood in suction , and pre& postoperative hemoglobin and hematocrite
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

First Posted
August 28, 2023
Last Updated
September 1, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06030492
Brief Title
Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)
Official Title
Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 15, 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 (1) . Currently, more than 90% of women diagnosed with PAS also have a placenta praevia (2), 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 . Hydrogen peroxide is well-known for its antimicrobial and antiseptic properties. It is used to clean surgical cuts for better localization of bleeding focus in surgery and orthopedics and burn excisions to induce hemostasis . Topical application of hydrogen peroxide was proven to induce hemostasis and reduce operative time in both tonsillectomy and adenoidectomy .
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. The aim of the study is to evaluate the efficacy of hydrogen peroxide for controlling bleeding from placental bed in caesarian section for placenta previa/ Accreta spectrum (PAS). • 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 : hydrogen peroxide group (n=42) Group B : control group (normal Saline solution) (n=42) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta

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
hydrogen peroxide group
Arm Type
Experimental
Arm Description
hydrogen peroxide group Irrigation of the placental bed with 100 ml 3% hydrogen peroxide , followed by packing with a towel highly soaked hydrogen peroxide solution (Pozitif Kimya, İstanbul, Turkey) , freshly prepared by a 50% dilution with a normal saline solution.(
Arm Title
normal Saline solution
Arm Type
Placebo Comparator
Arm Description
Packing the placental bed with a towel soaked with normal Saline solution
Intervention Type
Drug
Intervention Name(s)
packing placental site with hydrogen peroxide soaked towels
Intervention Description
Skin is incised either midline or Pfannenstiel incision according to clinical situation , bladder dissection will be done , uterus will be incised by transverse lower segment incision , followed by delivery of the baby. Uterine massage , ecbolics & a trial for delivery of the placenta will be done Irrigation of the placental bed with 100 ml 3% hydrogen peroxide , followed by packing with a towel highly soaked hydrogen peroxide solution (Pozitif Kimya, İstanbul, Turkey) , freshly prepared by a 50% dilution with a normal saline solution
Intervention Type
Drug
Intervention Name(s)
normal Saline
Intervention Description
Skin is incised either midline or Pfannenstiel incision according to clinical situation , bladder dissection will be done , uterus will be incised by transverse lower segment incision , followed by delivery of the baby. Uterine massage , ecbolics & a trial for delivery of the placenta will be done. Packing the placental bed with a towel soaked with normal Saline solution
Primary Outcome Measure Information:
Title
control of intra-operative bleeding from placental bed
Description
control of intra-operative bleeding from placental bed
Time Frame
3 minutes after application of topical drug , identified as arrest of bleeding or minimal oozing from placental bed with good general condition & no hemoglobin drop
Secondary Outcome Measure Information:
Title
Estimated intraoperative blood loss
Description
Estimated intraoperative blood loss by towel saturarion , amount of blood in suction , and pre& postoperative hemoglobin and hematocrite
Time Frame
from begining to end of surgery
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
3 minutes after topical application , if bleeding continued
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
within 1st 24 hours postoperative

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 18-40 years BMI < 35 kg/m2 Pregnant patients with placenta previa . Placenta accrete FIGO grade 1 . Vitally stable . Candidate for conservative management. No major intra-operative bleeding. Exclusion Criteria: Vitally unstable . Massive pre- or intra-operative bleeding. Medical disorders ( e.g. : hypertension , cardiac …. ) Placenta accrete , FIGO grades 2 or 3 . Not indicated for conservative management.
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 infertility 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
16272036
Citation
Sheiner E, Sarid L, Levy A, Seidman DS, Hallak M. Obstetric risk factors and outcome of pregnancies complicated with early postpartum hemorrhage: a population-based study. J Matern Fetal Neonatal Med. 2005 Sep;18(3):149-54. doi: 10.1080/14767050500170088.
Results Reference
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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
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PubMed Identifier
18318724
Citation
Wasserbauer S, Perez-Meza D, Chao R. Hydrogen peroxide and wound healing: a theoretical and practical review for hair transplant surgeons. Dermatol Surg. 2008 Jun;34(6):745-50. doi: 10.1111/j.1524-4725.2008.34141.x. Epub 2008 Mar 3.
Results Reference
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Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)

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