The objective of this study was to assess the effects of CenteringPregnancy (CP) in the Netherlands on different health outcomes. A stepped wedged cluster randomized trial was used, including 2132... Show moreThe objective of this study was to assess the effects of CenteringPregnancy (CP) in the Netherlands on different health outcomes. A stepped wedged cluster randomized trial was used, including 2132 women of approximately 12 weeks of gestation, from thirteen primary care midwifery centres in and around Leiden, Netherlands. Data collection was done through self-administered questionnaires. Multilevel intention-to-treat analysis and propensity score matching for the entire group and separately for nulliparous- and multiparous women were employed. The main outcomes were: health behaviour, health literacy, psychological outcomes, health care use, and satisfaction with care. Women’s participation in CP is associated with lower alcohol consumption after birth (OR = 0.59, 95 %CI 0.42–0.84), greater consistency with norms for healthy eating and physical activity (β = 0.19, 95 %CI 0.02–0.37), and higher knowledge about pregnancy (β = 0.05, 95 %CI 0.01–0.08). Compared to the control group, nulliparous women who participating in CP reported better compliance to the norm for healthy eating and physical activity (β = 0.28, 95 %CI0.06–0.51)) and multiparous CP participants consumed less alcohol after giving birth (OR = 0.42, 95 %CI 0.23–0.78). Health care use and satisfaction rates were significantly higher among CP participants. A non-significant trend toward lower smoking rates was documented among CP participants. Overall, the results of this study reveal a positive (postpartum) impact on fostering healthy behaviours among participants. Show less
Bentem, K. van; Hoorn, M.L. van der; Lith, J. van; Cessie, S. le; Lashley, E. 2022
Introduction The assisted reproductive technique of oocyte donation (OD) is comparable to in vitro fertilisation (IVF), with the distinction of using a donated oocyte and thus involving two women.... Show moreIntroduction The assisted reproductive technique of oocyte donation (OD) is comparable to in vitro fertilisation (IVF), with the distinction of using a donated oocyte and thus involving two women. Compared with IVF and naturally conceived (NC) pregnancies, OD pregnancies have a higher risk for pregnancy complications as pregnancy-induced hypertension (PIH) and pre-eclampsia (PE). Various covariates among women pregnant by OD, however, also contribute to an increased risk for developing hypertensive complications. Therefore, we will conduct the DONation of Oocytes in Reproduction individual participant data (DONOR IPD) meta-analysis to determine the risk for the development of hypertensive complications in OD pregnancy, in comparison to autologous oocyte pregnancy (non-donor IVF/intracytoplasmic sperm injection (ICSI) and NC pregnancy). The DONOR IPD meta-analysis will provide an opportunity to adjust for confounders and perform subgroup analyses. Furthermore, IPD will be used to externally validate a prediction model for the development of PE in OD pregnancy. Methods and analysis A systematic literature search will be performed to search for studies that included women pregnant by OD, and documented on hypertensive complications in OD pregnancy. The authors from each study will be asked to collaborate and share IPD. Using the pseudoanonymised combined IPD, we will perform statistical analyses with one-stage and two-stage approaches, subgroup analyses and possibly time-to-event analyses to investigate the risk of developing hypertensive complications in OD pregnancy. Furthermore, we will formally assess a prediction model on its performance in an external validation with the use of IPD. Ethics and dissemination Ethical approval and individual patient consent will not be required in most cases since this IPD meta-analysis will use existing pseudoanonymised data from cohort studies. Results will be disseminated through peer-reviewed journals and international conferences. PROSPERO registration number CRD42021267908. Show less
Youssef, A.; Hoorn, M.L.P. van der; Dongen, M.; Visser, J.; Bloemenkamp, K.; Lith, J. van; ... ; Lashley, E.E.L.O. 2021
Study question: What is the predictive performance of a currently recommended prediction model in an external Dutch cohort of couples with unexplained recurrent pregnancy loss (RPL)?Summary answer: .. Show moreStudy question: What is the predictive performance of a currently recommended prediction model in an external Dutch cohort of couples with unexplained recurrent pregnancy loss (RPL)?Summary answer: The model shows poor predictive performance on a new population; it overestimates, predicts too extremely and has a poor discriminative ability.What is known already: In 50-75% of couples with RPL, no risk factor or cause can be determined and RPL remains unexplained. Clinical management in RPL is primarily focused on providing supportive care, in which counselling on prognosis is a main pillar. A frequently used prediction model for unexplained RPL, developed by Brigham et al. in 1999, estimates the chance of a successful pregnancy based on number of previous pregnancy losses and maternal age. This prediction model has never been externally validated.Study design, size, duration: This retrospective cohort study consisted of 739 couples with unexplained RPL who visited the RPL clinic of the Leiden University Medical Centre between 2004 and 2019.Participants/materials, setting, methods: Unexplained RPL was defined as the loss of two or more pregnancies before 24 weeks, without the presence of an identifiable cause for the pregnancy losses, according to the ESHRE guideline. Obstetrical history and maternal age were noted at intake at the RPL clinic. The outcome of the first pregnancy after intake was documented. The performance of Brigham's model was evaluated through calibration and discrimination, in which the predicted pregnancy rates were compared to the observed pregnancy rates.Main results and the role of chance: The cohort included 739 women with a mean age of 33.1 years (±4.7 years) and with a median of three pregnancy losses at intake (range 2-10). The mean predicted pregnancy success rate was 9.8 percentage points higher in the Brigham model than the observed pregnancy success rate in the dataset (73.9% vs 64.0% (95% CI for the 9.8% difference 6.3-13.3%)). Calibration showed overestimation of the model and too extreme predictions, with a negative calibration intercept of -0.46 (95% CI -0.62 to -0.31) and a calibration slope of 0.42 (95% CI 0.11-0.73). The discriminative ability of the model was very low with a concordance statistic of 0.55 (95% CI 0.51-0.59). Recalibration of the Brigham model hardly improved the c-statistic (0.57; 95% CI 0.53-0.62).Limitations, reasons for caution: This is a retrospective study in which only the first pregnancy after intake was registered. There was no time frame as inclusion criterium, which is of importance in the counselling of couples with unexplained RPL. Only cases with a known pregnancy outcome were included.Wider implications of the findings: This is the first study externally validating the Brigham prognostic model that estimates the chance of a successful pregnancy in couples with unexplained RPL. The results show that the frequently used model overestimates the chances of a successful pregnancy, that predictions are too extreme on both the high and low ends and that they are not much more discriminative than random luck. There is a need for revising the prediction model to estimate the chance of a successful pregnancy in couples with unexplained RPL more accurately.Study funding/competing interest(s): No external funding was used and no competing interests were declared.Trial registration number: N/A.Keywords: external validation; miscarriage; prediction model; pregnancy success rate; recurrent pregnancy loss. Show less
Petrus, A.H.J.; Jongert, B.L.; Kies, P.; Sueters, M.; Jongbloed, M.R.M.; Vliegen, H.W.; ... ; Akker, T. van den 2020
Objective: Maternal heart disease (HD) complicates 1-4 % of pregnancies and is associated with adverse maternal and fetal outcomes. Although vaginal birth is generally recommended in the guidelines... Show moreObjective: Maternal heart disease (HD) complicates 1-4 % of pregnancies and is associated with adverse maternal and fetal outcomes. Although vaginal birth is generally recommended in the guidelines, cesarean section (CS) rates in women with HD are often high. Aim of the present study was to evaluate mode of birth and pregnancy outcomes in women with HD in a tertiary care hospital in the Netherlands.Study design: The study population consisted of 128 consecutive pregnancies in 99 women with HD, managed by a pregnancy heart team between 2012-2017 and ending in births after 24 weeks' gestation. Pregnancy risk was assessed per modified World Health Organization class. Mode of birth (planned and performed) and maternal and fetal complications (cardiovascular events, postpartum hemorrhage, prematurity, small for gestational age and death) were assessed for each pregnancy.Results: Pregnancy risk was classified as modified World Health Organization class I in 23 %, class II in 50 %, class III in 21 % and class IV in 6% of pregnancies. Planned mode of birth was vaginal in 114 pregnancies (89 %) and CS in 14 (11 %; nine for obstetric and five for cardiac indication). An unplanned CS was performed in 18 pregnancies (16 %; 16 for obstetric and two for cardiac indications). Overall mode of birth was vaginal in 75 % and CS in 25 %. Twelve cardiovascular events occurred in eight pregnancies (6 %), postpartum hemorrhage in nine (7 %) and small for gestational age in 14 (11 %). No maternal or fetal deaths occurred.Conclusions: Findings of this study indicate that - given that pregnancies are managed and mode of birth is meticulously planned by a multidisciplinary pregnancy heart team - vaginal birth is a suitable option for women with HD. (C) 2020 Elsevier B.V. All rights reserved. Show less
Freeman, L.; Middeldorp, J.; Akker, E. van den; Oudijk, M.; Bax, C.; Huizen, M. van; ... ; Akker-van Marle, E. van den 2018
