NCT06030492

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

August 28, 2023

Last Update Submit

September 1, 2023

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Estimated intraoperative blood loss

    from begining to end of surgery

  • 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 , …)

    within 1st 24 hours postoperative

Study Arms (2)

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.(

Drug: packing placental site with hydrogen peroxide soaked towels

normal Saline solution

PLACEBO COMPARATOR

Packing the placental bed with a towel soaked with normal Saline solution

Drug: normal Saline

Interventions

packing placental site with hydrogen peroxide soaked towelsDRUG

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

hydrogen peroxide group
normal SalineDRUG

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

normal Saline solution

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy outpatient infertility clinic

Cairo, Egypt

RECRUITING

Related Publications (3)

  • 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: 16272036BACKGROUND

  • 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: 29405319BACKGROUND

  • 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.

    PMID: 18318724BACKGROUND

MeSH Terms

Conditions

Placenta Accreta

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

bassiony dabian, MD

CONTACT

1095195513bassiony.dabian@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 11, 2023

Study Start

January 1, 2023

Primary Completion

September 30, 2023

Study Completion

October 15, 2023

Last Updated

September 11, 2023

Record last verified: 2023-09

Locations

EG(1)