Pregnancy RelatedNCT01279369
The Use of Fetal Fibronectin to Predict Delivery Due to Abruptio Placenta
An observational study of Pregnancy Related and Trauma, run by Winthrop University Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Trauma, Abruptio Placentae
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: The Use of Fetal Fibronectin (fFN) in Predicting Preterm Delivery Due to Abruptio Placenta in Patients With Minor Maternal Trauma.
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.
Read the detailed description
Optimal care of the pregnant trauma patient requires prompt and efficient care by a multidisciplinary team to evaluate both maternal and fetal status. Approximately 7% of pregnancies are complicated by trauma and traumatic injury remains the leading cause of non-obstetric maternal death.1-3 In the case of major or life-threatening trauma in pregnancy, assessment and stabilization of maternal cardiovascular and respiratory status is paramount and management is generally dictated by standard adult advanced cardiovascular support algorithms. In contrast, the evaluation and management of minor trauma in pregnancy is variable and often provider dependent.4-7 Regardless of the clinical and laboratory evaluation performed, the universal goal is to prevent maternal injury or death and optimize pregnancy outcomes.
Maternal trauma has been associated with adverse pregnancy outcome, including preterm labor, abruptio placenta, uterine rupture and fetal death.8, 9 Traditional trauma scoring systems correlate well with the severity of maternal injury and are useful in triaging the mother; however, these scoring systems have not been predictive of adverse pregnancy outcome.10,11 Major or life-threatening maternal trauma, which includes maternal shock, head injury resulting in coma, and emergency laparotomy for maternal indications is associated with a 40-50% fetal loss rate as compared to 1-5% in pregnant women after minor trauma. The risk of preterm labor after maternal trauma is increased 2-fold and the prevalence of abruptio placenta after minor blunt abdominal trauma is reported at 8%. 3,6-9,12
Upon initial evaluation in the obstetrical triage setting, the examination of maternal trauma patients is focused on detection of impending labor or abruptio placenta. This evaluation includes detailed history of the accident, physical examination, abdominal and transvaginal ultrasound to evaluate placental location and/or evidence of placental abruption and cervical length, external uterine contraction monitoring, continuous fetal heart rate monitoring and blood tests such as CBC, blood type, coagulation profile and Kleihauer-Betke staining. Although much has been written on the subject of trauma during pregnancy, there is little concrete data on objective measures which can be used to dictate triage and management decisions. A recent study by Cahill et al.13 has advocated for review of the extensive evaluations often performed after maternal trauma, specifically minor trauma, because they determined that none of the commonly used clinical and laboratory measures are predictive of adverse outcomes. Identification of laboratory measures predictive of impending delivery due to placental abruption will potentially enable physicians to individualize triage and evaluation of the maternal trauma patient, as well as direct treatment and management.
Fetal fibronectin is an extracellular matrix protein that is normally found in the fetal membranes and decidua.14 It is essentially an adhesive glycoprotein or "glue" at the maternal-fetal interface. In a normal pregnancy, fFN is undetectable in vaginal secretions from weeks 22 to 35. Disruption of the maternal-fetal interface causes the release of fFN into cervical and vaginal secretions. Detection of fFN before the normal onset of labor is an indicator of preterm birth risk, allowing opportunity to provide appropriate intervention. According to previous studies, the clinical utility of fFN lies in its negative predictive value. In non-trauma patients, the sensitivity of fFN in predicting impending delivery (within 7 days) is greater than 90%. A negative fFN result can be used to rule out impending deliver with greater than 99% certainty.15
Because abruptio placenta secondary to maternal trauma is the result of shearing forces separating the placenta from the uterine decidua, this outcome could potentially be predicted by a positive fFN result. This study is therefore undertaken to determine if the presence of fFN in cervicovaginal secretions is predictive of impending delivery or placental abruption in patients with maternal trauma. With better knowledge of the probable outcomes following maternal trauma and using the appropriate diagnostic and therapeutic modalities, optimal care following minor maternal trauma for the pregnant patient and fetus can be provided.
- Conditions
- Pregnancy Related, Trauma, Abruptio Placentae
- Keywords
- Pregnancy, Trauma, Placental Abruption, Fetal fibronectin
- Medical subject headings
- Wounds and Injuries, Abruptio Placentae
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery within 2 weeks of the trauma event
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Quantitative assessment of fFN only able to be performed at one laboratory.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Kinzler, MD, Winthrop University Hospital
- Investigators
- Wendy L. Kinzler, M.D., Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279369
- Sponsor's protocol ID
- 117104-4
- Status last verified
- May 2018
- First submitted
- 14 Jan 2011
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Fetal Fibronectin (fFN) in Predicting Preterm Delivery Due to Abruptio Placenta in Patients With Minor Maternal Trauma.
- ClinicalTrials.gov ID
- NCT01279369
- Acronym / sponsor ID
- 117104-4
- Conditions
- Pregnancy Related, Trauma, Abruptio Placentae
- Keywords
- Pregnancy, Trauma, Placental Abruption, Fetal fibronectin
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Quantitative assessment of fFN only able to be performed at one laboratory.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Optimal care of the pregnant trauma patient requires prompt and efficient care by a multidisciplinary team to evaluate both maternal and fetal status. Approximately 7% of pregnancies are complicated by trauma and traumatic injury remains the leading cause of non-obstetric maternal death.1-3 In the case of major or life-threatening trauma in pregnancy, assessment and stabilization of maternal cardiovascular and respiratory status is paramount and management is generally dictated by standard adult advanced cardiovascular support algorithms. In contrast, the evaluation and management of minor trauma in pregnancy is variable and often provider dependent.4-7 Regardless of the clinical and laboratory evaluation performed, the universal goal is to prevent maternal injury or death and optimize pregnancy outcomes.
Maternal trauma has been associated with adverse pregnancy outcome, including preterm labor, abruptio placenta, uterine rupture and fetal death.8, 9 Traditional trauma scoring systems correlate well with the severity of maternal injury and are useful in triaging the mother; however, these scoring systems have not been predictive of adverse pregnancy outcome.10,11 Major or life-threatening maternal trauma, which includes maternal shock, head injury resulting in coma, and emergency laparotomy for maternal indications is associated with a 40-50% fetal loss rate as compared to 1-5% in pregnant women after minor trauma. The risk of preterm labor after maternal trauma is increased 2-fold and the prevalence of abruptio placenta after minor blunt abdominal trauma is reported at 8%. 3,6-9,12
Upon initial evaluation in the obstetrical triage setting, the examination of maternal trauma patients is focused on detection of impending labor or abruptio placenta. This evaluation includes detailed history of the accident, physical examination, abdominal and transvaginal ultrasound to evaluate placental location and/or evidence of placental abruption and cervical length, external uterine contraction monitoring, continuous fetal heart rate monitoring and blood tests such as CBC, blood type, coagulation profile and Kleihauer-Betke staining. Although much has been written on the subject of trauma during pregnancy, there is little concrete data on objective measures which can be used to dictate triage and management decisions. A recent study by Cahill et al.13 has advocated for review of the extensive evaluations often performed after maternal trauma, specifically minor trauma, because they determined that none of the commonly used clinical and laboratory measures are predictive of adverse outcomes. Identification of laboratory measures predictive of impending delivery due to placental abruption will potentially enable physicians to individualize triage and evaluation of the maternal trauma patient, as well as direct treatment and management.
Fetal fibronectin is an extracellular matrix protein that is normally found in the fetal membranes and decidua.14 It is essentially an adhesive glycoprotein or "glue" at the maternal-fetal interface. In a normal pregnancy, fFN is undetectable in vaginal secretions from weeks 22 to 35. Disruption of the maternal-fetal interface causes the release of fFN into cervical and vaginal secretions. Detection of fFN before the normal onset of labor is an indicator of preterm birth risk, allowing opportunity to provide appropriate intervention. According to previous studies, the clinical utility of fFN lies in its negative predictive value. In non-trauma patients, the sensitivity of fFN in predicting impending delivery (within 7 days) is greater than 90%. A negative fFN result can be used to rule out impending deliver with greater than 99% certainty.15
Because abruptio placenta secondary to maternal trauma is the result of shearing forces separating the placenta from the uterine decidua, this outcome could potentially be predicted by a positive fFN result. This study is therefore undertaken to determine if the presence of fFN in cervicovaginal secretions is predictive of impending delivery or placental abruption in patients with maternal trauma. With better knowledge of the probable outcomes following maternal trauma and using the appropriate diagnostic and therapeutic modalities, optimal care following minor maternal trauma for the pregnant patient and fetus can be provided.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (16 listed)
- Maternal shock
- Unstable vital signs
- Altered sensorium
- Head injury resulting in coma
- signs or symptoms of intraperitoneal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delivery within 2 weeks of the trauma event
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Quantitative assessment of fFN only able to be performed at one laboratory.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy L. Kinzler, M.D. principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Trauma, run by Winthrop University Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Quantitative assessment of fFN only able to be performed at one laboratory.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery within 2 weeks of the trauma event (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.