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Meta-Analysis
. 2016 May 22;2016(5):CD000938.
doi: 10.1002/14651858.CD000938.pub2.

Induction of labour at or near term for suspected fetal macrosomia

Affiliations
Meta-Analysis

Induction of labour at or near term for suspected fetal macrosomia

Michel Boulvain et al. Cochrane Database Syst Rev. .

Update in

Abstract

Editorial note: It has been brought to the authors' attention that there may be an error in the data (Analysis 1.9). This is currently under investigation, and a correction will be made if the data are found to be incorrect. Details can be found in the comments.

Background: Women with a suspected large-for-dates fetus or a fetus with suspected macrosomia (birthweight greater than 4000 g) are at risk of operative birth or caesarean section. The baby is also at increased risk of shoulder dystocia and trauma, in particular fractures and brachial plexus injury. Induction of labour may reduce these risks by decreasing the birthweight, but may also lead to longer labours and an increased risk of caesarean section.

Objectives: To assess the effects of a policy of labour induction at or shortly before term (37 to 40 weeks) for suspected fetal macrosomia on the way of giving birth and maternal or perinatal morbidity.

Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2016), contacted trial authors and searched reference lists of retrieved studies.

Selection criteria: Randomised trials of induction of labour for suspected fetal macrosomia.

Data collection and analysis: Review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We contacted study authors for additional information. For key outcomes the quality of the evidence was assessed using the GRADE approach.

Main results: We included four trials, involving 1190 women. It was not possible to blind women and staff to the intervention, but for other 'Risk of bias' domains these studies were assessed as being at low or unclear risk of bias.Compared to expectant management, there was no clear effect of induction of labour for suspected macrosomia on the risk of caesarean section (risk ratio (RR) 0.91, 95% confidence interval (CI) 0.76 to 1.09; 1190 women; four trials, moderate-quality evidence) or instrumental delivery (RR 0.86, 95% CI 0.65 to 1.13; 1190 women; four trials, low-quality evidence). Shoulder dystocia (RR 0.60, 95% CI 0.37 to 0.98; 1190 women; four trials, moderate-quality evidence), and fracture (any) (RR 0.20, 95% CI 0.05 to 0.79; 1190 women; four studies, high-quality evidence) were reduced in the induction of labour group. There were no clear differences between groups for brachial plexus injury (two events were reported in the control group in one trial, low-quality evidence). There was no strong evidence of any difference between groups for measures of neonatal asphyxia; low five-minute infant Apgar scores (less than seven) or low arterial cord blood pH (RR 1.51, 95% CI 0.25 to 9.02; 858 infants; two trials, low-quality evidence; and, RR 1.01, 95% CI 0.46 to 2.22; 818 infants; one trial, moderate-quality evidence, respectively). Mean birthweight was lower in the induction group, but there was considerable heterogeneity between studies for this outcome (mean difference (MD) -178.03 g, 95% CI -315.26 to -40.81; 1190 infants; four studies; I(2) = 89%). In one study with data for 818 women, third- and fourth-degree perineal tears were increased in the induction group (RR 3.70, 95% CI 1.04 to 13.17).For outcomes assessed using GRADE, we based our downgrading decisions on high risk of bias from lack of blinding and imprecision of effect estimates.

Authors' conclusions: Induction of labour for suspected fetal macrosomia has not been shown to alter the risk of brachial plexus injury, but the power of the included studies to show a difference for such a rare event is limited. Also antenatal estimates of fetal weight are often inaccurate so many women may be worried unnecessarily, and many inductions may not be needed. Nevertheless, induction of labour for suspected fetal macrosomia results in a lower mean birthweight, and fewer birth fractures and shoulder dystocia. The unexpected observation in the induction group of increased perineal damage, and the plausible, but of uncertain significance, observation of increased use of phototherapy, both in the largest trial, should also be kept in mind.Findings from trials included in the review suggest that to prevent one fracture it would be necessary to induce labour in 60 women. Since induction of labour does not appear to alter the rate of caesarean delivery or instrumental delivery, it is likely to be popular with many women. In settings where obstetricians can be reasonably confident about their scan assessment of fetal weight, the advantages and disadvantages of induction at or near term for fetuses suspected of being macrosomic should be discussed with parents.Although some parents and doctors may feel the evidence already justifies induction, others may justifiably disagree. Further trials of induction shortly before term for suspected fetal macrosomia are needed. Such trials should concentrate on refining the optimum gestation of induction, and improving the accuracy of the diagnosis of macrosomia.

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Conflict of interest statement

Two of authors (MB and OI) are on one of the included trials (Boulvain 2015) and a third (JT) on another (LIBBY 1998). They were not involved in carrying out data extraction or assessing risk of bias for their own trials. Data extraction and assessment of risk of bias was for these trials was carried out by Leanne Jones and Therese Dowswell, Research Associates in the Cochrane Pregnancy and Childbirth Group.

Michel Boulvain was an invited speaker at a DIP congress on gestational diabetes and received accommodation expenses.

Therese Dowswell is employed by the University of Liverpool on an NIHR Cochrane Programme Grant (13/89/05) to work on a range of Cochrane Reviews. In the past 3 years her institution has received a grant from WHO to support her working on other Cochrane reviews. The Funders have no influence on the content or conclusions of the relevant Cochrane reviews.

Olivier Irion receives salary support from the University Hospitals of Geneva and the University of Geneva. He has received money to provide expert (extra‐) judiciary reports unrelated to this review. He has also been refunded for travel and meetings fees by his institution and the Swiss Ob‐Gyn society and received payment from the University of Geneva for teaching (around 6 hours per year) on courses provided to the Geneva Midwives school.

Figures

1
1
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
2
2
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Induction versus expectant management, Outcome 1: Caesarean section
1.2
1.2. Analysis
Comparison 1: Induction versus expectant management, Outcome 2: Instrumental delivery
1.3
1.3. Analysis
Comparison 1: Induction versus expectant management, Outcome 3: Shoulder dystocia
1.4
1.4. Analysis
Comparison 1: Induction versus expectant management, Outcome 4: Brachial plexus injury
1.5
1.5. Analysis
Comparison 1: Induction versus expectant management, Outcome 5: Fracture (any)
1.6
1.6. Analysis
Comparison 1: Induction versus expectant management, Outcome 6: Low Apgar score (5 minutes)
1.7
1.7. Analysis
Comparison 1: Induction versus expectant management, Outcome 7: Low arterial cord blood pH (< 7.10)
1.8
1.8. Analysis
Comparison 1: Induction versus expectant management, Outcome 8: Spontaneous delivery
1.9
1.9. Analysis
Comparison 1: Induction versus expectant management, Outcome 9: Third‐ and fourth‐degree perineal tears
1.10
1.10. Analysis
Comparison 1: Induction versus expectant management, Outcome 10: Perinatal mortality
1.11
1.11. Analysis
Comparison 1: Induction versus expectant management, Outcome 11: Intracranial haemorrhage
1.12
1.12. Analysis
Comparison 1: Induction versus expectant management, Outcome 12: Convulsions
1.13
1.13. Analysis
Comparison 1: Induction versus expectant management, Outcome 13: Admission to neonatal intensive care unit
1.14
1.14. Analysis
Comparison 1: Induction versus expectant management, Outcome 14: Mean birthweight (g)
1.15
1.15. Analysis
Comparison 1: Induction versus expectant management, Outcome 15: Sensitivity analysis: Mean birthweight (g)
1.16
1.16. Analysis
Comparison 1: Induction versus expectant management, Outcome 16: Non pre‐specified outcome: significant shoulder dystocia
1.17
1.17. Analysis
Comparison 1: Induction versus expectant management, Outcome 17: Non pre‐specified outcome: serious neonatal morbidity or death (composite outcome)
1.18
1.18. Analysis
Comparison 1: Induction versus expectant management, Outcome 18: Non pre‐specified outcome: use of phototherapy
1.19
1.19. Analysis
Comparison 1: Induction versus expectant management, Outcome 19: Non pre‐specified outcome: cephalohematoma

Update of

Comment in

References

References to studies included in this review

Boulvain 2015 {published and unpublished data}
    1. Boulvain M, Senat MV, Perrotin F, Winer N, Beucher G, Subtil D, et al. Induction of labour versus expectant management for large-for-date fetuses: a randomised controlled trial. Lancet 2015;385(9987):2600-5. - PubMed
    1. Boulvain M, Senat MV, Rozenberg P, Irion O. Induction of labor or expectant management for large-for-dates fetuses: a randomized controlled trial. American Journal of Obstetrics and Gynecology 2012;206(Suppl 1):S2.
    1. Boulvain M. Induce or wait for estimated macrosomia (DAME). Personal communication 2002.
    1. Rozenberg P. DAME: induction of labor or waiting for suspicion fetal macrosomia. ClinicalTrials.gov (http://clinicaltrials.gov/) [21 March 2006] 2006.
Gonen 1997 {published and unpublished data}
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    1. Gonen O, Rosen DJD, Dolfin Z, Tepper R, Markov S, Fejgin MD. Induction of labor versus expectant management in macrosomia: a randomized study. Obstetrics & Gynecology 1997;89:913-7. - PubMed
LIBBY 1998 {unpublished data only}ISRCTN98146741
    1. Kean LH. Leave alone or induce for the big baby (LIBBY). National Research Register. www.update-software.com/NRR (accessed 10 September 2000).
    1. Thornton J. Unpublished data of the LIBBY pilot (as supplied October 2006). Data on file.
Tey 1995 {published and unpublished data}
    1. Tey A, Eriksen NL, Blanco JD. A prospective randomized trial of induction versus expectant management in nondiabetic pregnancies with fetal macrosomia [abstract]. American Journal of Obstetrics and Gynecology 1995;172:293.

References to ongoing studies

Perlitz 2014 {published data only}
    1. Perlitz Y. Induction of labor versus expectant management of large for gestational age/macrosomic babies at term. a multi-center randomized trial. ClinicalTrials.gov (http://clinicaltrials.gov/) [accessed 25 February 2016] 2014.

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References to other published versions of this review

Irion 1998
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