Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)
Study Details
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 |
|---|---|---|
|
N/A |
Detailed Description
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Population of study: A total of 84 pregnant patients with placenta previa / Accreta spectrum.
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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
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
- 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]
control of intra-operative bleeding from placental bed
Secondary Outcome Measures
- Estimated intraoperative blood loss [from begining to end of surgery]
Estimated intraoperative blood loss by towel saturarion , amount of blood in suction , and pre& postoperative hemoglobin and hematocrite
- Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy [3 minutes after topical application , if bleeding continued]
Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
- immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …) [within 1st 24 hours postoperative]
immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age from 18-40 years
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BMI < 35 kg/m2
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Pregnant patients with placenta previa .
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Placenta accrete FIGO grade 1 .
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Vitally stable .
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Candidate for conservative management.
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No major intra-operative bleeding.
Exclusion Criteria:
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Vitally unstable .
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Massive pre- or intra-operative bleeding.
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Medical disorders ( e.g. : hypertension , cardiac …. )
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Placenta accrete , FIGO grades 2 or 3 .
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Not indicated for conservative management.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kasr Alainy outpatient infertility clinic | Cairo | Egypt |
Sponsors and Collaborators
- Cairo University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- MS-467-2023