Surgical Technique To Control Postpartum Hemorrhage

New Surgical Technique To Control Postpartum Hemorrhage Due To Placenta Accreta

Placenta accreta is an obstetrical complication where the placenta becomes firmly adherent to the uterine wall. Placenta accreta can lead to considerable maternal morbidity and mortality due to hemorrhage, infection, or other surgical complications such as those resulting from hysterectomy. Retained placenta accreta is usually a rare condition, but its prevalence is increasing due to the rise in the rate of deliveries by Cesarean section.

Placenta accreta is a potentially life-threatening obstetric condition that requires a multidisciplinary approach to management. The incidence of placenta accreta has increased and seems to parallel the increasing cesarean delivery rate. Women at greatest risk of placenta accreta are those who have myometrial damage caused by a previous cesarean delivery with either an anterior or posterior placenta previa overlying the uterine scar. Diagnosis of placenta accreta before delivery allows multidisciplinary planning in an attempt to minimize potential maternal or neonatal morbidity and mortality.

Study Overview

• Status: Completed
• Conditions: Post Partum Hemorrhage
• Intervention / Treatment: Procedure: Modified surgical technique for placenta accreta

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Women Health Hospital - Assiut university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Estimated gestational age between 34 -40 weeks .
2. Presence of total or focal parts of placenta accreta "morbidly adherent placenta" .
3. Cases with mild vaginal bleeding or not having any vaginal bleeding

Exclusion Criteria:

1. Severe attack of bleeding require an immediate intervention.
2. Associated with placental abruption
3. Patients with known bleeding disorders or on anticoagulant therapy.
4. Preoperative decision to do peripartum hysterectomy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Modified surgical technique for placenta accreta	Procedure: Modified surgical technique for placenta accreta; suturing of the myometrium splitted by the placenta in cases presented by placenta accreta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of blood loss (mL)	24 hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 5, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 20, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: STPPGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No