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Oestrogens alone or with amniotomy for cervical ripening or induction of labour

  • Review
  • Intervention

Authors

  • Jane Thomas,

    Corresponding author
    1. The University of Liverpool, C/o Cochrane Pregnancy and Childbirth Group, School of Reproductive and Developmental Medicine, Division of Perinatal and Reproductive Medicine, Liverpool, UK
    • Jane Thomas, C/o Cochrane Pregnancy and Childbirth Group, School of Reproductive and Developmental Medicine, Division of Perinatal and Reproductive Medicine, The University of Liverpool, First Floor, Liverpool Women's NHS Foundation Trust, Crown Street, Liverpool, L8 7SS, UK. jane_thomas@onetel.com.

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  • Anthony J Kelly,

    1. Brighton and Sussex University Hospitals NHS Trust, Department of Obstetrics and Gynaecology, Brighton, UK
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  • Josephine Kavanagh

    1. Social Science Research Unit, Evidence for Policy and Practice Information and Co-ordinating Centre, London, UK
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Abstract

Background

It is suggested that oestrogen may promote changes in cervical favourability with minimal effect on uterine activity and could be used to induce labour or prime the cervix. A variety of oestrogen preparations (infusions, gels, creams and tablets) and routes of administrations (oral, vaginal, extra-amniotic) vaginal,extra-amniotic) have been used in inpatient and outpatient settings. Oestrogen is rarely used in clinical practice. There are no commercially available preparations of oestrogen for induction and in most cases this is prepared specifically for the study.

Objectives

To determine the effectiveness and safety of oestrogens alone, or with amniotomy, for third trimester cervical ripening and induction of labour in comparison with other methods of induction of labour.

Search methods

We searched the Cochrane Pregnancy and Childbirth Group trials register (January 2008), the Cochrane Register of Controlled Trials (The Cochrane Library, Issue 4, 2007), and bibliographies of relevant papers.

Selection criteria

Randomised controlled trials comparing oestrogens for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods.

Data collection and analysis

Studies were assessed by at least two review authors.

Main results

Seven studies (465 women) were included. Only studies using oestrogens alone were identified; there were no trials of oestrogen with amniotomy. Three studies used intravaginal oestrogen, two used extra-amniotic oestrogen, one used an intravenous preparation, and one used oral tablets. Three studies were inpatient studies, one was an outpatient intervention and three did not state whether the setting was inpatient or outpatient. None of the studies reported the primary outcomes of rates of vaginal delivery not achieved in 24 hours. There were insufficient data to make any meaningful conclusions when comparing oestrogen with vaginal prostaglandin (PGE2), oxytocin alone, or extra amniotic PGF2a, as to whether oestrogen is effective in inducing labour.

There was no evidence of a difference between oestrogen and placebo in the rate of caesarean section, uterine hyperstimulation with or without fetal heart rate changes, or instrumental vaginal delivery.

Authors' conclusions

There were insufficient data to quantify the safety and effectiveness of oestrogen as an induction agent; they should only be used as part of randomised control trials as there are alternative effective options for inducting labour.

摘要

背景

單獨使用雌激素(oestrogen)或併用人工破水(amniotomy)以促進子宮頸成熟成引產

在綿羊身上的研究顯示在分娩前雌激素會增加而黃體素(progesterone)則會下降,這2種改變都會刺激產生前列腺素(prostaglandin)並可能引發分娩開始。雖然普遍認為雌激素是一種有效的促子宮頸成熟或是引產藥物,在人類身上的研究卻無法證明有類似的作用。目前臨床並沒有將雌激素當作一種引產藥物來使用,所以這篇系統性的文獻回顧應該要被視為歷史性的回顧,本篇文獻回顧為一系列利用標準化方法研究關於促子宮頸成熟和引產方法之文獻回顧中的一篇。

目標

從可取得的最佳證據中研究在懷孕第三個三月期單獨使用雌激素或併用人工破水對促子宮頸成熟和引產的效果及安全性。

搜尋策略

The Cochrane Pregnancy and Childbirth Group trials register、the Cochrane Controlled Trials Register,和相關論文的參考書目。最後一次搜尋:2001年4月。

選擇標準

(1)比較單獨使用雌激素和安慰劑/不使用藥物或其他方法用於懷孕第三個三月期促進子宮頸成熟成引產效果的隨機控制試驗;(2)隨機分配到治療組或是對照組;(3)適當地隱藏分配的結果;(4)違反分配的處理方式不足以影響結論;(5)報告臨床上有意義的結果測量;(6)根據隨機分配取得可用於分析的資料;(7)缺失的資料不足以影響結論。

資料收集與分析

已經有人發展出一套通用的策略以處理跟引產有關大量且複雜的試驗資料。它包含了一種2階段的資料選用方法。最初的資料選用都是集中處理。

主要結論

當我們將雌激素與安慰劑比較時,剖腹產率沒有差異(7.1% 比 10.3%, 相對風險 (RR)為 0.70, 95% 信賴區間(CI)為 0.30 和 .62)。發生子宮過度刺激合併或未合併胎心率改變或是器械輔助陰道產的比例也沒有差異。沒有任何研究報告24小時之內還沒陰道產出的比例或12到24小時之後子宮頸仍不成熟/未改變的比例。有關使用雌激素與前列腺素E2(PEG2)陰道投藥、前列腺素E2子宮頸內投藥、單獨使用催產素(oxytocin)或是羊膜外前列腺素F2a(PGF2a)的比較及雌激素在引產方面是否有效,目前仍沒有足夠的資料可以得到任何有意義的結論。

作者結論

關於雌激素作為引產藥物的效果,目前沒有足夠的資料可以得到任何結論

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

沒有足夠的證據指出雌激素用於促子宮頸成熟和引產方面的效用與安全性。有時候考量孕婦和胎兒的安全以人工的方法來引產是必要的。雌激素參與生產前子宮頸的成熟過程,雌激素可能會增加其他能幫助子宮頸成熟之局部荷爾蒙(前列腺素)的釋放。此文獻回顧發現沒有足夠的研究可以證實雌激素的真實作用。目前雌激素並沒有被普遍使用於促子宮頸成熟成引產,而且有證據顯示其他的藥物更為適用,因此不需要有更進一步的研究了。

Plain language summary

Oestrogens alone or with amniotomy for cervical ripening or induction of labour

There is not enough evidence, from randomised controlled trials, to show the effects and safety of oestrogen to ripen the cervix and help bring on labour.

Sometimes it is necessary to bring on labour artificially, because of safety concerns for either the pregnant woman or baby. Oestrogen is a hormone involved in the ripening of the neck of the womb (cervix) and preparing it for the birth of the baby. It is possible that oestrogen increases the release of other local hormones (prostaglandins) which help ripen the cervix. A variety of oestrogen preparations have been used (such as tablets, creams and infusions). They have been used for inductions when women are inpatients and outpatients. There is not enough research from the review of seven studies (with 465 women) to show the true effect of oestrogen. Oestrogen is not commonly used in current clinical practice as alternative agents that are known to be effective are available.

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