Efficacy Study of Random Placenta Margin Incision to Treat Complete Placenta Previa
Primary Purpose
Complete Placenta Previa
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Random Placenta Margin Incision
Sponsored by
About this trial
This is an interventional prevention trial for Complete Placenta Previa focused on measuring Complete Placenta Previa, Random Placenta Margin Incision, Cesarean Section, Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- A gestation age of ≥ 28 weeks
- Delivered by cesarean section
- Antepartum diagnosis of complete placenta accreta by obstetric ultrasound and doppler
Exclusion Criteria:
- Women who refuse to participate
- Pregnant women with serious diseases
Sites / Locations
- Maternal and Child Health Hospital of Foshan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All Participants
Arm Description
A random hysterotomy incision is done in the placenta margin. To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision.
Outcomes
Primary Outcome Measures
Postpartum Hemorrhage
Secondary Outcome Measures
Number of blood products transfused
Length of hospitalization
Full Information
NCT ID
NCT02695069
First Posted
February 22, 2016
Last Updated
November 9, 2017
Sponsor
Maternal and Child Health Hospital of Foshan
1. Study Identification
Unique Protocol Identification Number
NCT02695069
Brief Title
Efficacy Study of Random Placenta Margin Incision to Treat Complete Placenta Previa
Official Title
Random Placenta Margin Incision for Hemorrhage Control During Cesarean Section of Complete Placenta Previa Pregnancies
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maternal and Child Health Hospital of Foshan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy of random placenta margin incision for hemorrhage control during cesarean section of complete placenta previa pregnancies.
Detailed Description
Placenta previa is used to describe a placenta that is implanted over or very near the internal cervical os and the complete placenta previa is defined that the internal os is covered completely by placenta. This obstetric complication is associated with high risks for maternal hemorrhage and emergency peripartum hysterectomy can be the only effective action to take, although it carries many morbidities for the women especially those with low parity. Although, nowadays the obstetrician can diagnose placenta previa before delivery, it is still one of the important causes of maternal mortality. The only safe and appropriate mode of delivery for placenta previa is by cesarean delivery. In the absence of accreta, this can usually be accomplished using a lower segment uterine incision. Because of cutting through the placenta, it is often associated with increased maternal bleeding. In addition, the umbilical cord will be also excessive blood loss when the placenta is transected. Theoretically, random placenta margin incision can effectively avoid the damage of the placenta and reduce the maternal blood loss.
The investigators conduct a prospective study to assess the efficacy of random placenta margin incision for hemorrhage control during cesarean section of complete placenta previa pregnancies at Department of Obstetrics, Southern Medical University Affiliated Maternal and Child Health Hospital of Foshan, since January 2016 till December 2016, after approval of the study protocol by the Local Ethical Committee.
All participants have complete placenta previa and provide written informed consent to undergo any procedure necessary as an attempt to avoid hysterectomy. And they also provide written informed consent to undergo hysterectomy if all measures attempted to preserve the uterus fail.
To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision. The investigator performed all cesarean deliveries and assisted by the second investigator. The parietal peritoneum is opened by sharp dissection and blunt expansion, if necessary, high above the bladder, a bladder flap is made and the bladder is retracted. A random hysterotomy incision is done in the placenta margin. 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. In addition to uterotonics, measures such as "oversewing" of the placental bed, intrauterine balloon tamponade, and B-Lynch or other compression sutures are also used depending on different circumstances.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complete Placenta Previa
Keywords
Complete Placenta Previa, Random Placenta Margin Incision, Cesarean Section, Hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All Participants
Arm Type
Experimental
Arm Description
A random hysterotomy incision is done in the placenta margin. To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision.
Intervention Type
Procedure
Intervention Name(s)
Random Placenta Margin Incision
Intervention Description
A random hysterotomy incision is done in the placenta margin. To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision.
Primary Outcome Measure Information:
Title
Postpartum Hemorrhage
Time Frame
within the first 30 days after cesarean section
Secondary Outcome Measure Information:
Title
Number of blood products transfused
Time Frame
within the first 30 days after cesarean section
Title
Length of hospitalization
Time Frame
6 months after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A gestation age of ≥ 28 weeks
Delivered by cesarean section
Antepartum diagnosis of complete placenta accreta by obstetric ultrasound and doppler
Exclusion Criteria:
Women who refuse to participate
Pregnant women with serious diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhengping Liu, MD
Organizational Affiliation
Maternal and Child Health Hospital of Foshan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternal and Child Health Hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy Study of Random Placenta Margin Incision to Treat Complete Placenta Previa
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