Does Mid-Gestation Placental Function Assessment Reduce Psychological Distress in Women With High-Risk Pregnancies?
Recruitment status was Not yet recruiting
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Does Mid-Gestation Placental Function Assessment Reduce Psychological Distress in Women With High-Risk Pregnancies?|
- Primary outcome measure is STAI - The State Trait Anxiety Inventory [ Time Frame: Cross-sectional ]
- 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 ]
Active Comparator: Active group
Receive assessment of placental function
Other: placental function assessment
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00546026
|Contact: Eileen P. Sloan, MD||416-586-4800 ext firstname.lastname@example.org|
|Contact: Barbara Field||416-586-4800 ext email@example.com|
|Mount Sinai Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator: Eileen P. Sloan, MD|
|Sub-Investigator: Cynthia Maxwell, MD|
|Sub-Investigator: William J. Lancee, Ph.D.|
|Sub-Investigator: John C. Kingdom, MD|
|Principal Investigator:||Eileen P. Sloan, MD||Mount Sinai Hospital, Canada|