Does heparin improve pregnancy outcomes for women with evidence of placental dysfunction?
- Conditions
- PregnancyPregnancy and Childbirthplacental dysfunctionPlacental dysfunction
- Registration Number
- ISRCTN88675588
- Lead Sponsor
- niversity of Toronto (Canada)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 102
1. Women with a singleton pregnancy at 18 to 22 weeks gestation
2. Evidence of placental dysfunction in their current pregnancy as determined by two or more of the following:
a. abnormal ultrasonographic placental morphology
b. abnormal uterine artery Doppler waveforms
c. one or more abnormal biochemical markers on first or second trimester maternal serum screening
1. Women with known positive thrombophilic screening
2. Known lethal foetal anomaly
3. Any contraindication to heparin therapy or continuation of the pregnancy (e.g., chorioamnionitis requiring delivery)
4. Clinical need for heparin therapy during pregnancy (e.g., previous venous thrombo-embolic episode)
5. Multiple pregnancy
6. Hypertension
7. Language barrier requiring official translator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Intrauterine foetal death<br>2. Adverse pregnancy complications (including pre-eclampsia, preterm birth, infant small for gestational age, neonatal death)<br><br>These will be assessed during the antenatal period (in relation to side effects of medication) and after the time of birth for birth and postpartum outcomes.
- Secondary Outcome Measures
Name Time Method 1. Adverse neonatal outcomes<br>2. Adverse maternal outcomes<br>3. Maternal quality of life and emotional wellbeing: this will be assessed at four months postpartum using standard questionnaires (the Edinburgh depression scale; the 36-item Short Form health survey [SF-36] and the Speilberger anxiety trait questionnaires)<br>4. Placental pathology<br><br>These will be assessed during the antenatal period (in relation to side effects of medication) and after the time of birth for birth and postpartum outcomes.