NCT02765984

Brief Summary

Trans vaginal ultrasound with a partially full bladder will be done at gestational age earlier than 10 weeks to assess the site of intrauterine gestational sac to the endometrial cavity and the distance between the implantation site and the internal cervical os . Doppler assessment of the retrochorionic blood flow at the area behind the maximum chorionic tissue to detect resistance index.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

1.6 years

First QC Date

April 30, 2016

Last Update Submit

March 6, 2018

Conditions

Placenta Implantation Site

Keywords

implantation siteplacental siteDoppler

Outcome Measures

Primary Outcomes (1)

  • Distance between the implantation site and the internal cervical os

    10 weeks to 40 weeks gestational age

Study Arms (2)

normal placental site

women with normal implantation site at early trimester with normal placental site

Device: Transvaginal ultrasound

Low placental site

women with low implantation site at early trimester with low placental site

Device: Transvaginal ultrasound

Interventions

Transvaginal ultrasoundDEVICE

transvaginal ultrasound done before 10 weeks gestational age measuring the distance between the lower end of the hyperechoic trophoblast ring of the gestational sac and the inner cervical os

Low placental sitenormal placental site

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women at their early trimester with or without cesarean section scar

You may qualify if:

  • Single intrauterine pregnancy
  • Gestational age less than 10 weeks

You may not qualify if:

  • Any condition distorting uterine cavity as myoma, uterine anomalies.
  • Absent fetal pulsations
  • Any condition needing termination of early pregnancy as molar pregnancy or severe deteriorating maternal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Maged

Cairo, 12151, Egypt

RECRUITING

Study Officials

  • Ahmed Maged, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

0020201005227404dr_ahmedmaged@kasralainy.edu.eg

Asmaa Ogila, MD

CONTACT

+20201001936908drasmaaibrahim@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 30, 2016

First Posted

May 9, 2016

Study Start

May 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

EG(1)