- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00546026
Does Mid-Gestation Placental Function Assessment Reduce Psychological Distress in Women With High-Risk Pregnancies?
October 17, 2007 updated by: Mount Sinai Hospital, Canada
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
160
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eileen P. Sloan, MD
- Phone Number: 8693 416-586-4800
- Email: esloan@mtsinai.on.ca
Study Contact Backup
- Name: Barbara Field
- Phone Number: 8325 416-586-4800
- Email: bfield@mtsinai.on.ca
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
-
Principal Investigator:
- Eileen P. Sloan, MD
-
Sub-Investigator:
- Cynthia Maxwell, MD
-
Sub-Investigator:
- William J. Lancee, Ph.D.
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Sub-Investigator:
- John C. Kingdom, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active group
Receive assessment of placental function
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary outcome measure is STAI - The State Trait Anxiety Inventory
Time Frame: Cross-sectional
|
Cross-sectional
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Cross-sectional
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eileen P. Sloan, MD, Mount Sinai Hospital, Canada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 16, 2007
First Submitted That Met QC Criteria
October 17, 2007
First Posted (Estimate)
October 18, 2007
Study Record Updates
Last Update Posted (Estimate)
October 18, 2007
Last Update Submitted That Met QC Criteria
October 17, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- Sloan01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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