[Show abstract][Hide abstract] ABSTRACT: Background:
Thyroid peroxidase antibodies (TPO-Ab) in euthyroid women are associated with recurrent miscarriage (RM) and other pregnancy complications such as preterm birth. It is unclear if treatment with levothyroxine improves pregnancy outcome. Aim To determine the effect of levothyroxine administration on live birth rate in euthyroid TPO-Ab positive women with recurrent miscarriage.
/Design We will perform a multicenter, placebo controlled randomized trial in euthyroid women with recurrent miscarriage and TPO-Ab. Recurrent miscarriage is defined as two or more miscarriages before the 20th week of gestation. The primary outcome is live birth, defined as the birth of a living fetus beyond 24weeks of gestation. Secondary outcomes are ongoing pregnancy at 12weeks, miscarriage, preterm birth, (serious) adverse events, time to pregnancy and survival at 28days of neonatal life. The analysis will be performed according to the intention to treat principle. We need to randomize 240 women (120 per group) to demonstrate an improvement in live birth rate from 55% in the placebo group to 75% in the levothyroxine treatment group. This trial is a registered trial (NTR 3364, March 2012). Here we discuss the rationale and design of the T4-LIFE study, an international multi-center randomized, double blind placebo controlled, clinical trial aimed to assess the effectiveness of levothyroxine in women with recurrent miscarriage and TPO-Ab.
[Show abstract][Hide abstract] ABSTRACT: Objectives:
To validate the Labor and Delivery Index (LADY-X), a new delivery-specific utility measure.
Study design and setting:
In a test-retest design, women were surveyed online, 6 to 8 weeks postpartum and again 1 to 2 weeks later. For reliability testing, we assessed the standard error of measurement (S.E.M.) and the intraclass correlation coefficient (ICC). For construct validity, we tested hypotheses on the association with comparison instruments (Mackey Childbirth Satisfaction Rating Scale and Wijma Delivery Experience Questionnaire), both on domain and total score levels. We assessed known-group differences using eight obstetrical indicators: method and place of birth, induction, transfer, control over pain medication, complications concerning mother and child, and experienced control.
The questionnaire was completed by 308 women, 257 (83%) completed the retest. The distribution of LADY-X scores was skewed. The reliability was good, as the ICC exceeded 0.80 and the S.E.M. was 0.76. Requirements for good construct validity were fulfilled: all hypotheses for convergent and divergent validity were confirmed, and six of eight hypotheses for known-group differences were confirmed as all differences were statistically significant (P-values: <0.001-0.023), but for two tests, difference scores did not exceed the S.E.M.
The LADY-X demonstrates good reliability and construct validity. Despite its skewed distribution, the LADY-X can discriminate between groups. With the preference weights available, the LADY-X might fulfill the need for a utility measure for cost-effectiveness studies for perinatal care interventions.
Journal of clinical epidemiology 07/2015; DOI:10.1016/j.jclinepi.2015.05.020 · 3.42 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Preeclampsia is a pregnancy-specific syndrome characterized by renal dysfunction and high blood pressure. When evaluated with light microscopy, the renal lesion of preeclampsia is marked by endothelial cell swelling and the appearance of bloodless glomeruli. However, regarding the pathobiology of renal damage in preeclampsia, attention recently has shifted from the glomerular endothelial cells to the podocytes. The angiogenic imbalance in preeclampsia plays a key role in the development of both podocyte and endothelial damage in the glomerular filtration barrier. Here, we review the latest studies on the role of podocytes in the development of renal damage in preeclampsia and on podocytes as potential targets for diagnosis, treatment, and prevention of long-term complications of preeclampsia.
Current Hypertension Reports 07/2015; 17(7):566. DOI:10.1007/s11906-015-0566-9 · 3.44 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To assess the effect of maintenance tocolysis in women who are at high or low risk for preterm delivery according to fetal fibronectin (fFN) status and cervical length (CL).
We compared the risk of preterm delivery in fFN pos and fFN neg women and in women with a CL <15 mm and ≥15 mm, by using the Cox regression. Differences between the effectiveness of maintenance tocolysis in high- and low-risk women were assessed by using an interaction term.
122 fFN tests were taken, of which 50 were fFN pos. CL was measured in 236 women, of whom 52 women had a CL <15 mm. The median gestational age at delivery was lower in fFN pos women; fFN pos women had a higher hazard for preterm delivery at any point of time (HR 4.7; 95% CI 2.9 to 7.6). Comparable results were seen for CL. Neither fFN status nor CL did alter the effect of maintenance tocolysis, which was ineffective in the total randomized group, on the risk of preterm delivery (p for interaction = 0.87 for fFN and 0.18 for CL).
Maintenance tocolytic therapy with nifedipine is ineffective and not dependent on fFN or CL status.
The journal of maternal-fetal & neonatal medicine: the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians 06/2015; DOI:10.3109/14767058.2015.1053863 · 1.37 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Results from a number of long-term follow-up studies have suggested that hypertensive disorders in pregnancy are associated with increased risk of cardiovascular disease later in life. More recently, this putative relationship has been substantiated with findings of elevated cardiovascular risk factors, such as lipid profiles and glucose, in women with a history of hypertensive pregnancy disorders. Homocysteine is a sensitive indicator of increased risk but data on homocysteine levels in women with a history of hypertensive pregnancy disorders are inconsistent.
This cohort study included 279 women with a history of hypertensive pregnancy disorders at term and 85 women with a history of uncomplicated pregnancies who participated in the Hypitat Risk Assessment Study (HyRAS).
Blood samples for total homocysteine determination were taken 2.5 years postpartum. Homocysteine levels were determined in plasma using an immunoassay.
Women with a history of hypertensive pregnancy disorders had significant higher median homocysteine levels (10.66 μmol/L) 2.5 years postpartum compared with women with a history uncomplicated pregnancies (9.82 μmol/L; p=0.002). Women with a history of hypertensive pregnancy disorders had a higher risk of having a homocysteine level in the highest quartile (odds ratio 3.4, 95% confidence interval 1.5-7.6).
At 2.5 years postpartum, women with a history hypertensive pregnancy disorders had higher homocysteine levels than women who had uncomplicated pregnancies. Although higher homocysteine levels might be a potential link between a history of hypertensive pregnancy disorders and increased cardiovascular disease risk later in life, the clinical implications remain an area for future research.
Journal of Women's Health 06/2015; 24(6):524-529. DOI:10.1089/jwh.2015.5201 · 2.05 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objective Cervical length (CL) is associated with the risk of preterm birth (PTB) in multiple pregnancies. However, the position of CL within the pathophysiological pathway of PTB is unclear, and it is unknown which factors are predictive for CL. This study aims to investigate whether in twin pregnancies baseline maternal and obstetrical characteristics are potential indicators for CL, to improve insight in the pathophysiological pathway of PTB. Study Design Secondary analysis of data on twin pregnancies and CL measurement between 16 and 22 weeks. A set of 10 potential indicators, known to be associated with an increased risk of PTB and/or which have a plausible mechanism resulting in a change of CL were selected. We used multivariable linear regression with backward selection to identify independent indicators for CL. Results A total of 1,447 women with twin pregnancies were included. Mean CL was 43.7 (± 8.9) mm. In multivariable analysis, age (0.27 mm/y; 95% confidence interval [CI] 0.16 to 0.39), use of assisted reproductive technologies (ART) (-1.42 mm, 95% CI -2.6 to -0.25), and having delivered at term in a previous pregnancy (1.32 mm, 95% CI 0.25 to 2.39) were significantly associated with CL. Conclusion This study shows that in twin pregnancies, age, use of ART and having delivered term in a previous pregnancy has an association with CL.
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American Journal of Perinatology 04/2015; DOI:10.1055/s-0035-1549396 · 1.91 Impact Factor