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Role of Ultrasound in Diagnosis of Placenta Previa and MAP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416296
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
Cairo University
National Research Center, Egypt
Information provided by (Responsible Party):
Mahmoud Alalfy, Aljazeera Hospital

Brief Summary:
Placenta accreta occurs when the placental implantation is abnormal. The marked rise in incidence has been assumed the increasing prevalence of cesarean delivery in recent years.

Condition or disease
Morbidly Adherent Placenta

Detailed Description:
The most accepted theory is that abnormal placentation . The most important risk factor for placenta accreta is placenta previa after a prior cesarean delivery. The first clinical manifestation of placenta accreta is usually severe , life-threatening hemorrhage. The recommended intervention of suspected placenta accreta is planned preterm cesarean hysterectomy with the placenta left in situ.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Role of Ultrasound TA,TV,TP in Diagnosis of Placenta Previa and MAP(Morbidly Adherent Placenta )
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
normal placenta
TA , TV ,TP us
placenta previa and MAP
TA,TV.TP us



Primary Outcome Measures :
  1. number of participants who will be diagnosed to have normal placenta or placenta previa or morbidly adherent placenta by US [ Time Frame: within 6 weeks ]

Biospecimen Retention:   Samples Without DNA
uterus in case of hysterectomy after cesarean hysterectomy


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant females with GA above 34 weeks
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
pregnant females with previous cs will be subjected to US to assess placental location and MAP
Criteria

Inclusion Criteria:

  • pregnant ladies with previous cesarean sections
  • GA above 34 weeks

Exclusion Criteria:

  • Primigravida patients
  • GA below 34 weeks

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): NCT03416296


Contacts
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Contact: Mahmoud Alalfy 01002611058 mahmoudalalfy@ymail.com
Contact: Ahmed Elgazzar 01014005959

Locations
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Egypt
Algazeerah Recruiting
Giza, Egypt
Contact: Mahmoud Alalfy, master    +201002611058    mahmoudalalfy@ymail.com   
Contact: Ahmed Elgazzar, M.D    +201014005959      
Principal Investigator: Mahmoud Alalfy, master         
Sponsors and Collaborators
Aljazeera Hospital
Cairo University
National Research Center, Egypt
Investigators
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Principal Investigator: Mahmoud Alalfy Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
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Responsible Party: Mahmoud Alalfy, Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital, Aljazeera Hospital
ClinicalTrials.gov Identifier: NCT03416296    
Other Study ID Numbers: placenta
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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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 Previa
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases