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

This study has been terminated.
(Study no longer feasible as quantitative assessment of fFN can only be performed at one laboratory.)
Sponsor:
Information provided by (Responsible Party):
Wendy Kinzler, MD, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01279369
First received: January 14, 2011
Last updated: January 9, 2015
Last verified: January 2015
  Purpose

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
Pregnancy Related
Trauma
Abruptio Placentae

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • Delivery within 2 weeks of the trauma event [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Fetal fibronectin


Enrollment: 3
Study Start Date: October 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279369

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

No publications provided

Responsible Party: Wendy Kinzler, MD, Attending Physician, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01279369     History of Changes
Other Study ID Numbers: 117104-4
Study First Received: January 14, 2011
Last Updated: January 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
Pregnancy
Trauma
Placental Abruption
Fetal fibronectin

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

ClinicalTrials.gov processed this record on April 16, 2015