NCT01279369

Brief Summary

The purpose of this study is to determine if the presence of fetal fibronectin in the cervicovaginal secretions of pregnant patients with minor maternal trauma predicts impending preterm delivery due to abruptio placenta.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

3 years

First QC Date

January 14, 2011

Last Update Submit

May 1, 2018

Conditions

Pregnancy RelatedTraumaAbruptio Placentae

Keywords

PregnancyTraumaPlacental AbruptionFetal fibronectin

Outcome Measures

Primary Outcomes (1)

  • Delivery within 2 weeks of the trauma event

    2 weeks

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients eligible for inclusion in the study are women aged 18 or over with singleton intrauterine pregnancy ≥20 weeks gestational age and ≤35 weeks gestational age presenting to the Winthrop University Hospital Labor \& Delivery triage unit with a chief complaint of maternal trauma.

You may qualify if:

  • Singleton intrauterine pregnancy ≥20 weeks and ≤35 weeks gestational age

You may not qualify if:

  • Maternal shock
  • Unstable vital signs
  • Altered sensorium
  • Head injury resulting in coma
  • signs or symptoms of intraperitoneal bleeding
  • Emergency laparotomy for fetal or maternal indications
  • Bone fractures
  • History of previous abruptio placenta
  • Known or suspected placenta previa
  • Rupture of membranes
  • Multiple gestation
  • Advanced cervical dilatation ≥3cm
  • Non-reassuring fetal status requiring intervention
  • Vaginal bleeding on presentation
  • History of intercourse and/or digital vaginal exam and/or vaginal ultrasound ≤24 hours prior to presentation
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fetal fibronectin

MeSH Terms

Conditions

Wounds and InjuriesAbruptio Placentae

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Officials

  • Wendy L. Kinzler, M.D.

    Winthrop University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 19, 2011

Study Start

October 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

May 7, 2018

Record last verified: 2018-05

Locations

US(1)