SPIN study

Question 1

Objective

Answer 1

To assess whether treatment with enoxaparin and low-dose aspirin, along with intensive pregnancy surveillance, reduces rate of pregnancy loss compared with intensive pregnancy surveillance alone in women with history of 2 or more consecutive previous
pregnancy losses

Question 2

intervention

Answer 2

either enoxaparin 40 mg subcutaneously and 75 mg of
aspirin orally once daily along with intense
pregnancy surveillance or intense pregnancy surveillance alone from random assignment until 36 weeks’ gestation

Question 3

Population

Answer 3

294 women presenting for initial antenatal care at fewer than 7 weeks’ gestation with history of 2 or more
consecutive previous pregnancy losses at
24 or fewer weeks’ gestation and no evidence of anatomic, endocrine, chromosomal, or immunologic abnormality

Question 4

Primary Outcome

Answer 4

Pregnancy loss rate

Question 5

Trial design

Answer 5

a parallel group, multicenter, randomized controlled trial was performed in the United Kingdom and New
Zealand

Question 6

Results

Answer 6

no reduction in pregnancy loss rate with antithrombotic intervention in pregnant women
with 2 or more consecutive previous pregnancy losses

Question 7

Exclusion criteria

Answer 7

(1) previous fetal loss investigations had determined that a previous loss was associated with anatomic, chromosomal, endocrine, or immunologic causes;
(2) they had a history of venous or arterial thrombosis or thrombophillic disorder
(3) they were already known to have APS
(4) at enrollment they had a history of 3 or more pregnancy losses and when screened found to have positive antibodies- giving them a diagnosis of APS
(6) they were found to have an excluding condition on booking for the current pregnancy e.g. abnormal TFTs

Furthermore, in women with a previous successful pregnancy, only those women in whom the 2 most recent pregnancies had resulted in consecutive losses were eligible for inclusion.

Question 8

Fetal surveilance offered in the trial?

Answer 8

scans every 2 weeks from the diagnosis of pregnancy until 12/40, then monthly ultrasound scans to assess fetal growth until 28/40

Question 9

Study weaknesses?

Answer 9

• Included women with 2 or more losses
• Not adequately powered to look at sub groups, for example the high risk subgroup of >3 pregnancy losses
• Didn’t evaluate aspirin and heparin separately