Does heparin improve pregnancy outcomes for women with evidence of placental dysfunction?

Does heparin improve pregnancy outcomes for women with evidence of placental dysfunction? A randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN88675588

Enrollment

102

Registered

2007-05-02

Start date

2007-03-21

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Interventions

Daily subcutaneous heparin (7500 units twice daily from randomisation [18 to 24 weeks gestation] until birth) versus standard care (no medication administered). Follow up was performed on women and t

longer term follow up may be possible subject to further successful funding.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
1. Intrauterine foetal death 2. Adverse pregnancy complications (including pre-eclampsia, preterm birth, infant small for gestational age, neonatal death) 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

Measure	Time frame
1. Adverse neonatal outcomes 2. Adverse maternal outcomes 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) 4. Placental pathology 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.	—

Measure

Time frame

1. Adverse neonatal outcomes 2. Adverse maternal outcomes 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) 4. Placental pathology 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.

—

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026