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

Not Applicable

Recruiting

• Conditions: Placenta Accreta
• Interventions: Drug: normal Saline; Drug: packing placental site with hydrogen peroxide soaked towels

• Registration Number: NCT06030492
• Lead Sponsor: Cairo University

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) .

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-08-28
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-01
• Last Update Submitted: 2023-09-01
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal Saline solution	normal Saline	Packing the placental bed with a towel soaked with normal Saline solution
hydrogen peroxide group	packing placental site with hydrogen peroxide soaked towels	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.(

Primary Outcome Measures

Name	Time	Method
control of intra-operative bleeding from placental bed	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	control of intra-operative bleeding from placental bed

Secondary Outcome Measures

Name	Time	Method
Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy	3 minutes after topical application , if bleeding continued	Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)	within 1st 24 hours postoperative	immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , ...)
Estimated intraoperative blood loss	from begining to end of surgery	Estimated intraoperative blood loss by towel saturarion , amount of blood in suction , and pre\& postoperative hemoglobin and hematocrite

Trial Locations

Locations (1)

Kasr Alainy outpatient infertility clinic; 🇪🇬 Cairo, Egypt