What is the clinical evidence from this study?

Study design: RCT. Population: Pregnancy-induced hypertension and pre-eclamptic toxemia risk (n=65). Intervention: Aspirin vs. Placebo. Primary outcome: Pregnancy-induced hypertension (p=0.024).

What question did this study set out to answer?

This study aims to evaluate the effectiveness of aspirin in preventing pregnancy-induced hypertension and modifying prostaglandin metabolism.

August 10, 1989

The Use of Aspirin to Prevent Ppregnancy-Induced Hypertension and Lower the Ratio of Thromboxane A2to Prostcyclin in Relatively High Risk Pregnancies

Key Result

Low daily doses of aspirin during the third trimester significantly reduced the incidence of pregnancy-induced hypertension compared to placebo (11.8% vs 35.5%; P=0.024).

Key Points

This study aims to evaluate the effectiveness of aspirin in preventing pregnancy-induced hypertension and modifying prostaglandin metabolism.
Prospective, randomized, double-blind, placebo-controlled design.
791 pregnant women with risk factors screened; 65 women treated with aspirin or placebo.
Daily doses of 100 mg aspirin were administered during the third trimester.
Aspirin-treated women had a lower incidence of pregnancy-induced hypertension (11.8% vs. 35.5%; P = 0.024).
The incidence of pre-eclamptic toxemia was also lower in the aspirin group (2.9% vs. 22.6%; P = 0.019).
The ratio of thromboxane A2 to prostacyclin metabolites decreased by 34.7% in the aspirin group.

Study Design

Type

RCT (n=65)

Blinding

double-blind

Randomization

randomized

Structured PICO

Does low-dose aspirin prevent pregnancy-induced hypertension and pre-eclamptic toxemia in high-risk pregnant women?

Population

65 pregnant women at high risk for pre-eclamptic toxemia (identified by an abnormal rollover test at week 28 or 29 of gestation)

Intervention

Aspirin 100 mg daily during the third trimester of pregnancy

Comparator

Placebo daily during the third trimester of pregnancy

Outcome

Incidence of pregnancy-induced hypertensionhard clinical

Low daily doses of aspirin (100 mg) during the third trimester significantly reduce the incidence of pregnancy-induced hypertension and preeclampsia in high-risk women.

Main Result

Absolute Event Rate: 11.8% vs 35.5%

p-value: p=0.024

Abstract

We carried out a prospective, randomized, double-blind, placebo-controlled study to investigate the capacity of aspirin to prevent pregnancy-induced hypertension and to alter prostaglandin metabolism. A total of 791 pregnant women with various risk factors for pre-eclamptic toxemia were screened with use of the rollover test (a comparison of blood pressure before and after the woman rolls from her left side to her back) during week 28 or 29 of gestation. Of 69 women with abnormal results (an increase in blood pressure during the rollover test), 65 entered the study and were treated with a daily dose of either aspirin (100 mg; 34 women) or placebo (31 women) during the third trimester of pregnancy. The number of women in whom pregnancy-induced hypertension developed was significantly lower among the aspirin-treated than among the placebo-treated women (4 11.8 percent vs. 11 35.5 percent; P = 0.024); the same was true for the incidence of preeclamptic toxemia (1 2.9 percent vs 7 22.6 percent; P = 0.019). The mean ratio of serum levels of thromboxane A2 to serum levels of prostacyclin metabolites after three weeks of treatment decreased by 34.7 percent in the aspirin-treated group but increased by 51.2 percent in the placebo-treated group. No serious maternal or neonatal side effects of treatment occurred in either group. We conclude that low daily doses of aspirin taken during the third trimester of pregnancy significantly reduce the incidence of pregnancy-induced hypertension and pre-eclamptic toxemia in women at high risk for these disorders, possibly through the correction of an imbalance between levels of thromboxane and prostacyclin.

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