Does Mid-Gestation Placental Function Assessment Reduce Psychological Distress in Women With High-Risk Pregnancies?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00546026
Recruitment Status : Unknown
Verified October 2007 by Mount Sinai Hospital, Canada.
Recruitment status was:  Not yet recruiting
First Posted : October 18, 2007
Last Update Posted : October 18, 2007
Ontario Mental Health Foundation
Information provided by:
Mount Sinai Hospital, Canada

Brief 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). 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.

Condition or disease Intervention/treatment Phase
High-Risk Pregnancy Other: placental function assessment Phase 1

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  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Mid-Gestation Placental Function Assessment Reduce Psychological Distress in Women With High-Risk Pregnancies?

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U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Primary outcome measure is STAI - The State Trait Anxiety Inventory [ Time Frame: Cross-sectional ]

Secondary Outcome Measures :
  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. [ Time Frame: Cross-sectional ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00546026

Contact: Eileen P. Sloan, MD 416-586-4800 ext 8693
Contact: Barbara Field 416-586-4800 ext 8325

Canada, Ontario
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         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Ontario Mental Health Foundation
Principal Investigator: Eileen P. Sloan, MD Mount Sinai Hospital, Canada Identifier: NCT00546026     History of Changes
Other Study ID Numbers: Sloan01
First Posted: October 18, 2007    Key Record Dates
Last Update Posted: October 18, 2007
Last Verified: October 2007

Keywords provided by Mount Sinai Hospital, Canada:
placental function
high-risk pregnancies
psychological distress