Surgical Technique To Control Postpartum Hemorrhage
Primary Purpose
Post Partum Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Modified surgical technique for placenta accreta
Sponsored by
About this trial
This is an interventional prevention trial for Post Partum Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- Estimated gestational age between 34 -40 weeks .
- Presence of total or focal parts of placenta accreta "morbidly adherent placenta" .
- Cases with mild vaginal bleeding or not having any vaginal bleeding
Exclusion Criteria:
- Severe attack of bleeding require an immediate intervention.
- Associated with placental abruption
- Patients with known bleeding disorders or on anticoagulant therapy.
- Preoperative decision to do peripartum hysterectomy.
Sites / Locations
- Women Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Modified surgical technique for placenta accreta
Arm Description
Outcomes
Primary Outcome Measures
Amount of blood loss (mL)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03241849
Brief Title
Surgical Technique To Control Postpartum Hemorrhage
Official Title
New Surgical Technique To Control Postpartum Hemorrhage Due To Placenta Accreta
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified surgical technique for placenta accreta
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Modified surgical technique for placenta accreta
Intervention Description
suturing of the myometrium splitted by the placenta in cases presented by placenta accreta
Primary Outcome Measure Information:
Title
Amount of blood loss (mL)
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Estimated gestational age between 34 -40 weeks .
Presence of total or focal parts of placenta accreta "morbidly adherent placenta" .
Cases with mild vaginal bleeding or not having any vaginal bleeding
Exclusion Criteria:
Severe attack of bleeding require an immediate intervention.
Associated with placental abruption
Patients with known bleeding disorders or on anticoagulant therapy.
Preoperative decision to do peripartum hysterectomy.
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Surgical Technique To Control Postpartum Hemorrhage
We'll reach out to this number within 24 hrs