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January 25, 1997BMJOpen Access

Randomised controlled trial of aspirin and aspirin plus heparin in pregnant women with recurrent miscarriage associated with phospholipid antibodies (or antiphospholipid antibodies)

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Key result

Treatment with low dose aspirin and heparin significantly increased the rate of live births compared to aspirin alone (71% vs 42%; OR 3.37, 95% CI 1.40-8.10) in women with recurrent miscarriage.

Why the study?

Does low dose aspirin plus heparin improve the rate of live births in pregnant women with recurrent miscarriage associated with phospholipid antibodies compared to aspirin alone?

Population

90 pregnant women with a history of recurrent miscarriage and persistently positive results for phospholipid…

Comparison

Low dose aspirin and 5000 U of unfractionated… vs Low dose aspirin alone, started at positive…

Design

RCT, Randomly allocated an intervention when fetal heart activity was seen on…

Follow-up

Until delivery or miscarriage

Authors

RRRaj RaiImperial College Healthcare NHS TrustHCHannah CohenUniversity College London Hospitals NHS Foundation TrustMDManisha DaveUniversity of Nottingham

Discussion

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Implication

Supports adding heparin to aspirin for higher live births in antiphospholipid recurrent miscarriage; provides first RCT confirmation of benefit.

Study Design

Type

RCT (n=90)

Randomization

randomly allocated

Multicenter

No

Structured PICO

Does low dose aspirin plus heparin improve the rate of live births in pregnant women with recurrent miscarriage associated with phospholipid antibodies compared to aspirin alone?

P
Population
90 pregnant women (median age 33) with a history of recurrent miscarriage and persistently positive phospholipid antibodies, treated until miscarriage or 34 weeks' gestation.
I
Intervention
Low dose aspirin (75 mg daily) and 5000 U of unfractionated heparin subcutaneously 12 hourly. Aspirin started at positive urine pregnancy test, heparin added when fetal heart activity was seen on ultrasonography. Treatment stopped at miscarriage or 34 weeks' gestation.
C
Comparator
Low dose aspirin alone (75 mg daily), started at positive urine pregnancy test and continued until miscarriage or 34 weeks' gestation.
O
Outcome
Rate of live birthshard clinical

Main Result

Odds Ratio: 3.37 (95% CI 1.4–8.1)

Absolute Event Rate: 71% vs 42%

The addition of low dose heparin to low dose aspirin significantly improves the rate of live births in women with recurrent miscarriage associated with phospholipid antibodies.

Cite This Study

Rai et al. (1997) conducted an RCT in recurrent miscarriage associated with phospholipid antibodies (n=90). low dose aspirin and heparin vs. low dose aspirin alone was evaluated on Rate of live births (OR 3.37, 95% CI 1.40 to 8.10). Treatment with low dose aspirin and heparin significantly increased the rate of live births compared to aspirin alone (71% vs 42%; OR 3.37, 95% CI 1.40-8.10) in women with recurrent miscarriage.

synapsesocial.com/papers/6a5e754d67fd328bf6efe864https://doi.org/10.1136/bmj.314.7076.253
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