Behavioural and neurodevelopmental outcome of 2-year-old children after preterm premature rupture of membranes: follow-up of a randomised clinical trial comparing induction of labour and expectant management

Heyden, Jantien L. van der; Willekes, Christine; Baar, Anneloes L. van; Wassenaer-Leemhuis, Aleid G. van; Pajkrt, Eva; Oudijk, Martijn A.; Porath, Martina; Duvekot, Hans; Bloemenkamp, Kitty W. M.; Groenewout, Mariette; Woiski, Mallory; Bijvank, Bas Nij; Bax, Caroline J.; Hooft, Janneke van ’t; Sikkema, Marko; Akerboom, Bettina M.C.; Mulder, Twan A; Nijhuis, Jan G.; Mol, Ben Willem J.; Ham, David P. van der

doi:10.1016/j.ejogrb.2015.07.014

Cited by 17 publications

(11 citation statements)

References 18 publications

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“…Our cohort still showed a higher risk of abnormal development (21.3%) compared to the standard Dutch population, in which an abnormal score is expected for 2.3%) [17]. This strengthens previous studies that both hypertensive disorders and preterm birth are associated with increased risk of abnormal development [23][24][25][26][27][28][29]. For behavioral outcomes the gap between the reference and the study population was less pronounced: by definition 17% of the reference population had a score above the borderline cut-off, compared to 16.1% in the 2-year follow-up [17].…”

Section: Results In the Context Of What Is Knownsupporting

confidence: 88%

Neonatal developmental and behavioral outcomes of immediate delivery versus expectant monitoring in mild hypertensive disorders of pregnancy: 5-year outcomes of the HYPITAT II trial

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Broekhuijsen

et al. 2020

European Journal of Obstetrics & Gynecology and Reproductiv

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Section: Results In the Context Of What Is Knownsupporting

confidence: 88%

Neonatal developmental and behavioral outcomes of immediate delivery versus expectant monitoring in mild hypertensive disorders of pregnancy: 5-year outcomes of the HYPITAT II trial

Zwertbroek

Broekhuijsen

et al. 2020

European Journal of Obstetrics & Gynecology and Reproductiv

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“…On the other hand, the expectant management was related to a higher risk of hemorrhage, intrapartum fever, use of postpartum antibiotics, and longer hospital stay [6]. In addition, expectant management might be associated with worsening of neurodevelopmental outcomes in children aged 2 years, as shown in the PROMEXIL study [10]. Taken together, a personalized management of PPROM between 34 and 37 weeks based on the knowledge of the intra-amniotic environment might be a possible solution for this clinical dilemma.…”

Section: Introductionmentioning

confidence: 94%

Preterm Prelabor Rupture of Membranes between 34 and 37 Weeks: A Point-of-Care Test of Vaginal Fluid Interleukin-6 Concentrations for a Noninvasive Detection of Intra-Amniotic Inflammation

et al. 2017

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Objective: The aim of this study was to investigate whether a previously reported vaginal fluid point-of-care interleukin (IL)-6 cut-off value of 2,500 pg/mL can be used for the identification intra-amniotic inflammation in women with preterm prelabor rupture of membranes (PPROM) between 34 and 37 weeks. Material and Methods: A prospective cohort study was conducted in women with singleton gestation complicated by PPROM between 34 + 0 and 36 + 6 weeks.Vaginal fluid was successfully obtained in 118 women from the posterior vaginal fornix via aspiration using a sterile urine sample tube with a suction tip. Amniotic fluid was obtained via transabdominal amniocentesis. IL-6 concentrations were assessed in both fluids immediately after sampling. Intra-amniotic inflammation was defined as an amniotic fluid point-of-care IL-6 concentration of ≥745 pg/mL. Results: The tested vaginal fluid IL-6 cut-off value had a sensitivity of 91%, specificity of 91%, positive predictive value of 50%, negative predictive value of 99%, positive likelihood ratio of 9.7, and negative likelihood ratio of 0.1 for the identification of intra-amniotic inflammation. Conclusion: The point-of-care vaginal fluid IL-6 test with a cut-off value of 2,500 pg/mL shows good sensitivity, specificity, and negative predictive value for the identification of intra-amniotic inflammation in PPROM between 34 and 37 weeks.

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“…In 2015, our research team performed a follow-up study of children at 2 years of age, born to women who participated in the PPROMEXIL trial. 9 This follow-up study was performed with limited budget and used internationally validated screening questionnaires. Even though this study had a follow-up rate of 44% and no extensive neurodevelopmental assessments were used, an increase in neurodevelopmental impairment was found in the expectant management group as compared with the induction of labour group (abnormal score (−2 SD) in ≥1 domains of the Ages and Stages Questionnaire: 14% induction of labour group vs 26% expectant management group, difference in percentage −11.4; 95% CI −21.9 to −0.98).…”

Section: Introductionmentioning

confidence: 99%

Child outcomes after induction of labour or expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks of gestation: study protocol of the PPROMEXIL Follow-up trial. A long-term follow-up study of the randomised controlled trials PPROMEXIL and PPROMEXIL-2

et al. 2021

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IntroductionLate preterm prelabour rupture of membranes (PROM between 34+0 and 36+6 weeks gestational age) is an important clinical dilemma. Previously, two large Dutch randomised controlled trials (RCTs) compared induction of labour (IoL) to expectant management (EM). Both trials showed that early delivery does not reduce the risk of neonatal sepsis as compared with EM, although prematurity-related risks might increase. An extensive, structured long-term follow-up of these children has never been performed.Methods and analysisThe PPROMEXIL Follow-up trial (NL6623 (NTR6953)) aims to assess long-term childhood outcomes of the PPROMEXIL (ISRCTN29313500) and PPROMEXIL-2 trial (ISRCTN05689407), two multicentre RCTs using the same protocol, conducted between 2007 and 2010 evaluating IoL versus EM in women with late preterm PROM. The PPROMEXIL Follow-up will analyse children of mothers with a singleton pregnancy (PPROMEXIL trial n=520, PPROMEXIL-2 trial n=191, total IoL n=359; total EM n=352). At 10–12 years of age all surviving children will be invited for a neurodevelopmental assessment using the Wechsler Intelligence Scale for Children-V, Color-Word Interference Test and the Movement Assessment Battery for Children-2. Parents will be asked to fill out questionnaires assessing behaviour, motor function, sensory processing, respiratory problems, general health and need for healthcare services. Teachers will fill out the Teacher Report Form and answer questions regarding school attainment. For all tests means with SDs will be compared, as well as predefined cut-off scores for abnormal outcome. Sensitivity analyses consisting of different imputation techniques will be used to deal with lost to follow-up.Ethics and disseminationThe study has been granted approval by the Medical Centre Amsterdam (MEC) of the AmsterdamUMC (MEC2016_217). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results.Trial registration numberNL6623 (NTR6953).

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Behavioural and neurodevelopmental outcome of 2-year-old children after preterm premature rupture of membranes: follow-up of a randomised clinical trial comparing induction of labour and expectant management

Cited by 17 publications

References 18 publications

Neonatal developmental and behavioral outcomes of immediate delivery versus expectant monitoring in mild hypertensive disorders of pregnancy: 5-year outcomes of the HYPITAT II trial

Neonatal developmental and behavioral outcomes of immediate delivery versus expectant monitoring in mild hypertensive disorders of pregnancy: 5-year outcomes of the HYPITAT II trial

Preterm Prelabor Rupture of Membranes between 34 and 37 Weeks: A Point-of-Care Test of Vaginal Fluid Interleukin-6 Concentrations for a Noninvasive Detection of Intra-Amniotic Inflammation

Child outcomes after induction of labour or expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks of gestation: study protocol of the PPROMEXIL Follow-up trial. A long-term follow-up study of the randomised controlled trials PPROMEXIL and PPROMEXIL-2

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