No registrations found.
ID
Source
Health condition
To evaluate the efficacy and safety of intermediate dose LMWH versus fixed low dose LMWH in pregnant women with a history of previous deep venous thrombosis or pulmonary embolism.
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Symptomatic DVT during pregnancy and 6 weeks postpartum;
2. Symptomatic PE during pregnancy and 6 weeks postpartum.
Secondary outcome
1. Symptomatic DVT during pregnancy until 3 months postpartum;
2. Symptomatic PE during pregnancy until 3 months postpartum.
Background summary
This is a randomized-controlled open-label trial comparing two different doses of LMWH in pregnant patients with a history of previous VTE. Both doses are recommended doses in the ACCP guidelines.
Patients enter the study as soon as a home test confirms pregnancy. LWMH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum.
Patients will be recruited by their treating physician, either an obstetrician or internist.
Study objective
Intermediate weight-adjusted dose LMWH for VTE prophylaxis in pregnant women with a previous history of VTE is more efficacious than fixed low dose LMWH without increasing bleeding risk.
Study design
1. Inclusion (visit);
2. 2 weeks after treatment (visit);
3. 20 weeks after treatment (phone or visit);
4. 30 weeks after treatment (phone or visit);
5. 1 week after delivery (phone or visit);
6. 6 weeks after delivery (phone);
7. 3 months after delivery (phone).
Intervention
Intermediate dose LMWH. Two different doses will be tested. LWMH will be administered until 6 weeks postpartum.
Low doses: Nadroparin (Fraxiparine): 2850 IE 1dd1 s.c.; dalteparin (Fragmin): 5000 IU 1dd1 s.c.; tinzaparin (Innohep): 4500 IU 1dd1 s.c.; enoxaparin (Clexane): 40 mg 1dd1 s.c.
Intermediate doses: weight adjusted according to dosing scheme in protocol.
Dept. of Vascular Medicine<br>
Meibergdreef 9, room F4-138
S.M. Bleker
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5662458
info@highlowstudie.org
Dept. of Vascular Medicine<br>
Meibergdreef 9, room F4-138
S.M. Bleker
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5662458
info@highlowstudie.org
Inclusion criteria
1. Age > 18 years;
2. Pregnancy confirmed by urinary pregnancy test;
3. Gestational age < 14 weeks since first day of last menstrual period;
4. Previous objectively confirmed VTE, either unprovoked, in the presence of use of oral contraceptives or estrogen/progestagen use, or related to pregnancy or the postpartum period, or minor risk factors (e.g. long distance travel, minor trauma).
Exclusion criteria
1. Previous VTE related to a major provoking risk factor (e.g. surgery, major trauma or plaster cast immobilisation in the 3 months prior to VTE) as the sole risk factor;
2. Indication for treatment with therapeutic dose anticoagulant therapy (e.g. treatment of acute VTE; permanent use of therapeutic anticoagulants outside of pregnancy);
3. Inability to provide informed consent;
4. Type 1 allergy to LMWH preparations;
5. Confirmed heparin-induced thrombocytopenia;
6. Renal insufficiency (creatinine clearance < 30ml/min);
7. Previous inclusion in the Highlow study (for another pregnancy).
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3731 |
| NTR-old | NTR3894 |
| CCMO | NL40326.018.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON55412 |