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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Partum Hemorrhage

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

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

First Posted
August 1, 2017
Last Updated
June 20, 2020
Sponsor
Assiut University
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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

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