Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Surgical Classification of Abnormal Placentation

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02736058
Recruitment Status : Unknown
Verified May 2016 by Ahmed Mahmoud Hussein, Cairo University.
Recruitment status was:  Recruiting
First Posted : April 13, 2016
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Mahmoud Hussein, Cairo University

Brief Summary:
Reaching the proper pre-operative diagnosis for abnormal placentation in crucial to markedly decrease the intra-operative complications as well as the maternal morbidity and mortality. In this trial researchers aim to set up some pre-operative sonographic criteria that would help in planning the surgical procedure as well as setting up a surgical classification for the abnormally adherent placenta.

Condition or disease Intervention/treatment Phase
Adherent Placenta Device: Trans- abdominal sonography Device: Trans-vaginal sonography Procedure: post-operative pathological specimen examination Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : February 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Participants
the included pregnant females will undergo trans-abdominal sonography as well as trans-vaginal sonography , to diagnose the abnormal placentation and the results will be compared to the intra- operative as well as the pathological examination of the specimen.
Device: Trans- abdominal sonography
Device: Trans-vaginal sonography
Procedure: post-operative pathological specimen examination



Primary Outcome Measures :
  1. intraoperative blood loss [ Time Frame: 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • abnormal placental site (placenta previa)

Exclusion Criteria:

  • refusal to participate in the study
  • cases with normal placental location ( fundal, anterior or posterior wall not reaching the lower uterine segment)

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): NCT02736058


Contacts
Layout table for location contacts
Contact: Ahmed M Hussein, MD 01223515652 ext 002 ahmed_mhussein@live.com
Contact: Dina M Dakhly, MD 01003498919 ext 002 dinadakhly@gmail.com

Locations
Layout table for location information
Egypt
Kasr el aini hospital Recruiting
Cairo, Egypt, 12211
Contact: Ahmed M Hussein, MD    01223515652 ext 002    ahmed_mhussein@live.com   
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Principal Investigator: Ahmed M Hussein, MD Cairo University

Layout table for additonal information
Responsible Party: Ahmed Mahmoud Hussein, Lecturer of Obstetrics and Gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT02736058     History of Changes
Other Study ID Numbers: PP2202016
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided