The Use of Fetal Fibronectin to Predict Delivery Due to Abruptio Placenta
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Winthrop University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Winthrop University Hospital
Information provided by:
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01279369
First received: January 14, 2011
Last updated: January 18, 2011
Last verified: January 2011
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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:
Biospecimen Retention: Samples Without DNA
Show Detailed Description
Fetal fibronectin
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2012 |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279369
Contacts
| Contact: Jolene C Muscat, M.D. | 516-663-8658 | jmuscat@winthrop.org |
| Contact: Wendy L Kinzler, M.D. | 516-663-8661 | wkinzler@winthrop.org |
Locations
| United States, New York | |
| Winthrop University Hospital | Recruiting |
| Mineola, New York, United States, 11501 | |
| Contact: Jolene C. Muscat, M.D. 516-663-8658 jmuscat@winthrop.org | |
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, M.D., 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 18, 2011 |
| 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 Wounds and Injuries Obstetric Labor Complications Pregnancy Complications Placenta Diseases |
ClinicalTrials.gov processed this record on May 22, 2013