CONDISOX- continued versus discontinued oxytocin stimulation of induced labour in a double-blind randomised controlled trial.

BACKGROUND: Oxytocin is an effective drug for induction of labour, but is associated with serious adverse effects of which uterine tachysystole, fetal distress and the need of immediate delivery are the most common. Discontinuation of oxytocin once the active phase of labour is established could reduce the adverse effects. The objective is to investigate how the caesarean section rate is affected when oxytocin stimulation is discontinued in the active phase of labour compared to labours where oxytocin is continued. METHODS: CONDISOX is a double-blind multicentre randomised controlled trial conducted at Danish and Dutch Departments of Obstetrics and Gynaecology. The first participant was recruited on April 8 2016. Based on a clinically relevant relative reduction in caesarean section rate of 7%, an alpha of 0.05, a beta of 80%, we aim for 1200 participating women (600 in each arm). The CONDISOX trial includes women at a gestational age of 37-42 complete weeks of pregnancy, who have uterine activity stimulated with oxytocin infusion for the induction of labour. Women are randomised when the active phase of labour becomes established, to study medication containing either oxytocin (continuous group) or placebo (discontinued group) infusion. Women are stratified by birth site, indication for oxytocin stimulation (induction of labour, prelabour rupture of membranes) and parity (nulliparous, parous +/- previous caesarean section). We will compare the primary outcome, caesarean section rate, in the two groups using a chi-square test with a p-value of 0.05. If superiority is not demonstrated, we have a pre-defined post hoc non-inferiority boundary (margin, delta) at 1.09. Secondary outcomes include duration of the active phase of labour, incidence of uterine tachysystole, postpartum haemorrhage, admission to the neonatal intensive care unit, Apgar score, umbilical arterial blood pH, and birth experience. DISCUSSION: The high frequency of oxytocin use and the potential risks of both maternal and fetal adverse effects of oxytocin emphasise the need to determine the optimal oxytocin regime for induction of labour. TRIAL REGISTRATION: NCT02553226 (registered September 17, 2015). Eudra-CT number: 2015-002942-30.

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

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.

Potential improvement of pregnancy outcome through prenatal small for gestational age detection. [correction].

OBJECTIVE: To assess differences in mode of delivery and pregnancy outcome between prenatally detected and nonprenatally detected small for gestational age (SGA) neonates born at term. STUDY DESIGN: We performed a retrospective multicenter cohort study. All singleton infants, born SGA in cephalic position between 36(0/7) and 41(0/7) weeks gestation, were classified as either prenatally detected SGA or nonprenatally detected SGA. With propensity score matching we created groups with comparable baseline characteristics. We compared these groups for composite adverse perinatal outcome, labor induction, and cesarean section rates. RESULTS: We included 718 SGA infants, of whom 555 (77%) were not prenatally detected. Composite adverse neonatal outcome did not differ statistically significant between the matched prenatally detected and the nonprenatally detected group (5.5 vs. 7.4%, odds ratio [OR] 0.74, 95% confidence interval [CI]: 0.30-1.8). However, perinatal mortality only occurred in the nonprenatally detected group (1.8% [3/163] in the matched cohort, 1.3% [7/555] in the complete cohort). In the propensity matched prenatally detected SGA group both induction of labor (57 vs. 9%, OR 14.0, 95% CI: 7.4-26.2) and cesarean sections (20 vs. 8%, OR 2.9, 95% CI: 1.5-5.8) were more often performed compared with the nonprenatally detected SGA group. CONCLUSION: Prenatal SGA detection at term allows timely induction of labor and cesarean sections thus potentially preventing stillbirth.

Outcomes after internal versus external tocodynamometry for monitoring labor.

BACKGROUND: It has been hypothesized that internal tocodynamometry, as compared with external monitoring, may provide a more accurate assessment of contractions and thus improve the ability to adjust the dose of oxytocin effectively, resulting in fewer operative deliveries and less fetal distress. However, few data are available to test this hypothesis. METHODS: We performed a randomized, controlled trial in six hospitals in The Netherlands to compare internal tocodynamometry with external monitoring of uterine activity in women for whom induced or augmented labor was required. The primary outcome was the rate of operative deliveries, including both cesarean sections and instrumented vaginal deliveries. Secondary outcomes included the use of antibiotics during labor, time from randomization to delivery, and adverse neonatal outcomes (defined as any of the following: an Apgar score at 5 minutes of less than 7, umbilical-artery pH of less than 7.05, and neonatal hospital stay of longer than 48 hours). RESULTS: We randomly assigned 1456 women to either internal tocodynamometry (734) or external monitoring (722). The operative-delivery rate was 31.3% in the internal-tocodynamometry group and 29.6% in the external-monitoring group (relative risk with internal monitoring, 1.1; 95% confidence interval [CI], 0.91 to 1.2). Secondary outcomes did not differ significantly between the two groups. The rate of adverse neonatal outcomes was 14.3% with internal monitoring and 15.0% with external monitoring (relative risk, 0.95; 95% CI, 0.74 to 1.2). No serious adverse events associated with use of the intrauterine pressure catheter were reported. CONCLUSIONS: Internal tocodynamometry during induced or augmented labor, as compared with external monitoring, did not significantly reduce the rate of operative deliveries or of adverse neonatal outcomes. (Current Controlled Trials number, ISRCTN13667534; Netherlands Trial number, NTR285.)

Morning versus evening induction of labour for improving outcomes.

BACKGROUND: Induction of labour is a common intervention in obstetric practice. Traditionally, in most hospitals induction of labour with medication starts early in the morning, with the start of the working day for the day shift. In human and animal studies spontaneous onset of labour is proven to have a circadian rhythm with a preference for start of labour in the evening. Moreover, when spontaneous labour starts in the evening, the total duration of labour and delivery shortens and fewer obstetric interventions are needed. Based on these observations one might assume that starting induction of labour in the evening, in harmony with the circadian rhythm of natural birth, is more beneficial for both mother and child. OBJECTIVES: To assess whether induction of labour starting in the evening, coinciding with the endogenous circadian rhythm, improves the outcome of labour compared with induction of labour starting in the early morning, organised to coincide with office hours. SEARCH METHODS: We contacted the Trials Search Co-ordinator to search the Cochrane Pregnancy and Childbirth Group's Trials Register (28 February 2012). In addition, we searched MEDLINE (1966 to 16 February 2012) and EMBASE (1980 to 16 February 2012). SELECTION CRITERIA: We included all published and unpublished randomised controlled trials. We excluded trials that employed quasi-random methods of treatment allocation. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias. Two review authors independently extracted data. Data were checked for accuracy. Where necessary, we contacted study authors for additional information. MAIN RESULTS: The search resulted in 2693 articles that we screened on title and abstract for eligibility.Thirteen studies were selected for full text assessment. We included three randomised trials involving 1150 women. Two trials compared the administration of prostaglandins in the morning versus the evening in women with an unfavourable cervix, and one trial compared induction of labour in the morning versus the evening in women with a favourable cervix and/or ruptured membranes with intravenous oxytocin. Because of the different mechanism, we have reported results for these two comparisons separately.In the two trials comparing prostaglandins in the morning versus the evening there were few clinically significant differences between study groups for maternal or neonatal outcomes. One study reported a statistically significant preference by women to start induction of labour with prostaglandins in the morning.In the trial examining induction of labour with intravenous oxytocin, the number of neonatal admissions was statistically significantly increased in the group of women that started induction in the morning. This finding was unexpected, and while the trial authors offered some possible explanations for this, it is important that any future trials examine neonatal outcomes. AUTHORS' CONCLUSIONS: Taking into account women's preferences that favoured administration of prostaglandins in the morning, we conclude that caregivers should preferably consider administering prostaglandins in the morning.There is no strong evidence that induction of labour with intravenous oxytocin in the evening is more or less effective than induction in the morning. Consideration may be given to start induction of labour with oxytocin in the evening when indicated.

Internal versus external tocodynamometry during induced or augmented labour.

BACKGROUND: Uterine contractions can be registered by external tocodynamometry (ET) or, after rupture of the membranes, by internal tocodynamometry (IT). Monitoring of the frequency of contractions is important especially when intravenous oxytocin is used as excessive uterine activity (hyperstimulation or tachysystole) can cause fetal distress. During induction of labour as well as during augmentation with intravenous oxytocin, some clinicians choose to monitor frequency and strength of contractions with IT rather than with ET as an intrauterine pressure catheter measures intrauterine activity more accurately than an extra-abdominal tocodynamometry device. However, insertion of an intrauterine catheter has higher costs and also potential risks for mother and child. OBJECTIVES: To assess the effectiveness of IT compared with using ET when intravenous oxytocin is used for induction or augmentation of labour. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2013) and PubMed (1966 to 6 April 2013). SELECTION CRITERIA: We included all published randomised controlled trials with data from women in whom IT was compared with ET in induced or augmented labour with oxytocin. We excluded trials that employed quasi-randomised methods of treatment allocation. We found no unpublished or ongoing studies on this subject. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial eligibility and risk of bias, and independently extracted data. Data were checked for accuracy. Where necessary, we contacted study authors for additional information. MAIN RESULTS: Three studies involving a total of 1945 women were included. Overall, risk of bias across the three trials was mixed. No serious complications were reported in the trials and no neonatal or maternal deaths occurred. The neonatal outcome was not statistically different between groups: Apgar score less than seven at five minutes (RR 1.78, 95% CI 0.83 to 3.83; three studies, n = 1945); umbilical artery pH less than 7.15 (RR 1.31, 95% CI 0.95 to 1.79; one study, n = 1456); umbilical artery pH less than 7.16 (RR 1.23, 95% CI 0.39 to 3.92; one study, n = 239); admission to the neonatal intensive care unit (RR 0.34, 95% CI 0.07 to 1.67; two studies, n = 489); and more than 48 hours hospitalisation (RR 0.92, 95% CI 0.71 to 1.20; one study, n = 1456). The pooled risk for instrumental delivery (including caesarean section, ventouse and forceps extraction) was not statistically significantly different (RR 1.05, 95% CI 0.91 to 1.21; three studies, n = 1945). Hyperstimulation was reported in two studies (n = 489), but there was no statistically significant difference between groups (RR 1.21, 95% CI 0.78 to 1.88). AUTHORS' CONCLUSIONS: This review found no differences between the two types of monitoring (internal or external tocodynamometry) for any of the maternal or neonatal outcomes. Given that this review is based on three studies (N = 1945 women) of moderate quality, there is insufficient evidence to recommend the use of one form of tocodynamometry over another for women where intravenous oxytocin was administered for induction or augmentation of labour.

Internal versus external tocodynamometry during induced or augmented labour.

BACKGROUND: Uterine contractions can be registered by external tocodynamometry (ET) or, after rupture of the membranes, by internal tocodynamometry (IT). Monitoring of the frequency of contractions is important especially when intravenous oxytocin is used as excessive uterine activity (hyperstimulation or tachysystole) can cause fetal distress. During induction of labour as well as during augmentation with intravenous oxytocin, some clinicians choose to monitor frequency and strength of contractions with IT rather than with ET as an intrauterine pressure catheter measures intrauterine activity more accurately than an extra-abdominal tocodynamometry device. However, insertion of an intrauterine catheter has higher costs and also potential risks for mother and child. OBJECTIVES: To assess the effectiveness of IT compared with using ET when intravenous oxytocin is used for induction or augmentation of labour. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (11 April 2012) and PubMed (1966 to 7 March 2012). SELECTION CRITERIA: We included all published randomised controlled trials with data from women in whom IT was compared with ET in induced or augmented labour with oxytocin. We excluded trials that employed quasi-randomised methods of treatment allocation. We found no unpublished or ongoing studies on this subject. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial eligibility and risk of bias, and independently extracted data. Data were checked for accuracy. Where necessary, we contacted study authors for additional information. MAIN RESULTS: Three studies involving a total of 1945 women were included. Overall, risk of bias across the three trials was mixed. No serious complications were reported in the trials and no neonatal or maternal deaths occurred. The neonatal outcome was not statistically different between groups: Apgar score less than seven at five minutes (RR 1.78, 95% CI 0.83 to 3.83; three studies, n = 1945); umbilical artery pH less than 7.15 (RR 1.31, 95% CI 0.95 to 1.79; one study, n = 1456); umbilical artery pH less than 7.16 (RR 1.23, 95% CI 0.39 to 3.92; one study, n = 239); admission to the neonatal intensive care unit (RR 0.34, 95% CI 0.07 to 1.67; two studies, n = 489); and more than 48 hours hospitalisation (RR 0.92, 95% CI 0.71 to 1.20; one study, n = 1456). The pooled risk for instrumental delivery (including caesarean section, ventouse and forceps extraction) was not statistically significantly different (RR 1.05, 95% CI 0.91 to 1.21; three studies, n = 1945). Hyperstimulation was reported in two studies (n = 489), but there was no statistically significant difference between groups (RR 1.21, 95% CI 0.78 to 1.88). AUTHORS' CONCLUSIONS: This review found no differences between the two types of monitoring (internal or external tocodynamometry) for any of the maternal or neonatal outcomes. Given that this review is based on three studies (N = 1945 women) of moderate quality, there is insufficient evidence to recommend the use of one form of tocodynamometry over another for women where intravenous oxytocin was administered for induction or augmentation of labour.

Women's experiences with vaginal examinations during labor in the Netherlands.

INTRODUCTION: Vaginal digital examination (VE) is a routine medical procedure during labor to assess the start and progression of labor. This study explores women's experiences with VE's during labor in the Netherlands. METHODS: An exploratory anonymous online survey was distributed among Dutch women who underwent a trial of labor and gave birth to a living term child in the previous six months. Unadjusted odds ratios are calculated to establish associations between women's characteristics and reporting a negative experience with VE's. RESULTS: Of the 159 women who met the inclusion criteria, 56 women (35.2%) reported a negative experience with the VE. These women reported more pain, embarrassment, not being able to relax, not feeling respected and not feeling the possibility to stop the examination. The odds of reporting negative experiences increased by giving birth in hospital, an instrumental delivery, more examinations, more different caretakers performing the examination and caregivers not introducing themselves before the examination. About 41.7% of the women reported being examined more often than advised in national and international guidelines (every two to four hours). DISCUSSION: Although our study is limited, it shows that experiences with the VE during labor can be negative and should be considered carefully. We promote research of and teaching the use of additional noninvasive methods to assess progression of labor in daily clinical practice. We conclude that the number of VE's during labor should be restricted as much as possible. VE's should only be performed in the interest of the woman in labor, after her informed consent and preferably performed by as few different caregivers as possible.

Does measurement of intrauterine pressure have predictive value during oxytocin-augmented labor?

OBJECTIVE: In a previous randomized trial that compared monitoring uterine contractions with an intrauterine pressure catheter (IUPC) versus external monitoring, we demonstrated that use of an IUPC did not improve the outcome of labor. To provide insight in the lack of a positive effect, we evaluated level of IUP in Montevideo units (MU) in correlation with dysfunctional labor and adverse neonatal outcome. STUDY DESIGN: Here, we present two secondary analyses on the 503 women who had IUP measured in the trial. Firstly, we assessed labor outcome in relation to the highest IUP measured at any time during labor. Secondly, we assessed labor outcome to the IUP registered at the last vaginal examination during the first stage of labor in two study groups (above and below 200 MU). RESULTS: Women with lower IUP were statistically significant older, had pregnancies with a longer gestational age, longer labors and neonates with a higher birth weight. The risk of a cesarean section was higher in women who had low IUP during labor (Likelihood Ratio 1.6 for IUP < 100 MU, 0.41 for IUP > 300 MU). IUP was not associated with neonatal outcome. CONCLUSION: IUP is associated with mode of delivery. However, use of internal tocodynamometry does not improve birth outcomes.

Does use of an intrauterine catheter during labor increase risk of infection?

OBJECTIVE: To determine whether the use of an intrauterine catheter during labor is related to the occurrence of infection in mother or newborn during labor and up to 3 weeks postpartum. METHODS: We performed a follow-up study of 1435 women who participated in a previously published multicentre randomized controlled trial in the Netherlands that assigned women in whom labor was induced or augmented with intravenous oxytocin to internal or external tocodynamometry. In the present post hoc analysis, we assessed the risk for infection, defined as a composite measure of any clinical sign of infection, treatment with antibiotics or sepsis during labor or in the postpartum period up to 3 weeks in mother or newborn. RESULTS: There were 64 cases with indication of infection in the intrauterine catheter group (8.8%) versus 74 cases in the external monitoring group (10.4%). Relative risk: 0.91, 95% confidence interval: 0.77-1.1, and p: 0.33. CONCLUSION: Use of an intrauterine catheter during labor does not increase the risk of infection.