PDIUC Protocol for Placental Accreta

Not Applicable

• Conditions: Placenta Accreta
• Interventions: Procedure: PDI-UC protocol

• Registration Number: NCT03273569
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2017-08-05
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-04
• Last Update Submitted: 2017-09-04
• Study First Posted: 2017-09-06
• Last Update Posted: 2017-09-06
• Study Start: 2017-10-01
• Primary Completion: 2018-03-30
• Study Completion: 2018-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women with placenta accreta	PDI-UC protocol	PDI-UC protocol

Primary Outcome Measures

Name	Time	Method
Uterine conservation	Intra-operative (during the time of Cesarean delivery)	Successive Uterine conservation; no peripartum hysterectomy needed

Secondary Outcome Measures

Name	Time	Method
Severe primary postpartum hemorrhage	From delivery of the fetus to 1 hour after delivery of the fetus	Amount of postpartum bleeding \> 1500 ml
Primary postpartum hemorrhage	From delivery of the fetus to 1 hour after delivery of the fetus	Amount of postpartum bleeding \> 1000 ml
Bladder injury	Intra-operative (during the time of Cesarean delivery)	Incidental injury of the bladder during delivery of the placenta or control of bleeding
Surgical site infection	Up to 2 weeks after Cesarean delivery	Cesarean wound infection
Bowel injury	Intra-operative (during the time of Cesarean delivery)	Incidental injury of the bladder during delivery of the placenta or control of bleeding
Drop in hemoglobin level	Hemoglobin 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