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

Placenta Accreta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030492
• Other study ID #: MS-467-2023
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: October 15, 2023

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: bassiony dabian, MD
• Phone: 1095195513
• Email: bassiony.dabian[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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) .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: October 15, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Previa

Intervention

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, Istanbul, Turkey) , freshly prepared by a 50% dilution with a normal saline solution
• 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

Locations

Country	Name	City	State
Egypt	Kasr Alainy outpatient infertility clinic	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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