PDIUC Protocol for Placental Accreta

NCT ID: NCT03273569

Last Updated: 2017-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-06-01

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.

Conditions

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Placenta Accreta

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Women with placenta accreta at the time of Cesarean delivery
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Women with placenta accreta

PDI-UC protocol

Group Type EXPERIMENTAL

PDI-UC protocol

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sherif Abdelkarim Mohammed Shazly

Assistant lecturer, OBGYN department; principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Sherif Shazly, MBBCh, MSc

Role: CONTACT

+15075131392

Ahmed Abbas, MBBCh, MD

Role: CONTACT

+201003385183

Other Identifiers

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PDIUC001

Identifier Type: -

Identifier Source: org_study_id

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