Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth

  • Review
  • Intervention

Authors

  • Jodie M Dodd,

    Corresponding author
    1. The University of Adelaide, School of Paediatrics and Reproductive Health, Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia
    • Jodie M Dodd, School of Paediatrics and Reproductive Health, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Women's and Children's Hospital, 72 King William Road, Adelaide, South Australia, 5006, Australia. jodie.dodd@adelaide.edu.au.

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  • Vicki Flenady,

    1. Mater Health Services, Translating Research Into Practice (TRIP) Centre - Mater Medical Research Institute, Woolloongabba, Queensland, Australia
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  • Robert Cincotta,

    1. Mater Mothers' Hospital, Department of Maternal Fetal Medicine, South Brisbane, Queensland, Australia
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  • Caroline A Crowther

    1. The University of Adelaide, ARCH: Australian Research Centre for Health of Women and Babies, Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia
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Abstract

Background

Preterm birth is a major complication of pregnancy associated with perinatal mortality and morbidity. Progesterone for the prevention of preterm labour has been advocated.

Objectives

To assess the benefits and harms of progesterone for the prevention of preterm birth for women considered to be at increased risk of preterm birth.

Search methods

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (December 2008) and the Cochrane Central Register of Controlled Trials (The Cochrane Library 2008, Issue 1). We updated this search on 27 January 2012 and added the results to the awaiting classification section.

Selection criteria

Randomised controlled trials, in which progesterone was given for preventing preterm birth.

Data collection and analysis

Two authors independently evaluated trials for methodological quality and extracted data.

Main results

Eleven randomised controlled trials (2714 women and 3452 infants) were included.

Progesterone versus placebo for women with a past history of spontaneous preterm birth
Progesterone was associated with a statistically significant reduction in the risk of preterm birth less than 34 weeks' gestation (one study; 142 women; risk ratio (RR) 0.15; 95% confidence interval (CI) 0.04 to 0.64); preterm birth less than 37 weeks' gestation (four studies; 1255 women; RR 0.80; 95% CI 0.70 to 0.92); infant birthweight less than 2500 grams (two studies; 501 infants; RR 0.64; 95% CI 0.49 to 0.83).

Progesterone versus placebo for women with a short cervix identified on ultrasound
Progesterone was associated with a statistically significant reduction in the risk of preterm birth less than 34 weeks (one study; 250 women; RR 0.58; 95% CI 0.38 to 0.87); and neonatal sepsis (one study; 274 infants; RR 0.28; 95% CI 0.08 to 0.97).

Progesterone versus placebo for women with a multiple pregnancy
Progesterone was associated with a statistically significant reduction in the risk of antenatal tocolysis (one study; 654 women; RR 0.75; 95% CI 0.57 to 0.97).

Progesterone versus placebo for women following presentation with threatened preterm labour
Progesterone, was associated with a statistically significant reduction in the risk of preterm birth less than 37 weeks (one study; 60 women; RR 0.29; 95% CI 0.12 to 0.69), infant birthweight less than 2500 grams (one study; 70 infants; RR 0.52; 95% CI 0.28 to 0.98); and respiratory distress syndrome (one study; 70 infants; RR 0.30; 95% CI 0.11 to 0.83).

Progesterone versus placebo for women with 'other' risk factors for preterm birth
Progesterone was associated with no statistically significant differences for the reported outcomes.

Authors' conclusions

Further trials are required to assess the benefits and harms of progesterone therapy when given to women considered to be at increased risk of early birth.

[Note: The 52 citations in the awaiting classification section of the review may alter the conclusions of the review once assessed.]

摘要

背景

在產前給予黃體酮藥物以用於預防早產

早產是懷孕的主要併發症,會伴隨著讓周產兒死亡與罹病,發生率可高達6% 到10% 。有人提倡給予黃體酮(progesterone)藥物以用於預防早產。

目標

針對在懷孕期間預防早產發生,要評估給予黃體酮藥物的優點及危險。

搜尋策略

我們搜尋了the Cochrane Pregnancy and Childbirth Group's Specialised Register of Controlled Trials(2005年三月)、the Cochrane Central Register of Controlled Trials (The Cochrane Library,Issue 3,2004年)、MEDLINE(1965年到2005年一月)、EMBASE(1988年到2004年八月),以及Current Contents(1997年到2004年八月)。

選擇標準

所有已發表與未發表的隨機對照試驗之中,針對預防早產來給予黃體酮藥物,任何途徑用藥皆可。

資料收集與分析

當中使用的是the Cochrane Collaboration以及the Cochrane Pregnancy and Childbirth Group裡面的標準方法。有兩位作者獨立評估了方法的品質,並擷取出試驗的資料。結果的部分則是用相對風險與95% 信賴區間來呈現。

主要結論

針對所有接受黃體酮給藥的婦女們來說,少於37周的早產(6份研究 88個婦女, 相對風險(RR)0.65, 95% 信賴區間(CI)0.54 to 0.79)與少於34周的早產(1份研究, 142個婦女, RR 0.15, 95% CI 0.04 to 0.64),在風險方面有下降的現象。對於母親有接受黃體酮給藥的嬰兒來說,比較不會有體重低於2500克(4份研究, 763個嬰兒 R 0.63, 95% CI 0.49 to 0.81)或是腦室內出血(intraventricular haemorrhage)(1份研究, 458個嬰兒 R 0.25, 95% CI 0.08 to 0.82)的現象。在接受黃體酮給藥與接受安慰劑給藥的婦女們之間(5份研究, 921 個婦女, RR 0.66, 95% CI 0.37 to 1.19),周產兒死亡率並沒有不同。對於母體與新生兒的其他狀況來說,並沒有報告指出會有什麼的差異。

作者結論

肌肉注射黃體酮會讓少於37周孕期之早產的風險降低,而且嬰兒體重低於2500克的比例也會降低。然而,到目前為止,有關於其他重要的母體與嬰兒預後方面,都沒有充份的報告,而且大多數的預後都僅僅是由某組單一的試驗所提出(2003年的Meis)。關於孕期的延長,是否可以轉譯成為讓母體之健康與嬰兒長期之健康狀況獲得改善,目前還不清楚。同樣地,針對使用黃體酮療法來預防早產,有關於潛在危險方面的資訊還是不夠的。關於使用陰道型的黃體酮來預防早產,還需要有更進一步的資訊。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

針對早產高風險之中的婦女,還沒有足夠的證據支持是否要在懷孕期間使用黃體酮。在37週之前就出生的嬰兒,尤其是那些還不滿34週就出生的嬰兒,出生後都處於承受痛苦的高風險。黃體酮是一種荷爾蒙,可以抑制子宮收縮,也可以維持妊娠。本篇試驗的回顧發現,有給予黃體酮(在某些研究中,採取肌肉注射的方式,而在另外1研究中,則是置入陰道的栓劑),會產生有利的效用,包含延長懷孕的時間,但是關於潛在的危險則缺乏充足的資訊。進一步的研究還在進行當中。

Plain language summary

Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth

Babies who are born before 37 weeks, and particularly those born before 34 weeks, are at greater risk of suffering problems at birth. Progesterone is a hormone that inhibits the uterus from contracting and is involved in maintaining pregnancy. The review of eleven randomised controlled trials, involving a total of 2714 women and 3452 infants, found that where progesterone was given (by injection into the muscle in some studies and as a pessary into the vagina in others), there were some beneficial effects, including prolonging the pregnancy, but there is insufficient information about other possible benefits or harms. Further research is being undertaken.

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