NCT03431116

Brief Summary

Placenta Previa is defined as a placenta implanted in the lower segment of the uterus, presenting ahead of the leading pole of the fetus (over or near the internal os). The prevalence of placenta previa has been estimated to be approximately 0.5% of all pregnancies, and this increase correlates to the elevated cesarean section rate . In Egypt, the prevalence of placenta previa is around 1.3% in Sohag Governorate and 1.5% in Aswan region according to. Although various studies have tried to address risk factors associated with Placenta Previa development, the etiology of placenta previa still remains obscure. Several risk actors have been identified as strong contributors to placenta previa development. It is also a significant contributor to severe postpartum hemorrhage.Risk factors include; history of previous cesarean section, advanced maternal age, history of previous abortions, high parity and substance abuse during pregnancy (cigarette smoking), placental size (multiple pregnancy), endometrial damage (previous dilatation and curettage), uterine scars and pathology (previous myomectomy or endometritis), placental pathology (marginal cord insertions and succenturiate lobes), previous placental Previa, and curiously.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

6 months

First QC Date

February 7, 2018

Last Update Submit

February 7, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The distance between lower edge of the placenta and internal os by ultrasound (millimeter)

    12 weeks

Study Arms (1)

Low implanted placenta group

Radiation: ultrasound

Interventions

ultrasoundRADIATION

to detect the placental site

Low implanted placenta group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

low implanted placenta women

You may qualify if:

  • Pregnant women between 18-24 weeks.
  • Diagnosed to have low implanted placenta by ultrasound

You may not qualify if:

  • Patient refused to follow-up in our setting.
  • Patient refused to perform Trans-vaginal ultrasound in the second trimester of gestation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Placenta Previa

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 13, 2018

Study Start

October 1, 2016

Primary Completion

March 30, 2017

Study Completion

April 30, 2017

Last Updated

February 13, 2018

Record last verified: 2018-02

Locations