Trial record 3 of 237 for:    high-risk pregnancy

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Mount Sinai Hospital, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Ontario Mental Health Foundation
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00546026
First received: October 16, 2007
Last updated: October 17, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
High-Risk Pregnancy
Other: placental function assessment
Phase 1

Study Type: Interventional
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?

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 160
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546026

Contacts
Contact: Eileen P. Sloan, MD 416-586-4800 ext 8693 esloan@mtsinai.on.ca
Contact: Barbara Field 416-586-4800 ext 8325 bfield@mtsinai.on.ca

Locations
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
Investigators
Principal Investigator: Eileen P. Sloan, MD Mount Sinai Hospital, Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00546026     History of Changes
Other Study ID Numbers: Sloan01
Study First Received: October 16, 2007
Last Updated: October 17, 2007
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on July 23, 2014