the Treatment of Postpartum Hemorrhage Due to Placenta Previa Complete Centralis (PPH)
Primary Purpose
Placenta Previa Complete Centralis
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
lower uterine compression sutures
Sponsored by
About this trial
This is an interventional treatment trial for Placenta Previa Complete Centralis focused on measuring Postpartum Hemorrhage, Placenta Previa, uterine cavity
Eligibility Criteria
Inclusion Criteria:
- a gestation age of ≥ 28 weeks and antepartum hemorrhage;
- intraoperative postpartum hemorrhage and discovery of a placenta previa;
- successful removal of the placenta
Exclusion Criteria:
- shock due to massive blood loss
- failure of successful removal of the placenta
Sites / Locations
- Benha univesity hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
all patients
Arm Description
intervention is lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis.
Outcomes
Primary Outcome Measures
Treatment of Postpartum Hemorrhage
Secondary Outcome Measures
evaluation of uterine cavity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02157441
Brief Title
the Treatment of Postpartum Hemorrhage Due to Placenta Previa Complete Centralis
Acronym
PPH
Official Title
Lower Uterine Compression Sutures for the Treatment of Postpartum Hemorrhage Due to Placenta Previa Complete Centralis; Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective: To assess the efficacy of lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis. Method: This prospective study of 50 women with postpartum hemorrhage following removal of placenta previa complete centralis during elective cesarean section. All 50 patients will have lower uterine compression sutures (involving bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch). All patients will be followed postpartum for evaluation of uterine cavity and menstrual cycles
Detailed Description
The investigators conduct a prospective study at Department of Obstetrics and Gynecology, Benha University Hospital, since June 2012 till July 2014, after approval of the study protocol by the Local Ethical Committee.
All patients provide written informed consent to undergo any procedure necessary, including lower uterine compression suturing procedure, as an attempt to avoid hysterectomy. They also provide written informed consent to undergo hysterectomy if all measures attempted to preserve the uterus fail.
All patients have placenta previa (50). The inclusion criteria are a gestation age of ≥ 28 weeks and antepartum hemorrhage; intraoperative postpartum hemorrhage and discovery of a placenta accreta; and an adherent placental part after piecemeal removal of the placenta, with bleeding from the placental site, posterior placenta previa and/or successful piecemeal removal of the placenta.
The first author performed all cesarean deliveries and assisted by the second author. We open the parietal peritoneum by sharp dissection and blunt expansion, high above the bladder, a bladder flap is made and the bladder is retracted. A small median transverse hysterotomy incision is done in the lower uterine segment. It is expanded on both sides using scissors, stopping shortly before the uterine arteries. Active delivery of the placenta is attempted by searching manually for a plane of cleavage between the placenta and the uterus after delivery of the fetus. The study technique comprise lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa Complete Centralis
Keywords
Postpartum Hemorrhage, Placenta Previa, uterine cavity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
all patients
Arm Type
Experimental
Arm Description
intervention is lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis.
Intervention Type
Procedure
Intervention Name(s)
lower uterine compression sutures
Intervention Description
intervention is lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis.
Primary Outcome Measure Information:
Title
Treatment of Postpartum Hemorrhage
Time Frame
during cesarean section( participants will be followed for the duration of hospital stay)
Secondary Outcome Measure Information:
Title
evaluation of uterine cavity
Time Frame
6 months after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a gestation age of ≥ 28 weeks and antepartum hemorrhage;
intraoperative postpartum hemorrhage and discovery of a placenta previa;
successful removal of the placenta
Exclusion Criteria:
shock due to massive blood loss
failure of successful removal of the placenta
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
khalid mohamed, MD
Organizational Affiliation
Department of Obstetrics and Gynecology, Benha University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Benha univesity hospital
City
Benha
State/Province
El Qualyobia
ZIP/Postal Code
13518
Country
Egypt
12. IPD Sharing Statement
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the Treatment of Postpartum Hemorrhage Due to Placenta Previa Complete Centralis
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