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Meta-Analysis
. 2004 Oct 18;2004(4):CD004221.
doi: 10.1002/14651858.CD004221.pub2.

Buccal or sublingual misoprostol for cervical ripening and induction of labour

Affiliations
Meta-Analysis

Buccal or sublingual misoprostol for cervical ripening and induction of labour

G Muzonzini et al. Cochrane Database Syst Rev. .

Abstract

Background: This is one of a series of reviews of cervical ripening and labour induction using standardised methodology. Misoprostol administered by the oral and sublingual routes have the advantage of rapid onset of action, while the sublingual and vaginal routes have the advantage of prolonged activity and greatest bioavailability.

Objectives: To determine the effectiveness and safety of misoprostol administered buccally or sublingually for third trimester cervical ripening and induction of labour.

Search strategy: We searched the Cochrane Pregnancy and Childbirth Group trials register (8 December 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2003), and bibliographies of relevant papers.

Selection criteria: Randomised controlled trials comparing buccal or sublingual misoprostol used 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: A generic strategy was developed to deal with the large volume and complexity of trial data relating to labour induction. Data were extracted onto standardized forms, checked for accuracy, and analysed using RevMan software.

Main results: Three studies (502 participants) compared buccal/sublingual misoprostol respectively with a vaginal regimen (200 microg versus 50 microg) and with oral administration (50 versus 50 microg and 50 versus 100microg).The buccal route was associated with a trend to fewer caesarean sections than with the vaginal route (18/73 versus 28/79; relative risk (RR) 0.70; 95% confidence interval (CI) 0.42 to 1.15). There were no significant differences in any other outcomes. When the same dosage was used sublingually versus orally, the sublingual route was associated with less failures to achieve vaginal delivery within 24 hours (12/50 versus 19/50; RR 0.63, 95% CI 0.34 to 1.16), reduced oxytocin augmentation (17/50 versus 23/50; RR 0.74, 95% CI 0.45 to 1.21) and reduced caesarean section (8/50 versus 15/50; RR 0.53, 95% CI 0.25 to 1.14), but the differences were not statistically significant. When a smaller dose was used sublingually than orally, there were no differences in any of the outcomes.

Reviewers' conclusions: Based on only three small trials, sublingual misoprostol appears to be at least as effective as when the same dose is administered orally. There are inadequate data to comment on the relative complications and side-effects. Sublingual or buccal misoprostol should not enter clinical use until its safety and optimal dosage have been established by larger trials.

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Conflict of interest statement

None known.

Figures

1.1
1.1. Analysis
Comparison 1 Subligual/buccal vs vaginal misoprostol: all women, Outcome 1 Vaginal delivery not achieved in 24 hours.
1.2
1.2. Analysis
Comparison 1 Subligual/buccal vs vaginal misoprostol: all women, Outcome 2 Uterine hyperstimulation with fetal heart rate changes.
1.3
1.3. Analysis
Comparison 1 Subligual/buccal vs vaginal misoprostol: all women, Outcome 3 Caesarean section.
1.5
1.5. Analysis
Comparison 1 Subligual/buccal vs vaginal misoprostol: all women, Outcome 5 Serious maternal morbidity or death.
1.6
1.6. Analysis
Comparison 1 Subligual/buccal vs vaginal misoprostol: all women, Outcome 6 Cervix unfavourable/unchanged after 12‐24 hours.
1.7
1.7. Analysis
Comparison 1 Subligual/buccal vs vaginal misoprostol: all women, Outcome 7 Oxytocin augmentation.
1.10
1.10. Analysis
Comparison 1 Subligual/buccal vs vaginal misoprostol: all women, Outcome 10 Epidural analgesia.
1.11
1.11. Analysis
Comparison 1 Subligual/buccal vs vaginal misoprostol: all women, Outcome 11 Instrumental vaginal delivery.
1.13
1.13. Analysis
Comparison 1 Subligual/buccal vs vaginal misoprostol: all women, Outcome 13 Apgar score < 7 at 5 minutes.
1.14
1.14. Analysis
Comparison 1 Subligual/buccal vs vaginal misoprostol: all women, Outcome 14 Neonatal intensive care unit admission.
1.24
1.24. Analysis
Comparison 1 Subligual/buccal vs vaginal misoprostol: all women, Outcome 24 Serious maternal complication.
10.1
10.1. Analysis
Comparison 10 Subligual/buccal vs oral misoprostol: all women, Outcome 1 Vaginal delivery not achieved within 24 hours.
10.2
10.2. Analysis
Comparison 10 Subligual/buccal vs oral misoprostol: all women, Outcome 2 Uterine hyperstimulation with fetal heart rate changes.
10.3
10.3. Analysis
Comparison 10 Subligual/buccal vs oral misoprostol: all women, Outcome 3 Caesarean section.
10.6
10.6. Analysis
Comparison 10 Subligual/buccal vs oral misoprostol: all women, Outcome 6 Cervix unfavourable/unchanged after 12‐24 hours.
10.7
10.7. Analysis
Comparison 10 Subligual/buccal vs oral misoprostol: all women, Outcome 7 Oxytocin augmentation.
10.8
10.8. Analysis
Comparison 10 Subligual/buccal vs oral misoprostol: all women, Outcome 8 Uterine hyperstimulation without fetal heart rate changes.
10.10
10.10. Analysis
Comparison 10 Subligual/buccal vs oral misoprostol: all women, Outcome 10 Epidural analgesia.
10.11
10.11. Analysis
Comparison 10 Subligual/buccal vs oral misoprostol: all women, Outcome 11 Instrumental vaginal delivery.
10.13
10.13. Analysis
Comparison 10 Subligual/buccal vs oral misoprostol: all women, Outcome 13 Apgar score < 7 at 5 minutes.
10.14
10.14. Analysis
Comparison 10 Subligual/buccal vs oral misoprostol: all women, Outcome 14 Neonatal intensive care unit admission.

Update of

  • doi: 10.1002/14651858.CD004221

References

References to studies included in this review

075 Shetty 2002a {published data only}
    1. Shetty A, Mackie L, Danielian P, Rice P, Templeton A. Sublingual compared with oral misoprostol in term labour induction: a randomised controlled trial. BJOG: an international journal of obstetrics and gynaecology 2002;109:645‐50. - PubMed
075 Shetty 2002b {published data only}
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200 Carlan 2002 {published data only}
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Todd 2002 {published data only}
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References to studies awaiting assessment

Amador 2007 {published data only}
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Azeem 2006 {published data only}
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Bartusevicius 2006 {published data only}
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Caliskan 2005 {published data only}
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Elhassan 2007 {published data only}
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Esteve 2006 {published data only}
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Feitosa 2006 {published data only}
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Feitosa 2006a {published data only}
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Lo 2006 {published data only}
    1. Lo TK, Lau WL, Wong KS, Tang LC. Sublingual misoprostol compared to artificial rupture of membranes plus oxytocin infusion for labour induction in nulliparous women with a favourable cervix at term. Hong Kong Medical Journal 2006;12(5):345‐50. - PubMed
Nassar 2006 {published data only}
    1. Nassar AH. Sublingual versus vaginal misoprostol for labor induction at term (ongoing trial). ClinicalTrials.gov (http://clinicaltrials.gov/) (accessed 21 March 2006) 2006.
Nassar 2007 {published data only}
    1. Nassar AH, Awwad J, Khalil AM, Abu‐Musa A, Mehio G, Usta IM. A randomised comparison of patient satisfaction with vaginal and sublingual misoprostol for induction of labour at term. BJOG: an international journal of obstetrics and gynaecology 2007;114(10):1215‐21. - PubMed
Parisaei 2005 {published data only}
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Parisaei 2008 {published data only}
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Penaranda 2002 {published data only}
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Russell 2007 {published data only}
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Wolf 2005 {published data only}
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Hofmeyr 2003a
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Shetty 2002
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