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PDIUC Protocol for Placental Accreta

Preplacental Delivery Intervention for Uterine Conservation Protocol: a Novel Approach for Management of Placenta Accreta

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03273569
Acronym
PDIUC
Enrollment
30
Registered
2017-09-06
Start date
2017-10-01
Completion date
2018-06-01
Last updated
2017-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Accreta

Brief summary

The aim of this study is to evaluate a novel protocol to conserve the uterus during Cesarean delivery indicated for placenta accreta.

Detailed description

Placenta accreta is a morbid obstetric condition that describes variable non-physiologic invasion of the placenta into the the uterine wall. The incidence of placenta accreta, as a serious cause of postpartum hemorrhage, has substantially increased secondary to increase the rate of Cesarean delivery. Placenta accreta is primarily managed by peripartum hysterectomy prior to delivery of the placenta to avoid uncontrolled bleeding. However, in addition to the surgical risks, hysterectomy is psychologically morbid to many women particularly younger women and women with low parity. Therefore, several conservative options were studied to provide an alternative for hysterectomy in these women. Our study is designated to evaluate a proposed protocol of multi-step interventions to reduce the anticipated amount of bleeding prior to delivery of the placenta.

Interventions

PROCEDUREPDI-UC protocol

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Women with placenta accreta at the time of Cesarean delivery

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Emergency Cesarean delivery (women with active bleeding) * Women with cardiac diseases * Women with coagulopathy

Design outcomes

Primary

MeasureTime frameDescription
Uterine conservationIntra-operative (during the time of Cesarean delivery)Successive Uterine conservation; no peripartum hysterectomy needed

Secondary

MeasureTime frameDescription
Severe primary postpartum hemorrhageFrom delivery of the fetus to 1 hour after delivery of the fetusAmount of postpartum bleeding \> 1500 ml
Bladder injuryIntra-operative (during the time of Cesarean delivery)Incidental injury of the bladder during delivery of the placenta or control of bleeding
Primary postpartum hemorrhageFrom delivery of the fetus to 1 hour after delivery of the fetusAmount of postpartum bleeding \> 1000 ml
Surgical site infectionUp to 2 weeks after Cesarean deliveryCesarean wound infection
Drop in hemoglobin levelHemoglobin is checked 1 hour prior to Cesarean delivery and again postoperative (24 and 72 hours after Cesarean delivery)Change in hemoglobin before and more than 24 hours after delivery
Bowel injuryIntra-operative (during the time of Cesarean delivery)Incidental injury of the bladder during delivery of the placenta or control of bleeding

Contacts

Primary ContactSherif Shazly, MBBCh, MSc
sherify2k2@gmail.com+15075131392
Backup ContactAhmed Abbas, MBBCh, MD
bmr90@hotmail.com+201003385183

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026