PDIUC Protocol for Placental Accreta (PDIUC)

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

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

Study Overview

• Status: Unknown
• Conditions: Placenta Accreta
• Intervention / Treatment: Procedure: PDI-UC protocol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sherif Shazly, MBBCh, MSc; Phone Number: +15075131392; Email: sherify2k2@gmail.com
• Study Contact Backup: Name: Ahmed Abbas, MBBCh, MD; Phone Number: +201003385183; Email: bmr90@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Women with placenta accreta; PDI-UC protocol

Procedure: PDI-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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): March 30, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: August 5, 2017
• First Submitted That Met QC Criteria: September 4, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2017
• Last Update Submitted That Met QC Criteria: September 4, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: PDIUC001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No