Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-04 @ 3:41 AM
Study NCT ID:
NCT06030492
Status:
UNKNOWN
Last Update Posted:
2023-09-11
First Post:
2023-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010921', 'term': 'Placenta Accreta'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010922', 'term': 'Placenta Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-01', 'studyFirstSubmitDate': '2023-08-28', 'studyFirstSubmitQcDate': '2023-09-01', 'lastUpdatePostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'control of intra-operative bleeding from placental bed', 'timeFrame': '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', 'description': 'control of intra-operative bleeding from placental bed'}], 'secondaryOutcomes': [{'measure': 'Estimated intraoperative blood loss', 'timeFrame': 'from begining to end of surgery', 'description': 'Estimated intraoperative blood loss by towel saturarion , amount of blood in suction , and pre\\& postoperative hemoglobin and hematocrite'}, {'measure': 'Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy', 'timeFrame': '3 minutes after topical application , if bleeding continued', 'description': 'Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy'}, {'measure': 'immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)', 'timeFrame': 'within 1st 24 hours postoperative', 'description': 'immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Accreta']}, 'referencesModule': {'references': [{'pmid': '16272036', 'type': 'BACKGROUND', '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.'}, {'pmid': '29405319', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18318724', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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 .\n\nHydrogen 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 .', 'detailedDescription': '* Population of study: A total of 84 pregnant patients with placenta previa / Accreta spectrum.\n* Study location: Obstetrics and Gynecology Kasr Al-Ainy Hospital , Faculty of Medicine , Cairo University.\n\nThe 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).\n\n• 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 ®) .\n\nGroup A : hydrogen peroxide group (n=42)\n\nGroup B : control group (normal Saline solution) (n=42) .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18-40 years\n* BMI \\< 35 kg/m2\n* Pregnant patients with placenta previa .\n* Placenta accrete FIGO grade 1 .\n* Vitally stable .\n* Candidate for conservative management.\n* No major intra-operative bleeding.\n\nExclusion Criteria:\n\n* Vitally unstable .\n* Massive pre- or intra-operative bleeding.\n* Medical disorders ( e.g. : hypertension , cardiac …. )\n* Placenta accrete , FIGO grades 2 or 3 .\n* Not indicated for conservative management.'}, 'identificationModule': {'nctId': 'NCT06030492', 'briefTitle': 'Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)', 'orgStudyIdInfo': {'id': 'MS-467-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hydrogen peroxide group', 'description': '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.(', 'interventionNames': ['Drug: packing placental site with hydrogen peroxide soaked towels']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal Saline solution', 'description': 'Packing the placental bed with a towel soaked with normal Saline solution', 'interventionNames': ['Drug: normal Saline']}], 'interventions': [{'name': 'packing placental site with hydrogen peroxide soaked towels', 'type': 'DRUG', 'description': '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.\n\nUterine 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', 'armGroupLabels': ['hydrogen peroxide group']}, {'name': 'normal Saline', 'type': 'DRUG', 'description': '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.\n\nUterine massage , ecbolics \\& a trial for delivery of the placenta will be done.\n\nPacking the placental bed with a towel soaked with normal Saline solution', 'armGroupLabels': ['normal Saline solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'bassiony dabian, MD', 'role': 'CONTACT', 'email': 'bassiony.dabian@gmail.com', 'phone': '1095195513'}], 'facility': 'Kasr Alainy outpatient infertility clinic', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'bassiony dabian, MD', 'role': 'CONTACT', 'email': 'bassiony.dabian@gmail.com', 'phone': '1095195513'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of obstetrics and gynecology', 'investigatorFullName': 'Bassiony Dabian', 'investigatorAffiliation': 'Cairo University'}}}}