NCT02031393

Brief Summary

The purpose of this study is to determine whether we can establish different markers suc as mean arterial pressure , flow in the uterine arteries, biochemical markers in maternal blood and more un the first trimester, in order to screen for twin pregnancies that are more likely to develop adverse pregnancy outcome: early delivery, pre eclampsia or small fetuses.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 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

September 1, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 31, 2014

Status Verified

December 1, 2013

Enrollment Period

4.3 years

First QC Date

January 8, 2014

Last Update Submit

January 30, 2014

Conditions

Small for Gestational Age (Disorder)Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

  • The development of preeclampsia

    the women will be approached after birth to asses whether they developed preeclampsia or pregnancy induced hypertension

    after delivery

Secondary Outcomes (1)

  • intra uterine growth restriction

    after delivery

Study Arms (2)

singelton pregnancy

will be followed 11-14 weeks and 19-28 weeks of gestation and after birth

twin pregnancy

will be followed 11-14 weeks and 19-28 weeks of gestation and after birth

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women that will come to our first trimester clinic inorder to preform first trimester screeninig

You may qualify if:

  • pregnant women from 11 -14 weeks of gestation

You may not qualify if:

  • nuchal thickness above 3 mm,
  • Chronic hypertension,
  • thrombophilia,
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofe obstetric department

Be’er Ya‘aqov, Zrifin, 70300, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal serum

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 9, 2014

Study Start

September 1, 2009

Primary Completion

January 1, 2014

Study Completion

July 1, 2014

Last Updated

January 31, 2014

Record last verified: 2013-12

Locations

IL(1)