Effects of induction of labour versus expectant management in women with impending post-term pregnancies: the 41 week – 42 week dilemma

BMC Pregnancy and Childbirth

Esteriek de Miranda⁸  Ben Willem J Mol⁵  Frank Vandenbussche³  Anton H van Kaam⁴  Pien M Offerhaus²  Marianne Nieuwenhuijze¹  Dokie de Bont⁶  Jannet JH Bakker⁸  Joost J Zwart⁹  Martijn A Oudijk⁷  Jeroen van Dillen³  Judit KJ Keulen⁸  Aafke Bruinsma⁸  Joep C Kortekaas^1,10 

[1] Research Center for Midwifery Science, Faculty Midwifery Education & Studies Maastricht, ZUYD University, Heerlen, the Netherlands;KNOV (Royal Dutch Organisation for Midwives), Utrecht, the Netherlands;Department of Obstetrics & Gynaecology, Radboud University Medical Center, Nijmegen, the Netherlands;Department of Neonatology, Emma Children’s Hospital, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands;The Robinson Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide 5000 SA, Australia;Midwifery practice ‘het Verloskundig Huys’, Zwolle, the Netherlands;Department of Obstetrics and Gynaecology, University Medical Center, Utrecht, the Netherlands;Department of Obstetrics and Gynaecology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands;Department of Obstetrics and Gynaecology, Deventer Hospital, Deventer, the Netherlands;Department of Obstetrics and Gynaecology, Rijnstate Hospital, Arnhem, the Netherlands

关键词: Maternal preferences;    Maternal outcome;    Perinatal outcome, neonatal outcome;    Expectant management;    Labour induced;    Pregnancy post-term;    Pregnancy prolonged;   

Others  :  1125429
DOI  :  10.1186/1471-2393-14-350

 received in 2014-06-19, accepted in 2014-07-21,  发布年份 2014

【 摘 要 】

Background

Post-term pregnancy, a pregnancy exceeding 294 days or 42 completed weeks, is associated with increased perinatal morbidity and mortality and is considered a high-risk condition which requires specialist surveillance and induction of labour. However, there is uncertainty on the policy concerning the timing of induction for post-term pregnancy or impending post-term pregnancy, leading to practice variation between caregivers. Previous studies on induction at or beyond 41 weeks versus expectant management showed different results on perinatal outcome though conclusions in meta-analyses show a preference for induction at 41 weeks. However, interpretation of the results is hampered by the limited sample size of most trials and the heterogeneity in design. Most control groups had a policy of awaiting spontaneous onset of labour that went far beyond 42 weeks, which does not reflect usual care in The Netherlands where induction of labour at 42 weeks is the regular policy. Thus leaving the question unanswered if induction at 41 weeks results in better perinatal outcomes than expectant management until 42 weeks.

Methods/design

In this study we compare a policy of labour induction at 41 + 0/+1 weeks with a policy of expectant management until 42 weeks in obstetrical low risk women without contra-indications for expectant management until 42 weeks and a singleton pregnancy in cephalic position. We will perform a multicenter randomised controlled clinical trial. Our primary outcome will be a composite outcome of perinatal mortality and neonatal morbidity. Secondary outcomes will be maternal outcomes as mode of delivery (operative vaginal delivery and Caesarean section), need for analgesia and postpartum haemorrhage (≥1000 ml). Maternal preferences, satisfaction, wellbeing, pain and anxiety will be assessed alongside the trial.

Discussion

This study will provide evidence for the management of pregnant women reaching a gestational age of 41 weeks.

Trial registration

Dutch Trial Register (Nederlands Trial Register): NTR3431. Registered: 14 May 2012.

【 授权许可】

   
2014 Kortekaas et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Organisation TWH: International Classification of Diseases (ICD)-10. 2010.
• [2]Hilder L, Costeloe K, Thilaganathan B: Prolonged pregnancy: evaluating gestation-specific risks of fetal and infant mortality. Br J Obstet Gynaecol 1998, 105(2):169-173.
• [3]Ingemarsson I, Kallen K: Stillbirths and rate of neonatal deaths in 76,761 postterm pregnancies in Sweden, 1982-1991: a register study. Acta Obstet Gynecol Scand 1997, 76(7):658-662.
• [4]Nakling J, Backe B: Pregnancy risk increases from 41 weeks of gestation. Acta Obstet Gynecol Scand 2006, 85(6):663-668.
• [5]Chantry AA: Epidemiology of prolonged pregnancy: incidence and maternal morbidity. J Gynecol Obstet Biol Reprod (Paris) 2011, 40(8):709-716.
• [6]Chantry AA, Lopez E: Fetal and neonatal complications related to prolonged pregnancy. J Gynecol Obstet Biol Reprod (Paris) 2011, 40(8):717-725.
• [7]De Los Santos-Garate AM, Villa-Guillen M, Villanueva-Garcia D, Vallejos-Ruiz ML, Murguia-Peniche MT: Network NEs. Perinatal morbidity and mortality in late-term and post-term pregnancy. NEOSANO perinatal network’s experience in Mexico. J Perinatol 2011, 31(12):789-793.
• [8]Hermus MA, Verhoeven CJ, Mol BW, de Wolf GS, Fiedeldeij CA: Comparison of induction of labour and expectant management in postterm pregnancy: a matched cohort study. J Midwifery Womens Health 2009, 54(5):351-356.
• [9]ACOG Committee Opinion No 579: Definition of term pregnancy. Obstet Gynecol 2013, 122(5):1139-1140.
• [10]Vayssiere C, Haumonte JB, Chantry A, Coatleven F, Debord MP, Gomez C, Le Ray C, Lopez E, Salomon LJ, Senat MV, Sentilhes L, Serry A, Winer N, Grandjean H, Verspyck E, Subtil D, French College of G, Obstetricians: Prolonged and post-term pregnancies: guidelines for clinical practice from the French college of gynecologists and obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol 2013, 169(1):10-16.
• [11]Haumonte JB, D’Ercole C: Prolonged pregnancy: when should surveillance be started and what should be the frequency? J Gynecol Obstet Biol Reprod (Paris) 2011, 40(8):734-746.
• [12]Senat MV: Management of post-term pregnancies: the role for AFI, biophysical score and doppler. J Gynecol Obstet Biol Reprod 2011, 40(8):785-795.
• [13]Reuss ML, Hatch MC, Susser M: Early ultrasound dating of pregnancy: selection and measurement biases. J Clin Epidemiol 1995, 48(5):667-674.
• [14]Tunon K, Eik-Nes SH, Grottum P: A comparison between ultrasound and a reliable last menstrual period as predictors of the day of delivery in 15,000 examinations. Ultrasound Obstet Gynecol 1996, 8(3):178-185.
• [15]Savitz DA, Terry JW Jr, Dole N, Thorp JM Jr, Siega-Riz AM, Herring AH: Comparison of pregnancy dating by last menstrual period, ultrasound scanning, and their combination. Am J Obstet Gynecol 2002, 187(6):1660-1666.
• [16]Cheng YW, Nicholson JM, Nakagawa S, Bruckner TA, Washington AE, Caughey AB: Perinatal outcomes in low-risk term pregnancies: do they differ by week of gestation? Am J Obstet Gynecol 2008, 199(4):370 e371-377.
• [17]Hussain AA, Yakoob MY, Imdad A, Bhutta ZA: Elective induction for pregnancies at or beyond 41 weeks of gestation and its impact on stillbirths: a systematic review with meta-analysis. BMC Public Health 2011, 11(Suppl 3):S5. BioMed Central Full Text
• [18]Gulmezoglu AM, Crowther CA, Middleton P, Heatley E: Induction of labour for improving birth outcomes for women at or beyond term. Cochrane Database Syst Rev 2012., 6CD004945
• [19]Wennerholm UB, Hagberg H, Brorsson B, Bergh C: Induction of labor versus expectant management for post-date pregnancy: is there sufficient evidence for a change in clinical practice? Acta Obstet Gynecol Scand 2009, 88(1):6-17.
• [20]Hannah ME, Hannah WJ, Hellmann J, Hewson S, Milner R, Willan A: Induction of labor as compared with serial antenatal monitoring in post-term pregnancy. A randomized controlled trial. The Canadian multicenter post-term pregnancy trial group. N Engl J Med 1992, 326(24):1587-1592.
• [21]Baud D, Rouiller S, Hohlfeld P, Tolsa JF, Vial Y: Adverse obstetrical and neonatal outcomes in elective and medically indicated inductions of labor at term. J Matern Fetal Neonatal Med 2013, 26(16):1595-1601.
• [22]Wood S, Cooper S, Ross S: Does induction of labour increase the risk of caesarean section? A systematic review and meta-analysis of trials in women with intact membranes. BJOG Inter J Obstetrics Gynaecol 2014, 121(6):674-685. discussion 85
• [23]Delaney M, Roggensack A, Leduc DC, Ballermann C, Biringer A, Dontigny L, Gleason TP, Shek-Yn Lee L, Martel MJ, Morin V, Polsky JN, Rowntree C, Shepherd DJ, Wilson K, Clinical Practice Obstetrics C, Maternal Fetal Medicine C: Guidelines for the management of pregnancy at 41 + 0 to 42 + 0 weeks. J Obstet Gynaecol Can 2008, 30(9):800-823.
• [24]SEROTINITEIT/postterm pregnancy Netherlands: Dutch Society for Obstetrics and Gynaecology (NVOG); 2007.
• [25]Ecker JL, Chen KT, Cohen AP, Riley LE, Lieberman ES: Increased risk of cesarean delivery with advancing maternal age: indications and associated factors in nulliparous women. Am J Obstet Gynecol 2001, 185(4):883-887.
• [26]Macer JA, Macer CL, Chan LS: Elective induction versus spontaneous labor: a retrospective study of complications and outcome. Am J Obstet Gynecol 1992, 166(6 Pt 1):1690-1696. discussion 1696-1697
• [27]Schuit E, Kwee A, Westerhuis ME, Van Dessel HJ, Graziosi GC, Van Lith JM, Nijhuis JG, Oei SG, Oosterbaan HP, Schuitemaker NW, Wouters MG, Visser GH, Mol BW, Moons KG, Groenwold RH: A clinical prediction model to assess the risk of operative delivery. BJOG Inter J Obstetrics Gynaecol 2012, 119(8):915-923.
• [28]Maassen MS, Hendrix MJ, Van Vugt HC, Veersema S, Smits F, Nijhuis JG: Operative deliveries in low-risk pregnancies in The Netherlands: primary versus secondary care. Birth 2008, 35(4):277-282.
• [29]Brouwers HAA, Bruins HW, van Huis AM, de Miranda E, Ravelli ACJ, Tamminga P: PRN Non-published Data. The Netherlands: Perinatal Registration Netherlands (PRN); 2013.
• [30]Brouwers HAA, Bruins HW, van Huis AM, de Miranda E, Ravelli ACJ, Tamminga P: PRN Yearbook 2010. Netherlands: Perinatal Registration Netherlands (PRN); 2010.
• [31]PRN Insight Netherlands: Perinatal Registry Netherlands (PRN); 2004-2013.
• [32]Boers KE, Vijgen SM, Bijlenga D, van der Post JA, Bekedam DJ, Kwee A, van der Salm PC, van Pampus MG, Spaanderman ME, de Boer K, Duvekot JJ, Bremer HA, Hasaart TH, Delemarre FM, Bloemenkamp KW, van Meir CA, Willekes C, Wijnen EJ, Rijken M, le Cessie S, Roumen FJ, Thornton JG, van Lith JM, Mol BW, Scherjon SA, group Ds: Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT). BMJ 2010, 341:c7087.
• [33]Koopmans CM, Bijlenga D, Groen H, Vijgen SM, Aarnoudse JG, Bekedam DJ, van den Berg PP, de Boer K, Burggraaff JM, Bloemenkamp KW, Drogtrop AP, Franx A, de Groot CJ, Huisjes AJ, Kwee A, van Loon AJ, Lub A, Papatsonis DN, van der Post JA, Roumen FJ, Scheepers HC, Willekes C, Mol BW, van Pampus MG, group Hs: Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks’ gestation (HYPITAT): a multicentre, open-label randomised controlled trial. Lancet 2009, 374(9694):979-988.
• [34]Jozwiak M, Oude Rengerink K, Benthem M, van Beek E, Dijksterhuis MG, de Graaf IM, van Huizen ME, Oudijk MA, Papatsonis DN, Perquin DA, Porath M, van der Post JA, Rijnders RJ, Scheepers HC, Spaanderman ME, van Pampus MG, de Leeuw JW, Mol BW, Bloemenkamp KW, Group PS: Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial. Lancet 2011, 378(9809):2095-2103.
• [35]Ravelli AC, Schaaf JM, Eskes M, Abu-Hanna A, de Miranda E, Mol BW: Ethnic disparities in perinatal mortality at 40 and 41 weeks of gestation. J Perinat Med 2013, 41(4):381-388.
• [36]Caughey AB, Stotland NE, Washington AE, Escobar GJ: Who is at risk for prolonged and postterm pregnancy? Am J Obstet Gynecol 2009, 200(6):e681-685.
• [37]Brouwers HAA, Bruins HW, van Huis AM, de Miranda E, Ravelli ACJ, Tamminga P: PRN Yearbook 2012. Netherlands: Perinatal Registration Netherlands (PRN); 2012.
• [38]Dutch Society for Obstetrics and Gynaecology (NVOG): SEROTINITEIT/ postterm pregnancy. 2007.
• [39]Brouwers HAA, Bruins HW, van Huis AM, de Miranda E, Ravelli ACJ, Tamminga P: PRN Yearbook 2006. Netherlands: Perinatal Registration Netherlands (PRN); 2006.
• [40]The Dutch Consortium [http://www.studies-obsgyn.nl/home/page.asp?page_id=326 webcite]
• [41]Verloskundigen Indicatie Lijst (VIL): Obstetrical Indication List. [http://www.knov.nl/uploads/knov.nl/knov_downloads/769/file/Verloskundig%20Vademecum%202003.pdf webcite]
• [42]Stevens G, Miller YD: Overdue choices: how information and role in decision-making influence women's preferences for induction for prolonged pregnancy. Birth 2012, 39(3):248-257.
• [43]Wiegers TA: The quality of maternity care services as experienced by women in the Netherlands. BMC Pregn Childbirth 2009, 9:18. BioMed Central Full Text
• [44]Arrowsmith S, Wray S, Quenby S: Maternal obesity and labour complications following induction of labour in prolonged pregnancy. BJOG Inter J Obstetrics Gynaecol 2011, 118(5):578-588.
• [45]Hoeymans N, van Lindert H, Westert GP: The health status of the Dutch population as assessed by the EQ-6D. Qual Life Res 2005, 14(3):655-663.
• [46]Spielberger CD, Vagg PR, Barker LR, Donham GW, Westberry LG: The factor structure of the state-trait anxiety inventory. Stress Anxiety 1980, 7:95-109.
• [47]Harvey S, Rach D, Stainton MC, Jarrell J, Brant R: Evaluation of satisfaction with midwifery care. Midwifery 2002, 18(4):260-267.
• [48]Sawyer A, Ayers S, Abbott J, Gyte G, Rabe H, Duley L: Measures of satisfaction with care during labour and birth: a comparative review. BMC Pregn Childbirth 2013, 13:108. BioMed Central Full Text
• [49]Gartner F: Labour and DeliverY questionnaire. 2013.
• [50]Sullivan M: Pain castastrophizing scale. Psychol Assess 1995, 7:524-532.
• [51]Wijma K, Wijma B, Zar M: Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol 1998, 19(2):84-97.
• [52]Hodnett ED, Simmons-Tropea DA: The labour agentry scale: psychometric properties of an instrument measuring control during childbirth. Res Nurs Health 1987, 10(5):301-310.
• [53]Lesaffre E: Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis 2008, 66(2):150-154.