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The Use of Fetal Fibronectin to Predict Delivery Due to Abruptio Placenta

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01279369
Recruitment Status : Terminated (Study no longer feasible as quantitative assessment of fFN can only be performed at one laboratory.)
First Posted : January 19, 2011
Last Update Posted : January 12, 2015
Information provided by (Responsible Party):
Wendy Kinzler, MD, Winthrop University Hospital

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.

Condition or disease
Pregnancy Related Trauma Abruptio Placentae

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Fetal Fibronectin (fFN) in Predicting Preterm Delivery Due to Abruptio Placenta in Patients With Minor Maternal Trauma.
Study Start Date : October 2009
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Delivery within 2 weeks of the trauma event [ Time Frame: 2 weeks ]

Biospecimen Retention:   Samples Without DNA
Fetal fibronectin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Inclusion Criteria:

  • Singleton intrauterine pregnancy ≥20 weeks and ≤35 weeks gestational age
  • Chief complaint of minor maternal trauma including motor vehicle accident, patient fall or assault with absence of maternal conditions outlined in exclusion criteria

Exclusion Criteria:

  • 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
  • Illicit drug use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01279369

United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Principal Investigator: Wendy L. Kinzler, M.D. Winthrop University Hospital

Responsible Party: Wendy Kinzler, MD, Attending Physician, Winthrop University Hospital Identifier: NCT01279369     History of Changes
Other Study ID Numbers: 117104-4
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: January 12, 2015
Last Verified: January 2015

Keywords provided by Wendy Kinzler, MD, Winthrop University Hospital:
Placental Abruption
Fetal fibronectin

Additional relevant MeSH terms:
Wounds and Injuries
Abruptio Placentae
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases