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New data items on pregnancy in SITS

Very limited data are available are available with regard to pregnancy or regular bleedings under thrombolysis. Demchuk (1) reports 8 cases with only one mother suffering a significant uterine bleeding complication. Leonhart et al (2) reported one own case and two earlier reports. Most achieved a good neurological recovery.

Maternal haemorrhagic complications have been reported in 8% with systemic thrombolysis across the spectrum of clinical thromboembolic complications (3). Considering the limited risk, pregnancy should not be considered an absolute contraindication. Alteplase does not cross the placenta, and studies on rats and rabbits did not find teratogenicity (2). The risk during pregnancy must be balanced against the potential of a disabled outcome without treatment (1).

Wein et al (4) described 5 subjects in the active arm of the NINDS intravenous thrombolysis trial, which were coded as actively menstruating. One subject who had a 1 year history of dysfunctional uterine bleeding required urgent artery ligation. The authors also reported a case of a woman requiring transfusion after iv thrombolysis for acute ischaemic stroke.

Pregnancy and regular bleedings can not be regarded as a absolute contraindications for thrombolysis, many women will be considered for treatment and many will be treated without knowledge of these conditions at treatment initiation. Practice and recommendations may vary throughout the world. SITS decided to document these data to support continuous evaluation of treatment safety and efficacy without issuing recommendations beyond those which may apply locally.

For all female patients between 13 and 49 years of age, questions will develop with regard to pregnancy and regular bleeding.


1. Demchuk AM. Yes, intravenous thrombolysis should be administered in pregnancy when other clinical and imaging factors are favourable. Stroke 2013; 44: 864-865

2. Leonhart G, Gaul C, Nietsch HH, Buerke M, Schleussner E. Thrombolytic therapy in pregnancy. J Thromb Thrombolysis 2006; 271-276

3. Cronin CA, Weisman CJ, Llinas RH. Stroke treatment: beyond the three-hour window and in the pregnant patient. Ann N YU Acad Sci. 2008; 43:2293-2299.

4. Wein TH, Hickenbottom SL, Morgenstern LB, Demchuk AM, Grotta JC. Safety of tissue plasminogen activatorfor acute stroke in menstruating women. Stroke 2002; 33: 2506-2508.

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