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

Cairo University (CU)

Status: Enrolling

Conditions: Placenta Accreta

Treatments: Drug: packing placental site with hydrogen peroxide soaked towels; Drug: normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06030492

MS-467-2023

Details and patient eligibility

About

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 .

Full 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) .

Enrollment: 84 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups, including a placebo group

hydrogen peroxide group

Experimental group

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.(

Treatment:

Drug: packing placental site with hydrogen peroxide soaked towels

normal Saline solution

Placebo Comparator group

Description:

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

Treatment:

Drug: normal Saline