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

Last updated: September 1, 2023
Sponsor: Cairo University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Treatment

packing placental site with hydrogen peroxide soaked towels

normal Saline

Clinical Study ID

NCT06030492
MS-467-2023
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study 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 .

Eligibility Criteria

Inclusion

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

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

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: packing placental site with hydrogen peroxide soaked towels
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
October 15, 2023

Study 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) .

Connect with a study center

  • Kasr Alainy outpatient infertility clinic

    Cairo,
    Egypt

    Active - Recruiting

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