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PDIUC Protocol for Placental Accreta (PDIUC)

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ClinicalTrials.gov Identifier: NCT03273569
Recruitment Status : Unknown
Verified September 2017 by Sherif Abdelkarim Mohammed Shazly, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Sherif Abdelkarim Mohammed Shazly, 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.

Condition or disease Intervention/treatment Phase
Placenta Accreta Procedure: PDI-UC protocol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Women with placenta accreta at the time of Cesarean delivery
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preplacental Delivery Intervention for Uterine Conservation Protocol: a Novel Approach for Management of Placenta Accreta
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Uterine conservation [ Time Frame: Intra-operative (during the time of Cesarean delivery) ]
    Successive Uterine conservation; no peripartum hysterectomy needed


Secondary Outcome Measures :
  1. Primary postpartum hemorrhage [ Time Frame: From delivery of the fetus to 1 hour after delivery of the fetus ]
    Amount of postpartum bleeding > 1000 ml

  2. Severe primary postpartum hemorrhage [ Time Frame: From delivery of the fetus to 1 hour after delivery of the fetus ]
    Amount of postpartum bleeding > 1500 ml

  3. Bladder injury [ Time Frame: Intra-operative (during the time of Cesarean delivery) ]
    Incidental injury of the bladder during delivery of the placenta or control of bleeding

  4. Bowel injury [ Time Frame: Intra-operative (during the time of Cesarean delivery) ]
    Incidental injury of the bladder during delivery of the placenta or control of bleeding

  5. Surgical site infection [ Time Frame: Up to 2 weeks after Cesarean delivery ]
    Cesarean wound infection

  6. Drop in hemoglobin level [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273569


Contacts
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Contact: Sherif Shazly, MBBCh, MSc +15075131392 sherify2k2@gmail.com
Contact: Ahmed Abbas, MBBCh, MD +201003385183 bmr90@hotmail.com

Sponsors and Collaborators
Assiut University

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Responsible Party: Sherif Abdelkarim Mohammed Shazly, Assistant lecturer, OBGYN department; principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03273569     History of Changes
Other Study ID Numbers: PDIUC001
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases