PDIUC Protocol for Placental Accreta

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

Detailed Description
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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.

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

Conditions
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Placenta Accreta

Intervention / Treatment
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* Procedure: PDI-UC protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Women with placenta accreta at the time of Cesarean delivery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women with placenta accreta<br>PDI-UC protocol | Procedure: PDI-UC protocol<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine conservation | Successive Uterine conservation; no peripartum hysterectomy needed | Intra-operative (during the time of Cesarean delivery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary postpartum hemorrhage | Amount of postpartum bleeding > 1000 ml | From delivery of the fetus to 1 hour after delivery of the fetus | 
| Severe primary postpartum hemorrhage | Amount of postpartum bleeding > 1500 ml | From delivery of the fetus to 1 hour after delivery of the fetus | 
| Bladder injury | Incidental injury of the bladder during delivery of the placenta or control of bleeding | Intra-operative (during the time of Cesarean delivery) | 
| Bowel injury | Incidental injury of the bladder during delivery of the placenta or control of bleeding | Intra-operative (during the time of Cesarean delivery) | 
| Surgical site infection | Cesarean wound infection | Up to 2 weeks after Cesarean delivery | 
| Drop in hemoglobin level | Change in hemoglobin before and more than 24 hours after delivery | Hemoglobin is checked 1 hour prior to Cesarean delivery and again postoperative (24 and 72 hours after Cesarean delivery) |