NCT00613210

Brief Summary

to evaluate if sonographic measure of short uterin cervix, sludge in amniotic fluid and abnormal doppler of the uterin artery can predict preterm labor

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

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

Study Start

First participant enrolled

January 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 12, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Last Updated

February 12, 2008

Status Verified

January 1, 2008

Enrollment Period

5 months

First QC Date

January 22, 2008

Last Update Submit

February 11, 2008

Conditions

Keywords

preterm deliveryshory cervixamniotic fluid sludgeuterine artery dopplersingeltonenormal amniotic fluid indexwithout rupter of membranes24-34 weeks of gestation

Study Arms (3)

1

women without contraction at 24-34 weeks of gestation

2

women without contractions between 24-34 weeks of gestation with a history of preterm labor

3

women with preterm contractions 24-34 weeks of gestation

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women that visit a tetriary hospital for follow up

You may qualify if:

  • pregnancy between 24-34 wees of gestation

You may not qualify if:

  • lack prenatal care
  • fetal malformations stractural or genetical
  • plcenta previa
  • cerclage
  • women who underwent conization of cervix
  • polyhydramnious
  • premature rupture of membranes
  • induction of labor d/t medical condition preterm
  • women with hypertension, diabetis or preeclampsia
  • susp IUGR
  • women with a chronic illness that may interupt pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: NONE RETAINED

sonographic measurments

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Limor Man

    soroka medical center sonar unit of obstetrics and gynecology department

    PRINCIPAL INVESTIGATOR
  • limor man, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 12, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2008

Last Updated

February 12, 2008

Record last verified: 2008-01