Pregnancy Clinical Trial
Official title:
TIPPS - Thrombophilia in Pregnancy Prophylaxis Study: A Multicentre, Multinational, Randomized Control Trial of Prophylaxis Low Molecular Weight Heparin (LMWH) in High-risk Thrombophilic Women.
The TIPPS trial seeks to determine the safety and effectiveness of low-molecular-weight heparin (LMWH), an anticoagulant, in preventing placenta mediated pregnancy complications and venous thromboembolism (VTE) in women with thrombophilia. Thus, the principal research question is: can LMWH prevent thrombosis in the leg veins, pulmonary arteries and placental vessels, thereby reducing the risk of deep vein thrombosis, pulmonary embolism (PE), intrauterine growth restriction (IUGR), preeclampsia, miscarriage and stillbirth?
TIPPS is a multicentre, multi-national open-label randomized controlled clinical trial. Two
hundred and eighty-four thrombophilic women at risk for VTE or placenta mediated pregnancy
complications will be recruited. Patients who require anticoagulant prophylaxis during this
pregnancy (as judged by the local investigator) or have participated in TIPPS before will
not be eligible for the trial.
The study consists of five periods: screening, randomization, antenatal follow-up, labour
and delivery, and the post-partum follow-up.
Eligible and consenting patients will be assigned to one of two groups (treatment or
control), stratified by gestational age at randomization: less than 8 weeks, 8 weeks +1 day
to 12 weeks , 12 weeks +1 day to 19 weeks + 6 days.
Treatment Group - Subjects randomized to the treatment group will receive daily injections
of dalteparin during the ante-natal period. They will be taught how to self-administer
sub-cutaneous injections of dalteparin 5000 International units (IU) once daily (o.d.) until
gestational week 20, then twice daily (bid) until 37 weeks gestation or onset of labour.
Control Group- Subjects randomized to control will receive identical obstetrical care and
follow-up, but no ante-natal dalteparin.
Visit Schedule Subject will be evaluated for study eligibility and once the consent has been
signed a baseline assessment will be completed. Randomization is done within 7 days of the
baseline visit.
All patients will be seen in person for the first follow-up visit 7-9 days after
randomization. Subsequent visits are based on the gestational age of the fetus and will be
as follows:
- Monthly (+/- 1 week) from gestational week 8 to 28 -
- Every 2 weeks (+/- 1 week) from gestational week 28 to 34
- Every week from gestational week 35 until delivery.
The following visits are required in-person at day 7-9 and at gestational weeks 12, 20, 28,
32 and/or 36 and at 6 weeks post-partum to coincide with safety blood draws for hematology
and biochemistry regardless of treatment allocation.
The remaining visits can be done in person or by phone calls: at gestational weeks 8, 16,
24, 30, 34, 35, 37, 38, 39 and 40. If available, results for hematology and biochemistry
done at gestational age 8, 16, 24 and 40 will be recorded.
At each visit, weight and blood pressure measurements will be recorded and all subjects will
be monitored for study progress, study outcomes, adverse events (AEs), and concomitant
medications. Subjects randomized to receive dalteparin will have their compliance assessed
through the monthly visits. Subjects will be required to complete the patient injection
diary and will be asked to bring it with them at all in-person-visits. The diary will be
collected at the completion of study participation.
Labour and delivery: outcomes and AEs will be assessed through a review of subjects' medical
records. If available, results from blood drawn for hematology and biochemistry will be
recorded. Data pertaining to the labour and delivery, as well as foetal weight and health at
birth, will be documented. For those subjects randomized to receive dalteparin, the date and
time of the last injection will be noted.
During the six-week postpartum period, all subjects will receive dalteparin 5,000 IU o.d.
for VTE prophylaxis. Subjects randomized to control will be taught to self-administer the
subcutaneous injections prior to starting their postpartum injections. Subjects will be
asked to complete the patient injection diary and to return it at the final visit. The final
study visit occurs at 6 weeks post-partum (+/- 1week) or at early termination; at this visit
study progress, study outcomes, adverse events, results from blood drawn for hematology and
biochemistry and compliance with study drug will be documented.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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