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Early Prediction of Placenta Accreta by Ultrasound and Color Doppler

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: NCT03032770
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Brief Summary:
Placenta accreta is a substantially life threatening condition and one of the causes of maternal morbidity and mortality in the world. According to study done in United Kingdom, The estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities overall and 577 per 10,000 in women with both a previous cesarean delivery and placenta previa. in a tertiary south Italian center, The incidence increased from 0.12% during the 1970s, to 0.31% during the 2000s.While in United States of America, the prevalence of placenta accreta was 3.7 per 1000 deliveries.

Condition or disease Intervention/treatment
Placenta Accreta Device: two-dimensional ultrasound and color Doppler

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Study Type : Observational
Actual Enrollment : 148 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Prediction of Placenta Accreta by 2 Dimensional Transvaginal Ultrasound and Color Doppler
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
placenta accreta
Having at least one sign suggestive of placenta accreta
Device: two-dimensional ultrasound and color Doppler
the eligible participants will be searched for signs suggestive of placenta accreta; low implantation of the gestational sac (<4cm from the external os), presence of placental lakes, Disruption of placental-myometrial interface and trophoblast overlapping a uterine scar by 2 dimensional transvaginal ultrasound and Intraplacental dilated vessels, turbulent blood flows and greatly increased periplacental vascularity by Doppler ultrasound by level II sonographer and co-investigator under his supervision using ultrasound device.

normal placenta
Never having any of the signs suggestive of placenta accreta
Device: two-dimensional ultrasound and color Doppler
the eligible participants will be searched for signs suggestive of placenta accreta; low implantation of the gestational sac (<4cm from the external os), presence of placental lakes, Disruption of placental-myometrial interface and trophoblast overlapping a uterine scar by 2 dimensional transvaginal ultrasound and Intraplacental dilated vessels, turbulent blood flows and greatly increased periplacental vascularity by Doppler ultrasound by level II sonographer and co-investigator under his supervision using ultrasound device.




Primary Outcome Measures :
  1. Confirmation of occurrence of placenta accreta during delivery. [ Time Frame: duration of pregnancy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
first trimester pregnancy between 11 weeks and 13 weeks.
Criteria

Inclusion Criteria:

  1. Low implantation of the gestational sac (<4 cm from external os) by transvaginal ultrasound
  2. Presence of placental lakes by transvaginal ultrasound
  3. Disruption of placental-myometrial interface by transvaginal ultrasound
  4. Trophoblast overlapping a uterine scar (Cesarean section, myomectomy) by transvaginal ultrasound
  5. Intraplacental dilated vessels by Doppler ultrasound
  6. Turbulent blood flows by Doppler ultrasound
  7. Greatly increased periplacental vascularity by Doppler ultrasound

Exclusion Criteria:

a) Cases far away from our hospital and expected to be lost to be followed. b) Pregnant women who will refuse to Participate

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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): NCT03032770


Locations
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Egypt
Assiut University
Assiut, Egypt
Sponsors and Collaborators
Assiut University
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Responsible Party: Ahmed Mohamed Abbas, clinical professor, Assiut University
ClinicalTrials.gov Identifier: NCT03032770    
Other Study ID Numbers: USPA
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases