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Archives of Perinatal Medicine 19(2), 101-106, 2013 ORIGINAL PAPER Management in pregnancy after 41 weeks of gestation AGATA SZPERA-GOŹDZIEWICZ1, TOMASZ GOŹDZIEWICZ2, MARCIN RAJEWSKI5, JANA SKRZYPCZAK2, GRZEGORZ H. BRĘBOROWICZ1 Abstract Objective: The aim of this study is to evaluate pregnancy outcome after 41 weeks, depending on management: induction of labor or expectant management. Material and methods: We enrolled a total of 81 patients in 41 weeks of gestation. Simple randomization assigned 37 patients to group A (expectant management) and 44 to group B (active management). There were two protocols for clinical management: induction of labor at 41 g.a. and expectant management up to 42 g.a. Results: There were 18.18% assisted vaginal births in the case of the induction of labour compared to 2.78% of births in expectant management group (p = 0.03). The number of cesarean sections was higher in case of an expectant management, but the difference was not statistically significant. No infant was admitted to the NICU and there were no stillbirth. Conclusions: After 41 weeks of gestation in low-risk pregnancies expectant management with appropriate fetal surveillance and induction of labor seems to be the appropriate management. Key words: induction of labor, postterm pregnancy, cesarean section, stillbirth Introduction Induction of labor in developed countries is carried out in approximately 20% of pregnancies [1]. It is indicated when delivery may be beneficial to either mother or baby. Generally, it is performed in the case of postterm pregnancy (especially after 41 weeks of gestation), when continuation of pregnancy increase the risk of neonatal morbidity [2]. However, the best moment of induction remains controversial. Early induction may result in increased number of failures of the procedure and higher rate of cesarean section. On the other hand, the risk of complications for both the mother and the fetus/newborn increases with gestational age [3]. Number of induction of labor is increasing rapidly throughout the world. In the United States in 1990 it was carried out for 9.5% and in 2006 for 22.5% of all pregnancies [4]. Several independent studies showed recently that the risks of continuing pregnancy after the estimated delivery term for the fetus [5-10] and for the mother [11-15] is greater than estimated before. Perinatal mortality (defined as the intrauterine fetal death and early death of the neonates) at 42 weeks of gestation is two fold higher than at 40 weeks of gestation (4-7, respectively, compared to 2-3 per 1000 births) and four fold higher in 43 weeks of gestation and a five to seven times in 44 weeks of gestation [5-7, 16]. These studies also show that the risk of neonatal morbidity increases significantly after 40 1 2 weeks of gestation [7]. Many serious complications such as meconium aspiration syndrome, neonatal acidosis, low Apgar scores, oligohydramnios, macrosomia (which entails an increased risk of injuries during delivery), is much more common in infants born after 41 weeks of pregnancy [17, 18]. Postterm pregnancy is also an independent risk factor for neonatal encephalopathy [19] and mortality in the first year of life [5, 7]. Too little attention is often paid to the increased risk of complications in the mother in late pregnancy. This risk is associated with an increased incidence of cervical dystocia (9-12% compared to 2-7% in pregnancies at term), severe perineal trauma (third- and fourth-degree perineal laceration, resulting from the increased incidence of fetal macrosomia and operational vaginal deliveries) and cesarean section [8, 11, 12]. In addition, the pregnancy continued beyond 40 weeks is associated with an increased risk of adverse effects on the emotional state of patients such as strong anxiety and frustration [20]. On the other hand, there is a lot of data suggest that the full-term infants born between 37+ 0 weeks of gestation and 38 + 6 weeks of gestation are characterized by increased morbidity and mortality compared to full-term infants born after 38 + 6 weeks of gestation [21, 22]. The aim of the study is to evaluate the obstetrical results in pregnancies after 41 weeks, depending on the Department of Perinatology and Gynecology, Poznan University of Medical Sciences, Poland Division of Reproduction, Poznan University of Medical Sciences, Poland 102 A. Szpera-Goździewicz, T. Goździewicz, M. Rajewski, J. Skrzypczak, G.H. Bręborowicz type of management: induction of labor or expectant management. Material and methods The research was conducted at the Department of Perinatology and Gynecology and in the Division of Reproduction of Poznan University of Medical Sciences in the years 2010-2012. The study was approved by the Bioethics Committee of the Poznan University of Medical Sciences (No. 964/10). Each patient received detailed information about the study and signed an informed consent to participate in the project on a properly prepared form. Enrollment of patients was based on: 1) Determining the estimated date of birth on the basis of the date of the last menstrual period revised by CRL measurement during the first ultrasound examination (< 10 weeks gestation). 2) Assessment of general patient’s and fetus’ condition. Only low-risk pregnancies were enrolled. 3) Exclusion the patients with contraindications to induction of labor: the transverse or oblique presentation of the fetus, umbilical cord prolapse, classic caesarean section in history, placenta previa or vasa previa, suspicion of fetal macrosomia on the basis of clinical and ultrasound examination, any contraindication to vaginal delivery. Simple randomization was performed in order to classify patients into one of the clinical management protocols: 1) Active – administration gel containing prostaglandin E2 (Prepidil gel) into the vaginal vault or cervical canal or, where the cervical canal was open, put the Foley catheter. The next day, in the absence of contractile activity, induction was carried out by oxytocin intravenous infusion until the completion of delivery. 2) Expectant – waiting for spontaneous uterine contractions and observation of the patient and fetus to completed 42 weeks of gestation. In the absence of spontaneous contractile activity before the completed 42 weeks of gestation and the absence of indications for earlier delivery we implemented active management. During the observation we performed active supervision of the fetus – CTG tracing was performed four times a day, the patient was watching the fetal movements and every other day ultrasound examination with Doppler umbilical vessels and middle cerebral artery assessment and fetal biophysical profile was performed. We enrolled into the study 81 patients in 41 weeks of gestation and the same number of patients completed the study. As a result of simple randomization the group A (expectant management) consisted of 37 patients, while group B (active management) was composed of 44 pregnant women. The average age of patients in the group of expectant management was 28.97 years (SD = 4.19), and in the group of active management 29.2 years (SD = 5.07). Mean gestational age at admission of patients into the hospital in group A was 41 weeks +0.77 days (SD = 1.35), whereas in group B 41 weeks +0.45 days (SD = 1.06). The vast majority of patients were nulliparous in each group (median of parity in each group was 1 [min. 1, max. 4]) (Table 1). Each patient had gynecological bimanual examination and ultrasound on admission to the hospital. In group A median cervical dilatation was 1.0 cm (min 0, max 3), and vaginal part of the cervix was mainly short (59.46%) and in 40.54% formed, and in any case was totally effaced. In Group B, median cervical dilatation was also 1.0 cm (min 0, max 3), while the most common form of vaginal part of the cervix was short (65.12%), in 32.56% formed, and in 2.33% was totally effaced. Table 1. Patient characteristics, clinical and ultrasound examination results on admission to hospital Expectant management N = 37 Mean, median or % Active management N = 44 Mean, median or % 41 + 0.77 1.35 day 41 + 0.45 1.06 day NS Age (years) 28.97 4.19 29.2 5.07 NS Dilation (cm) 1; 0-3 1; 0-3 NS No effacement 40.54% 32.56% NS Medium effacement 59.46% 65.12% NS 0% 2.33% NS Parity Admission to hospital (g.a. + day) 1; 1-4 SD p SD 1; 1-4 NS Cervical effacement: Totally effacement USG cervical length (mm) 27.69 8.25 25.62 8.5 NS Management in pregnancy after 41 weeks of gestation The average cervical length in transvaginal ultrasound examination performed on the day of admission into the hospital was 27.69 mm (SD = 8.25) in group A and 25.62 mm (SD = 8.5) in group B. All the above features were not statistically different between groups (Table 1). The statistical analysis was based on the ShapiroWilk, Mann Whitney, two-sided Fisher and Pearson tests. The analysis was performed using STATISTICA v. 10 software. The level of statistical significance was p < 0.05. 103 Results In the group A (group of expectant management) patients delivered at mean 41 weeks + 3.87 days (SD = 0.41). Regular contractions developed spontaneously 29 patients (77%), the other 8 (23%) needed induction of labour. In 3 cases induction was necessary because of finished 42 g.a. The following 5 women had interrupted expectant management due to oligohydramnion or abnormal biophysical test result. Induction was performed at mean 41 weeks + 3.75 days (SD = 1.04). Table 2. Delivery and perinatal outcomes of pregnancies after 41 weeks of gestation depend on the management G.a. + day of delivery G.a. + day of induction of labour Induction of labour Prostaglandin E2 Prostaglandin E2 + Oxytocin Prostaglandin E2 + Foley Foley + Oxytocin Prostaglandin E2 + Foley + Oxytocin Induction of labour Expectant management (group B) N = 44 (group A) N = 37 p Mean, median or % SD or min-max Mean, median or % SD or min-max 41 + 3.87 0.41 41 + 1.97 1.62 p < 0.001 41 + 3.75 1.04 41 + 0.9 1.35 p = 0.005 23% 100% p < 0.001 37.5% 50% NS 50% 43.19% NS 12.5% 0% NS 0% 4.3% NS 0% 2.51% NS 61.11% 36.11% 2.78% 56.82% 25% 18.18% NS NS p = 0.03 Indications to operative delivery: – lack of progress of labour – symptoms of fetal distress – other 46% 46% 8% 42% 58% 0% NS NS NS Blood loss during labour (ml) 329 159 343 169 NS Birth weight (g) Male Female Ap 1’ (median, min-max) Ap 5’ (median, min-max) 3637 63.89% 36.11% 10 10 426 396 6-10 7-10 3647 52.27% 47.73% 10 10 8-10 10-10 NS NS NS NS NS pH UA BE UA pH UV BE UV 7.28 !3.88 7.33 !3.35 0,08 3.57 0.08 3.31 7.26 !4.05 7.32 !4.22 0,09 3.16 0.07 2.66 NS NS NS NS 0% 0% NS NS Spontaneous labour Cesarean section Vacuum extractor NICU admission Intrauterine fetal death 0% 0% 104 A. Szpera-Goździewicz, T. Goździewicz, M. Rajewski, J. Skrzypczak, G.H. Bręborowicz Preinduction of labour by prostaglandin E2 led to regular uterine contractions without necessity of oxytocin infusion in 37.5% (n = 3) of patients. Next 50% of patients (n = 4) needed following oxytocin infusion. The labour finished in 61.11% spontaneously, in 36.11% by cesarean section and in 2.78% by vacuum vaginal delivery. Mean blood loss was 329 ml (SD = 159 ml). Mean birth weight of infants was 3637 g (SD = 426 g), males were born more frequently (63.89%) and median Apgar score at 1 and 5 min was 10 points (1'-min 6, max 10, 5'-min 7, max 10). Acid-base balance assessed in arterial and venous cord blood after birth show table 2. The assessment of maternal total blood counts showed no significant disturbances. In one case, the puerperium was complicated by infection, which was diagnosed on the basis of clinical symptoms. In the group of active management (group B) patients delivered at mean 41 weeks + 1.97 days (SD = 1.62). Induction of labor was carried out in all of patients (which was in line with assumptions) at 41 weeks ± 0.9 days (SD = 1.35). Preinduction of labour by prostaglandin E2 led to regular uterine contractions without necessity of oxytocin infusion in 50% (n = 22) cases. In next 43.19% (n = 19) patients, following oxytocin infusion was necessary to develop contractions. The labour finished in 56.82% spontaneously, in 25% by cesarean section and in 18.18% by vacuum vaginal delivery. Mean blood loss was 343 ml (SD = 169 ml). Mean birth weight of infants was 3647 g (SD = 396 g), males were born more frequently (52,27%) and median Apgar score at 1 and 5 minute was 10 points (1'-min 8, max 10, 5'-min 10, max 10). One labour was complicated by post partum hemorrhage – patient required a transfusion of four units of PRBC and 2 units of plasma. Patients with active management delivered earlier than women with expectant management, at 41 g.a. + 1.97 days vs 41 g.a. + 3,87 days, respectively (p < 0.001). The frequency of cesarean section was higher in the group of expectant management (36.11%) than in the active management group (25%), however the difference was not statistically significant. The frequency of assisted vaginal delivery was higher in patients enrolled to active management (18.18%) than expectant one (2.78%) (p = 0.03). The indications to operative delivery were: lack of progress of labour, symptoms of fetal distress and in one case epileptic seizures. There were no differences in neonatal outcome between both groups. None of infants was admitted to neonatal intensive care unit (NICU) and there was no intrauterine fetal demise. There were no significant differences also in other factors (Table 2). Discussion Regulation of the Polish Minister of Health from 2010 obliges the obstetrician to admission of pregnant women to the hospital in 41 weeks of pregnancy [23]. What optimal procedure should be implemented in such a case, the induction of labor or waiting for spontaneous uterine contractions to 42 weeks of pregnancy? Induction of labor may be associated even with two fold higher rate of cesarean sections. In a retrospective analysis of 7804 pregnant women, induction after 41 weeks of pregnancy was performed in 1020 patients. The odds ratio of cesarean section was 2.03 at 41 weeks compared to the induction of labor performed between 37-40 weeks of gestation, and the percentage of operations reached 38.5% [24]. Different results were obtained in a study assessing the induction of labor in the Scottish population. Stock and colleagues analyzed the course of 1 271 549 pregnancies in the years 1981-2007. They compared expectant management with induction of labor at 37-41 weeks of gestation. For patients in the 41 week of pregnancy induction of labor was associated with a significantly lower percentage of cesarean and vaginal operational labours. The odds ratio of cesarean section in consequence of labor induction was 0.73 compared with expectant management procedure [25]. Cochrane Database contains a meta-analysis of 22 randomized controlled trials, which also indicates a lower rate of cesarean delivery for induction of labor (odds ratio 0.89) [26]. In our study, the percentage of cesarean delivery was also higher in the case of expectant management and amounted to 36.11%, compared to the active management (25%), but these differences were not statistically significant. The frequency of operative vaginal delivery was significantly higher in the case of induction of labor at 41 g.a. (18% vs 2.78%, p = 0.03). The main indications for operating births in each group was fetal distress and the lack of progress of labour. Expectant management, especially after 41 weeks of gestation is associated with an increased risk of perinatal mortality, which include the intrauterine death and neonatal death up to 7 day of life. The results of the Scottish population analysis indicate that waiting for spontaneous uterine contractions were significantly more often associated with perinatal mortality than for induction of labor (22% vs 7% respectively) [25]. A metaanalysis included in the Cochrane database also shows the reduction of perinatal mortality in the induction of labor (odds ratio 0.30) [26]. There was no intrauterine death of the fetus or newborn death in none of the groups we studied. Management in pregnancy after 41 weeks of gestation We can used prostaglandin E2 or a Foley catheter to preinduction of labor. Results of a randomized study analyzing 824 pregnant women (PROBAAT study) who undergo induction of labor in a median of 40 weeks of gestation did not show significant benefits of any of the above methods [28]. The results of our study indicate mainly the use of Prostaglandins E2 to preinduction of labor, which often was sufficient to induce regular uterine contractions without oxytocin infusion necessity. Recommendations of the American Society of Obstetricians and Gynecologists does not indicate the optimal management with postterm pregnancy. They allow expectant management and induction of labor. In the course of expectant management appropriate supervision should be carried out by assessing fetal CTG records, biophysical profile of the fetus and amniotic fluid volume assessment. If there is evidence of fetal distress or decreased amniotic fluid volume expectant management should be stopped and induction of labour shoud be carried out [27]. After 41 weeks of gestation in low-risk pregnancies expectant management with appropriate fetal surveillance and induction of labor seems to be the appropriate way to proceed. The decision on the method of procedure we may leave to the patient after a detailed discussion of the advantages and disadvantages of each. References [1] Mealing N.M., Roberts C.L., Ford J.B. et al. (2009) Trends in induction of labour, 1998-2007: a populationbased study. Aust. N.Z.J. Obstet. Gynaecol. 49: 599-605. [2] Gulmezoglu A.M., Crowther C.A., Middleton P. (2006) Induction of labour for improving birth outcomes for women at or beyond term. Cochrane Database Syst. Rev. 4: CD004945. [3] Norwitz E.R., Snegovskikh V.V., Caughey A.B. (2007) Prolonged pregnancy: when should we intervene? Clin. Obstet. Gynecol. 50: 547- 57. [4] Roos N., Sahlin L., Ekman-Ordeberg G. et al. (2010) Ma- ternal risk factors for postterm pregnancy and cesarean delivery following labor induction. Acta Obstet. Gynecol. 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(1997) Post-term birth: risk factors and outcomes in a 10-year cohort of Norwegian births. Obstet. Gynecol. 89: 543-8. [12] Alexander J.M., McIntire D.D., Leveno K.J. (2000) Forty weeks and beyond: pregnancy outcomes by week of gestation. Obstet. Gynecol. 98: 291-4. [13] Caughey A.B., Musci T.J. (2004) Complications of term pregnancies beyond 37 weeks of gestation. Obstet. Gy- necol. 103: 57-62. [14] Caughey A.B., Stotland N.E., Washington A.E. et al. (2007) Maternal obstetric complications of pregnancy are associated with increasing gestational age at term. Am. J. Obstet. Gynecol. 196: 155. e1-e6. [15] Caughey A.B., Bishop J. (2006) Maternal complications of pregnancy increase beyond 40 weeks of gestation in low risk women. J. Perinatol. 26: 540-5. [16] Bakketeig L.S., Bergsjo P. (1989) Post-term pregnancy: magnitude of the problem. [In:] Enkin M., Keirse M.J., Chalmers I., (eds.) Effective Care in Pregnancy and Childbirth. Oxford University Press, Oxford. [17] Doherty L., Norwitz E.R. (2008) Prolonged pregnancy: when should we intervene? Curr. Opin. Obstet. Gynecol. 20(6): 519-27. [18] Caughey A.B., Snegovskikh V.V., Norwitz E.R. (2008) Postterm pregnancy: how can we improve outcomes? Obstet. Gynecol. Surv. 63: 715-24. [19] Badawi N., Kurinczuk J.J., Keogh J.M. et al. (1998) Ante- partum risk factors for newborn encephalopathy: the Western Australian case-control study. BMJ 317: 1549 -1553. [20] Heimstad R., Romundstad P.R., Hyett J. et al. (2007) Women’s experiences and attitudes towards expectant management and induction of labor for post-term pregnancy. Acta Obstet. Gynecol. Scand. 86: 950-6. [21] Engle W.A., Kominiarek M.A. (2008) Late preterm infants, early term infants, and timing of elective deliveries. Clin. Perinatol. 35: 325-41. [22] Reddy U.M., Ko C.W., Willinger M. (2006) ‘Early’ term births (37-38 weeks) are associated with increased mortality. Am. J. Obstet. Gynecol. 195: S202. [23] Rozporządzenie Ministra Zdrowia z 23 września 2010 r. „Standardy postępowania oraz procedury medyczne przy udzielaniu świadczeń zdrowotnych z zakresu opieki okołoporodowej sprawowanej nad kobietą w okresie fizjologicznej ciąży, fizjologicznego porodu, połogu oraz opieki nad noworodkiem”. [24] Ehrenthal D.B., Jiang X., Strobino D. (2010) Labor induc- tion and the risk of a cesarean delivery among nulliparous women at term. Obstet. Gynecol.116: 35-42. [25] Stock S.J., Ferguson E., Duffy A. et al. (2012) Outcomes of elective induction of labour compared with expectant management: population based study. BMJ 344: e2838. [26] Gulmezoglu A.M., Crowther C.A., Meddleton P. (2012) Induction of labour for improving birth outcomes for 106 A. Szpera-Goździewicz, T. Goździewicz, M. Rajewski, J. Skrzypczak, G.H. Bręborowicz women at or beyond term. Cochrane Database Syst. Rev. 6: CD004945. [27] Matthew J. Neff. (2004) ACOG Releases Guidelines on Management of Post-term Pregnancy. Am. Fam. Physician. 70: 2221-5. [28] Jozwiak M., Oude Rengerink K., Benthem M. et al. (2011) Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an openlabel, randomised controlled trial. Lancet 378: 2095-103. J Agata Szpera-Goździewicz Department of Perinatology and Gynecology Poznan University of Medical Sciences 60-535 Poznań, Polna 33, Poland e-mail: [email protected]