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.)
Information provided by (Responsible Party):
Wendy Kinzler, MD, Winthrop University Hospital
First received: January 14, 2011
Last updated: January 9, 2015
Last verified: January 2015
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.
||Observational Model: Cohort
Time Perspective: Prospective
||The Use of Fetal Fibronectin (fFN) in Predicting Preterm Delivery Due to Abruptio Placenta in Patients With Minor Maternal Trauma.
Biospecimen Retention: Samples Without DNA
Primary Outcome Measures:
- Delivery within 2 weeks of the trauma event [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
- 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01279369
|Winthrop University Hospital
|Mineola, New York, United States, 11501 |
Winthrop University Hospital
||Wendy L. Kinzler, M.D.
||Winthrop University Hospital
No publications provided
||Wendy Kinzler, MD, Attending Physician, Winthrop University Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 14, 2011
||January 9, 2015
||United States: Institutional Review Board
Keywords provided by Winthrop University Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 03, 2015
Obstetric Labor Complications