PDIUC Protocol for Placental Accreta
PDIUC
Preplacental Delivery Intervention for Uterine Conservation Protocol: a Novel Approach for Management of Placenta Accreta
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
The aim of this study is to evaluate a novel protocol to conserve the uterus during Cesarean delivery indicated for placenta accreta.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2017
CompletedFirst Posted
Study publicly available on registry
September 6, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedSeptember 6, 2017
September 1, 2017
6 months
August 5, 2017
September 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Uterine conservation
Successive Uterine conservation; no peripartum hysterectomy needed
Intra-operative (during the time of Cesarean delivery)
Secondary Outcomes (6)
Primary postpartum hemorrhage
From delivery of the fetus to 1 hour after delivery of the fetus
Severe primary postpartum hemorrhage
From delivery of the fetus to 1 hour after delivery of the fetus
Bladder injury
Intra-operative (during the time of Cesarean delivery)
Bowel injury
Intra-operative (during the time of Cesarean delivery)
Surgical site infection
Up to 2 weeks after Cesarean delivery
- +1 more secondary outcomes
Study Arms (1)
Women with placenta accreta
EXPERIMENTALPDI-UC protocol
Interventions
Preplacental delivery intervention for uterine conservation protocol starts after delivery of the fetus during Cesarean delivery and consists of delayed cord clamping, intramyometrial injection of vasopressin, subdecidual injection of saline, ligation of the uterine arteries, multiple 8 compression sutures, followed by delivery of the placenta, application of pressure and interrupted sutures if needed
Eligibility Criteria
You may qualify if:
- Women with diagnosis of placenta accreta (US or MRI based diagnosis)
- Women who decline hysterectomy
- Pregnancy at 28 weeks of gestation or beyond
- Women who accept to participate in the study
You may not qualify if:
- Emergency Cesarean delivery (women with active bleeding)
- Women with cardiac diseases
- Women with coagulopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer, OBGYN department; principal investigator
Study Record Dates
First Submitted
August 5, 2017
First Posted
September 6, 2017
Study Start
October 1, 2017
Primary Completion
March 30, 2018
Study Completion
June 1, 2018
Last Updated
September 6, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share