High-Risk PregnancyPhase 1NCT00546026
Does Mid-Gestation Placental Function Assessment Reduce Psychological Distress in Women With High-Risk Pregnancies?
A Phase 1 study testing placental function assessment in people with High-Risk Pregnancy, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Women whose pregnancies are at judged to be at risk of a poor outcome from an early delivery due to medical problems such as diabetes or high blood pressure, are often very anxious during pregnancy, at least until they know they have passed the risk period of premature birth (after 8 months). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High-Risk Pregnancy
- What is being tested?
- placental function assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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
- Adult, Older adult
Who may be able to join
- Patient of maternal/fetal medicine unit Mount Sinai Hospital
- Over 18 years of age
- Able to understand the nature of the study
- Able to provide consent to participation
- Singleton pregnancy
- Normal karyotype
- No major anatomical malformations at the 19 week ultrasound
- Fluent in English
Who cannot join
- Currently suffering from a major psychiatric illness or current use of psychotropic medications
- Current illegal substance or alcohol abuse
- Presence of a significant fetal structural abnormality on the 19 week ultrasound
- Abnormal karyotype
- Multifetal pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Eileen P. Sloan, MD
Cynthia Maxwell, MD
About this study
Women whose pregnancies are at judged to be at risk of a poor outcome from an early delivery due to medical problems such as diabetes or high blood pressure, are often very anxious during pregnancy, at least until they know they have passed the risk period of premature birth (after 8 months). Anxiety itself can have a significant effect on the developing baby, on the newborn child and the mother-infant bonding process. We will use a combination of pregnancy blood tests and an ultrasound assessment to check on placental function, since placental damage is the greatest cause of poor outcome. Most women tested this way will have normal results, and so may feel reassured and do better in pregnancy than untested women. The benefits may extend after birth to mother-infant bonding, breastfeeding success and a reduced risk of postnatal depression. We will randomly select an equal number of women for testing and no testing (like tossing a coin, known as a randomized control trial) to be confident that any benefits observed are genuine. The potential benefits of our research would be substantial for the mental health of many pregnant women, for their newborn and for their children as they grow up. The tests are easy to do and would add very little in terms of a woman's and in terms of the total costs of prenatal care.
Read the detailed description
Women whose pregnancies are considered "high-risk" for medical reasons such (e.g. preeclampsia, coagulation problems), often develop anxiety because of the possibility of a poor outcome. Such anxiety can affect fetal development, neonatal wellbeing, child development and maternal mental health but it often goes unrecognized. Also, women are often reluctant to use medications during pregnancy, especially if they perceive there may be the slightest risk to the fetus. By assessing placental function at mid-pregnancy in this population, we can provide an accurate estimate of which women will develop severe complications later in the pregnancy. We propose to perform a pilot randomized control trial formally incorporating placental assessment (Doppler ultrasound of the uterine artery and reassessment of diagnostic tests done earlier in pregnancy), with one group of "high-risk" women receiving the intervention (followed by feedback). Measures of pregnancy outcome and anxiety will be compared with a control group receiving standard "high-risk" pregnancy care. Levels of anxiety will be measured throughout the pregnancy using standardized scales. We hypothesize that placental function testing will reduce the burden of anxiety for the majority of women who test negative in the placental assessment arm and that these women will have improved outcomes and measures of anxiety during and following pregnancy in comparison with untested women who perceive themselves to be at risk of pregnancy complications throughout pregnancy. We also anticipate that the outcome of the pregnancy in women in the "tested" group will be more favorable (e.g. reduced admissions of neonate to NICU).
- Conditions
- High-Risk Pregnancy
- Being tested
- placental function assessment
- Keywords
- placental function, high-risk pregnancies, psychological distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placental function assessmentOther
Formal assessment of placental function in mid-gestation by placental morphology and uterine artery Doppler at 20-22 weeks and re-interpretation of prior biochemical tests for Down's syndrome and spina bifida.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | Receive assessment of placental function Receives: Other: placental function assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure is STAI - The State Trait Anxiety Inventory
Measured: Cross-sectional
Secondary outcomes (1)
Women who undergo the placental function assessment will deliver at a later gestation age, have less complications and stillbirths than untested women. Neonates will have higher APGAR scores at 1 and 5 minutes and less likely to be admitted to the NICU.
Measured: Cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Risk PregnancyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Investigators
- Eileen P. Sloan, MD, Principal investigator, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546026
- Sponsor's protocol ID
- Sloan01
- Status last verified
- Oct 2007
- First submitted
- 16 Oct 2007
- Last updated
- 18 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Mid-Gestation Placental Function Assessment Reduce Psychological Distress in Women With High-Risk Pregnancies?
- ClinicalTrials.gov ID
- NCT00546026
- Acronym / sponsor ID
- Sloan01
- Conditions
- High-Risk Pregnancy
- Keywords
- placental function, high-risk pregnancies, psychological distress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- First posted
- 18 Oct 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.
Women whose pregnancies are at judged to be at risk of a poor outcome from an early delivery due to medical problems such as diabetes or high blood pressure, are often very anxious during pregnancy, at least until they know they have passed the risk period of premature birth (after 8 months). Anxiety itself can have a significant effect on the developing baby, on the newborn child and the mother-infant bonding process. We will use a combination of pregnancy blood tests and an ultrasound assessment to check on placental function, since placental damage is the greatest cause of poor outcome. Most women tested this way will have normal results, and so may feel reassured and do better in pregnancy than untested women. The benefits may extend after birth to mother-infant bonding, breastfeeding success and a reduced risk of postnatal depression. We will randomly select an equal number of women for testing and no testing (like tossing a coin, known as a randomized control trial) to be confident that any benefits observed are genuine. The potential benefits of our research would be substantial for the mental health of many pregnant women, for their newborn and for their children as they grow up. The tests are easy to do and would add very little in terms of a woman's and in terms of the total costs of prenatal care.
Detailed description
Women whose pregnancies are considered "high-risk" for medical reasons such (e.g. preeclampsia, coagulation problems), often develop anxiety because of the possibility of a poor outcome. Such anxiety can affect fetal development, neonatal wellbeing, child development and maternal mental health but it often goes unrecognized. Also, women are often reluctant to use medications during pregnancy, especially if they perceive there may be the slightest risk to the fetus. By assessing placental function at mid-pregnancy in this population, we can provide an accurate estimate of which women will develop severe complications later in the pregnancy. We propose to perform a pilot randomized control trial formally incorporating placental assessment (Doppler ultrasound of the uterine artery and reassessment of diagnostic tests done earlier in pregnancy), with one group of "high-risk" women receiving the intervention (followed by feedback). Measures of pregnancy outcome and anxiety will be compared with a control group receiving standard "high-risk" pregnancy care. Levels of anxiety will be measured throughout the pregnancy using standardized scales. We hypothesize that placental function testing will reduce the burden of anxiety for the majority of women who test negative in the placental assessment arm and that these women will have improved outcomes and measures of anxiety during and following pregnancy in comparison with untested women who perceive themselves to be at risk of pregnancy complications throughout pregnancy. We also anticipate that the outcome of the pregnancy in women in the "tested" group will be more favorable (e.g. reduced admissions of neonate to NICU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Other: placental function assessmentReceive assessment of placental function |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient of maternal/fetal medicine unit Mount Sinai Hospital
- Over 18 years of age
- Able to understand the nature of the study
- Able to provide consent to participation
- Singleton pregnancy
Key exclusion criteria (5 listed)
- Currently suffering from a major psychiatric illness or current use of psychotropic medications
- Current illegal substance or alcohol abuse
- Presence of a significant fetal structural abnormality on the 19 week ultrasound
- Abnormal karyotype
- Multifetal pregnancy
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 |
|---|---|---|
| placental function assessmentFormal assessment of placental function in mid-gestation by placental morphology and uterine artery Doppler at 20-22 weeks and re-interpretation of prior biochemical tests for Down's syndrome and spina bifida. | Other | Active group |
Primary outcome
Primary outcome measure is STAI - The State Trait Anxiety Inventory
Time frame: Cross-sectional
1 secondary outcome
Women who undergo the placental function assessment will deliver at a later gestation age, have less complications and stillbirths than untested women. Neonates will have higher APGAR scores at 1 and 5 minutes and less likely to be admitted to the NICU.
Time frame: Cross-sectional
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2007.
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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.
Eileen P. Sloan, MD principal investigator
Mount Sinai Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing placental function assessment in people with High-Risk Pregnancy, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Oct 2007. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eileen P. Sloan, MD (416-586-4800 ext. 8693, esloan@mtsinai.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure is STAI - The State Trait Anxiety Inventory (time frame: Cross-sectional). 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 18 Oct 2007.