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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 .
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) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hydrogen peroxide group | Experimental | 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.( |
|
| normal Saline solution | Placebo Comparator | Packing the placental bed with a towel soaked with normal Saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| packing placental site with hydrogen peroxide soaked towels | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| bassiony dabian, MD | Contact | 1095195513 | bassiony.dabian@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Alainy outpatient infertility clinic | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16272036 | Background | 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. | |
| 29405319 | Background | 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. |
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|
| normal Saline | Drug | 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 |
|
Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy |
| 3 minutes after topical application , if bleeding continued |
| 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 |
| 18318724 | Background | 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. |
| ID | Term |
|---|---|
| D010921 | Placenta Accreta |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010922 | Placenta Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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