Placenta Accreta
Conditions
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 .
Detailed 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) .
Interventions
DRUGpacking 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
DRUGnormal 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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 , …) |
Countries
Egypt
Contacts
Primary Contactbassiony dabian, MD
Outcome results
None listed