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

NCT00546026 | Unknown Phase 1

• 1 other identifier: Sloan01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

High-Risk Pregnancy

Keywords

placental function; high-risk pregnancies; psychological distress

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure is STAI - The State Trait Anxiety Inventory

  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.

  Cross-sectional

Study Arms (1)

Active group

ACTIVE COMPARATOR

Receive assessment of placental function

Other: placental function assessment

Interventions

placental function assessment OTHER

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.

Active group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Ontario Mental Health Foundation: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Study Officials

• Eileen P. Sloan, MD

  Mount Sinai Hospital, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eileen P. Sloan, MD

CONTACT

416-586-4800; esloan@mtsinai.on.ca

Barbara Field

CONTACT

416-586-4800; bfield@mtsinai.on.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 18, 2007
• Last Updated: October 18, 2007

Record last verified: 2007-10

Locations

CA (1)