Conservative Surgical Novel Technique of Placenta Accreta in Menoufia University Hospital

NCT04161521 | Completed DMC

• 1 other identifier: Menoufia OGG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluation of maternal morbidity and mortality of our novel surgical procedure for conservative management of placenta accreta in our tertiary referral institute.

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (2)

• Outcome variables: Need for conversion to hysterectomy.

  control of bleeding and need for removal of uterus.

  30- 90 minutes

• Blood Loss.

  Amount of blood loss ,Number of packed red blood cells and blood products transfusion.

  During operation and 24 hours postpartum.

Secondary Outcomes (1)

• Intraoperative complications

  During operation and postpartum period.

Study Arms (1)

Placenta Accreta patients

OTHER

of 60 pregnant female diagnosed as placenta previa accreta recuirted from Obstetrics and Gynecology Department , Menoufia University Hospital.

Procedure: Novel Technique of Placenta Accreta in Menoufia University Hospital

Interventions

Novel Technique of Placenta Accreta in Menoufia University Hospital PROCEDURE

* Classical CS to decrease haemorrhage from placental bed. * Delievery of the fetus. * At the delivery 10 UI of oxytocin IV will be injected. * The placenta is not attempted to be delievered. * Opening of the broad ligament via round ligament division and ligation. * Gentle dissection of the urinary bladder from lateral to medial. * Bilateral uterine artery clamping at low level below the placental bed . * Gentle attempt to deliver The placenta. * If the placenta is delievered we will do bilateral uterine artery ligation at multiple levels and multiple square compression sutures(if needed) for proper hemeostasis at the placental bed. Then closure of uterine incision. * If the placenta is not delievered we will do segmental ressection of lower uterine segment including the placenta . * Intraperitoneal drain insertion.

Placenta Accreta patients

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 20 - 40 years old. 2- Gestational age between 28 - 38 weeks. 3- Any patient diagnosed as placenta previa with ultrasound criteria of accretion.
• Criteria of accretion by Colour Doppler ultrasound include: (Berkley et al., 2013).
• The presence of irregular shaped placental lacunae within the placenta.
• Thinning of myometrium overlying the placenta.
• Absence of retroplacental 'non-lucent line'.
• Protrusion of the placenta into the bladder.
• Increased vascularity of the uterine serosa-bladder interface.
• Turbulent blood flow through the lacunae on Doppler ultrasonography.

Sponsors & Collaborators

• Menoufia Obstetrics and Gynecology Group: lead

Study Sites (2)

Menoufia University hospital

Shibīn al Kawm, Menoufia, 11111, Egypt

Location

Hamed Elsayed Ellakwa

Shibīn al Kawm, 11111, Egypt

Location

Related Publications (1)

• Elkhouly NI, Solyman AE, Anter ME, Sanad ZF, El Ghazaly AN, Ellakwa HE. A new conservative surgical approach for placenta accreta spectrum in a low-resource setting. J Matern Fetal Neonatal Med. 2022 Aug;35(16):3076-3082. doi: 10.1080/14767058.2020.1808616. Epub 2020 Aug 25.

  PMID: 32842821 DERIVED

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Hamed E Ellakwa

  Menoufia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Hamed Ellakwa

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 13, 2019
• Study Start: November 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)