Fetal DistressNCT00454012
Use of Intrapartum Biophysical Profile When Fetal Heart Rate Monitoring is Non-reassuring in Labor
A study testing biophysical profile in people with Fetal Distress, run by Cooper Norcross Health at 1 site in United States.
Trial summary
In this research project the investigators want to figure out whether ultrasound (a non-invasive method) can be used to assess how the fetus is doing during labor. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Distress
- What is being tested?
- biophysical profile
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Dec 2008
- Phase
- Interventional
- 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 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Spontaneous or induced labor
- Gestational ages between 35 - 42 weeks
- Singleton pregnancy
- Intrapartum non-reassuring or uninterpretable FHR tracing defined as any tracing that the Labor and Delivery obstetrician is uncomfortable about or feels does not absolutely provide fetal reassurance. Inclusive FHR patterns will be repetitive late decelerations, recurrent moderate to severe variable decelerations, reduced long or short-term variability, prolonged bradycardia (<120/min) that resolves, persistent fetal tachycardia (>160/min for >60 min,) or any other FHR patterns necessitating further fetal well being evaluation (like scalp pH or scalp stimulation).
Who cannot join
- Multiple gestation
- Gestational age < 35 weeks
- Patient denial to undergo ultrasound examination during labor
- Abnormal FHR tracing requiring stat delivery
Trial locations and contacts
1 site in 1 country.
About this study
In this research project the investigators want to figure out whether ultrasound (a non-invasive method) can be used to assess how the fetus is doing during labor.
Read the detailed description
When you are in labor, the heart beat of your fetus is monitored continuously. The normal pattern is reactive and suggests that the fetus is doing well. When the pattern is different from reactive, it is difficult to say if the fetus is doing well or not. Previous investigators have shown that even with the most worrisome fetal heart rate pattern, only 2/1000 cases would require immediate delivery. Currently, we use invasive procedures like taking a drop of blood from fetal head to further assess how the fetus is doing or just proceed with the fastest way of delivery (which could increase the risk associated with surgery). In this research project we want to figure out whether ultrasound (a non-invasive method) can be used to assess how the fetus is doing during labor.
- Conditions
- Fetal Distress
- Being tested
- biophysical profile
- Keywords
- non reassuring fetal heart rate tracing, biophysical profile, assessing fetal wellbeing
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biophysical profileProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startApr 2005
- Study completionDec 2008 (estimated)
Why it stopped: poor enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal DistressStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Investigators
- Meena Khandelwal, MD, Principal investigator, Cooper Norcross Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454012
- Sponsor's protocol ID
- 05046
- Status last verified
- Mar 2009
- First submitted
- 27 Mar 2007
- Last updated
- 10 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Manning FA, Platt LD, Sipos L. Antepartum fetal evaluation: development of a fetal biophysical profile. Am J Obstet Gynecol. 1980 Mar 15;136(6):787-95. doi: 10.1016/0002-9378(80)90457-3.
PubMed 7355965
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intrapartum Biophysical Profile When Fetal Heart Rate Monitoring is Non-reassuring in Labor
- ClinicalTrials.gov ID
- NCT00454012
- Acronym / sponsor ID
- 05046
- Conditions
- Fetal Distress
- Keywords
- non reassuring fetal heart rate tracing, biophysical profile, assessing fetal wellbeing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrolment
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Dec 2008 (estimated)
- First posted
- 29 Mar 2007 (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.
In this research project the investigators want to figure out whether ultrasound (a non-invasive method) can be used to assess how the fetus is doing during labor.
Detailed description
When you are in labor, the heart beat of your fetus is monitored continuously. The normal pattern is reactive and suggests that the fetus is doing well. When the pattern is different from reactive, it is difficult to say if the fetus is doing well or not. Previous investigators have shown that even with the most worrisome fetal heart rate pattern, only 2/1000 cases would require immediate delivery. Currently, we use invasive procedures like taking a drop of blood from fetal head to further assess how the fetus is doing or just proceed with the fastest way of delivery (which could increase the risk associated with surgery). In this research project we want to figure out whether ultrasound (a non-invasive method) can be used to assess how the fetus is doing during labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Spontaneous or induced labor
- Gestational ages between 35 - 42 weeks
- Singleton pregnancy
- Intrapartum non-reassuring or uninterpretable FHR tracing defined as any tracing that the Labor and Delivery obstetrician is uncomfortable about or feels does not absolutely provide fetal reassurance. Inclusive FHR patterns will be repetitive late decelerations, recurrent moderate to severe variable decelerations, reduced long or short-term variability, prolonged bradycardia (<120/min) that resolves, persistent fetal tachycardia (>160/min for >60 min,) or any other FHR patterns necessitating further fetal well being evaluation (like scalp pH or scalp stimulation).
Key exclusion criteria (4 listed)
- Multiple gestation
- Gestational age < 35 weeks
- Patient denial to undergo ultrasound examination during labor
- Abnormal FHR tracing requiring stat delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biophysical profile | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: poor enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2009.
- Results publication: PubMed 7355965Manning FA, Platt LD, Sipos L. Antepartum fetal evaluation: development of a fetal biophysical profile. Am J Obstet Gynecol. 1980 Mar 15;136(6):787-95. doi: 10.1016/0002-9378(80)90457-3.
Related trials for Fetal Distress
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The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
Ophthalmic Artery, Labor and Delivery
Not yet recruitingObservational study
Prediction of Intrapartum Fetal Compromise After Elective Induction of Labour
Intrapartum Fetal Distress
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Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
Fetal Hypoxia, Fetal Distress
Recruiting
The Use of Virtual Reality Glasses in Women With Premature Rupture of Membranes
Fetal Health Anxiety, Prenatal Distress
Recruiting
Maternal Oxygen Supplementation for Intrauterine Resuscitation
Fetal Distress, Fetal Hypoxia
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.
Meena Khandelwal, MD principal investigator
Cooper Norcross Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biophysical profile in people with Fetal Distress, run by Cooper Norcross Health 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 4 inclusion and 4 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 10 Nov 2009. 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: poor enrolment). 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00454012, which also lists 1 linked publication.
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 10 Nov 2009.