NCT04082507

Brief Summary

The aim of the study is to compare between alpha-fetoproteine as a biological marker and between ultrasound and Doppler in prediction of morbid adherent placenta.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2019

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

2.7 years

First QC Date

August 29, 2019

Last Update Submit

September 6, 2019

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

  • Maternal serum alpha-fetoprotein

    ng/ml or MOM(Multiple of the median)

    From 28weeks to 37 weeks

Study Arms (2)

Non_adherent plcenta

placenta separated within 15 minutes after delivery of fetus

Adherent placenta

placenta dosenot separated within 15 minutes after delivery of fetus

Diagnostic Test: Serum alpha-fetoproteine

Interventions

Serum alpha-fetoproteineDIAGNOSTIC_TEST

Midtrimesteric serum alpha-fetoprotein mesurment with 2D US and 3D power Doppler with MS US scan .

Also known as: 2D Ultrasound, 3D power doppler with MS US
Adherent placenta

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

150 pregnant women from 28wk to full term who are attending outpatient clinic and emergency room ain shams university maternal hospital

You may qualify if:

  • pregnant women with history of scarred uterus
  • plcenta previa covering the scar of previous caesarean section as diagnosed by 2DU/S
  • Gestational age from 28wks to full term

You may not qualify if:

  • pregnant women with fetus with congenital anomalies
  • pregnant women with ovarian swelling
  • pregnant women with medical disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university maternity hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

August 29, 2019

First Posted

September 9, 2019

Study Start

January 1, 2017

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

September 9, 2019

Record last verified: 2019-09

Locations

EG(1)