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Antithrombotic therapy for improving maternal or infant health outcomes in women considered at risk of placental dysfunction

  • Review
  • Intervention

Authors


Abstract

Background

Pregnancy complications such as pre-eclampsia and eclampsia, intrauterine growth restriction and placental abruption are thought to have a common origin related to abnormalities in the development and function of the placenta.

Objectives

To compare, using the best available evidence, the benefits and harms of antenatal antithrombotic therapy to improve maternal or infant health outcomes in women considered at risk of placental dysfunction, when compared with other treatments, placebo or no treatment.

Search methods

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (March 2010). We updated this search on 17 July 2012 and added the results to the awaiting classification section.

Selection criteria

Randomised controlled trials comparing antenatal antithrombotic therapy (either alone or in combination with other agents) with placebo or no treatment, or any other treatment in the antenatal period to improve maternal or infant health outcomes in women considered at risk of placental dysfunction.

Data collection and analysis

Two review authors evaluated trials under consideration for appropriateness for inclusion and methodological quality without consideration of their results according to the prestated eligibility criteria. We used a fixed-effect meta-analysis for combining study data if the trials were judged to be sufficiently similar. We investigated heterogeneity by calculating I² statistic, and if this indicated a high level of heterogeneity among the trials included we used a random-effects model.

Main results

Our search strategy identified 14 reports of 10 studies for consideration, of which five met the inclusion criteria, involving 484 women. Four studies compared heparin (alone or in combination with dipyridamole) with no treatment; and one compared trapidil (triazolopyrimidine). While there were no statistically significant differences identified for the primary outcomes following heparin treatment, it was associated with a reduction in the risk of pre-eclampsia, eclampsia, and infant birthweight less than the 10th centile for gestational age.

Authors' conclusions

The review identified no significant differences for the primary outcomes perinatal mortality, preterm birth less than 34 weeks' gestation, and childhood neurodevelopmental handicap, although the number of studies and participants was small. While treatment with heparin appears promising with a reduction in pre-eclampsia, eclampsia, and infant birthweight less than the 10th centile for gestational age, the number of studies and participants included was small, and to date important information about serious adverse infant and long-term childhood outcomes is unavailable. Further research is required.

[Note: The 14 citations in the awaiting classification section of the review may alter the conclusions of the review once assessed.]

摘要

針對有胎盤功能不全風險的婦女,以抗血栓治療改善母親及嬰兒的健康

研究背景

懷孕併發症,例如子癲前症及子癲症、胎兒子宮內生長受限及胎盤剝落過早,都被認為是由胎盤的發育及功能異常所引發的。

研究目的

利用可得的最佳證據,針對有胎盤功能不全風險的婦女,比較以產前抗血栓治療和其他治療方式,安慰劑或不治療,改善母親及胎兒健康的好處和壞處。

检索方法

我們搜尋了the Cochrane Pregnancy and Childbirth Group's Trials Register (2010年3月)。

纳入标准

針對有胎盤功能不全風險的婦女,比較以產前抗血栓治療(單一治療或合併其他藥物)和安慰劑或不治療,或其他產前治療方式,改善母親或嬰兒健康的隨機對照試驗。

数据收集与分析

2位回顧作者根據預先設定的標準,不論試驗的結果,評估是否可收錄及其方法品質。我們使用固定效果整合分析,將相似的試驗數據整合。藉由計算I2 statistics檢視異質性,如果收錄的試驗有很高的異質性,則改用隨機效果模型。

主要结果

我們的搜尋策略找到的14篇報告,10篇研究列入考慮,其中5篇符合收錄標準,總共有484位女性。4篇研究以肝素(單一治療或併用dipyridamole)和無治療比較;1篇比較trapidil (triazolopyrimidine)。目前在主要結果方面,以肝素治療沒有發現統計學上的顯著差異,其和子癲前症、子癲症及嬰兒出生體重低於胎齡的第10百分位的減少有關。

作者结论

這篇回顧發現在主要結果的週產期死亡率、低於34週妊娠的早產以及孩童時期神經發育障礙上,沒有顯著的差異,雖然研究數量及參與人數都很少。雖然肝素對於子癲前症、子癲症及嬰兒出生體重低於胎齡的第10百分位的減少有幫助,研究及參與者的數量都不多,且目前沒有關於嚴重不良胎兒及長期孩童結果的數據。需要進一步的研究。

Plain language summary

Antithrombotic therapy for improving maternal or infant health outcomes in women considered at risk of placental dysfunction

Pregnancy complications such as pre-eclampsia and eclampsia, intrauterine fetal growth restriction and placental abruption are thought to be related to abnormalities in the development and function of the placenta. Treatment with heparin to prevent the development of blood clots within the placenta appears promising to prevent these complications. The number of pregnant women with pre-eclampsia, eclampsia, and infant birthweight less than the 10th centile for gestational age (a measure of low infant birth weight) was reduced. Five studies involving 484 women met the inclusion criteria for the review. Four studies compared heparin (alone or in combination with dipyridamole) with no treatment; and one compared triazolopyrimidine with placebo. For the majority of outcomes, the number of included studies and participants was small. The most commonly recognised minor side effect for women related to this treatment was skin bruising. To date important information about serious adverse infant and long-term childhood outcomes with using anti-clotting medications is unavailable. Further research is required.

概要

針對有胎盤功能不全風險的婦女,以抗血栓治療改善母親及嬰兒的健康

針對有胎盤功能不全風險的婦女,以抗血栓治療改善母親及嬰兒的健康 懷孕併發症,例如子癲前症及子癲症、胎兒子宮內生長受限及胎盤剝落過早,都被認為是由胎盤的發育及功能異常所引發的。以肝素治療,預防胎盤中血栓形成似乎可以預防這些併發症。子癲前症、子癲症及嬰兒出生體重低於胎齡(低出生體重的量度)的第10百分位都有因此減少。5篇試驗,總共484位婦女,符合本回顧的收錄標準。4篇研究以肝素(單一治療或併用dipyridamole)和無治療比較;1篇比較trapidil (triazolopyrimidine)和安慰劑。針對大部分的結果,收錄的研究極參與者都很少。接受這種治療的婦女中,最常見的輕微副作用是表皮瘀青。目前沒有關於抗血栓藥物的嚴重不良胎兒及長期孩童結果的數據。需要進一步的研究。

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