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

Study Overview
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Brief Summary
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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 (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
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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) .

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

Conditions
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Placenta Accreta

Intervention / Treatment
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* Drug: packing placental site with hydrogen peroxide soaked towels
* Drug: normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hydrogen peroxide group<br>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.( | Drug: packing placental site with hydrogen peroxide soaked towels<br>* 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<br>|
| Placebo Comparator: normal Saline solution<br>Packing the placental bed with a towel soaked with normal Saline solution | Drug: normal Saline<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| control of intra-operative bleeding from placental bed | 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 | 

Secondary Outcome Measures

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