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

• ClinicalTrials.gov Identifier: NCT06030492
• Recruitment Status: Recruiting
• First Posted: September 11, 2023
• Last Update Posted: September 11, 2023
• Sponsor: Cairo University
• Information provided by (Responsible Party): Bassiony Dabian, Cairo University

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 .

Condition or disease	Intervention/treatment	Phase
Placenta Accreta	Drug: packing placental site with hydrogen peroxide soaked towels; Drug: normal Saline	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)
• Actual Study Start Date: January 1, 2023
• Estimated Primary Completion Date: September 30, 2023
• Estimated Study Completion Date: October 15, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: hydrogen peroxide group; 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; 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
Placebo Comparator: normal Saline solution; Packing the placental bed with a towel soaked with normal Saline solution	Drug: normal Saline; 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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   control of intra-operative bleeding from placental bed

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: bassiony dabian, MD; 1095195513; bassiony.dabian@gmail.com

Locations

Egypt

Kasr Alainy outpatient infertility clinic; Recruiting

Cairo, Egypt

Contact: bassiony dabian, MD 1095195513 bassiony.dabian@gmail.com

Sponsors and Collaborators

Cairo University

More Information

Publications:

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.

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.

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.

• Responsible Party: Bassiony Dabian, lecturer of obstetrics and gynecology, Cairo University
• ClinicalTrials.gov Identifier: NCT06030492
• Other Study ID Numbers: MS-467-2023
• First Posted: September 11, 2023
• Last Update Posted: September 11, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Placenta Accreta; Placenta Previa; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Hydrogen Peroxide; Anti-Infective Agents, Local; Anti-Infective Agents