Immediate delivery versus expectant monitoring for hypertensive disorders of pregnancy between 34 and 37 weeks of gestation (HYPITAT-II): an open-label, randomised controlled trial.

BACKGROUND: There is little evidence to guide the management of women with hypertensive disorders in late preterm pregnancy. We investigated the effect of immediate delivery versus expectant monitoring on maternal and neonatal outcomes in such women. METHODS: We did an open-label, randomised controlled trial, in seven academic hospitals and 44 non-academic hospitals in the Netherlands. Women with non-severe hypertensive disorders of pregnancy between 34 and 37 weeks of gestation were randomly allocated to either induction of labour or caesarean section within 24 h (immediate delivery) or a strategy aimed at prolonging pregnancy until 37 weeks of gestation (expectant monitoring). The primary outcomes were a composite of adverse maternal outcomes (thromboembolic disease, pulmonary oedema, eclampsia, HELLP syndrome, placental abruption, or maternal death), and neonatal respiratory distress syndrome, both analysed by intention-to-treat. This study is registered with the Netherlands Trial Register (NTR1792). FINDINGS: Between March 1, 2009, and Feb 21, 2013, 897 women were invited to participate, of whom 703 were enrolled and randomly assigned to immediate delivery (n=352) or expectant monitoring (n=351). The composite adverse maternal outcome occurred in four (1·1%) of 352 women allocated to immediate delivery versus 11 (3·1%) of 351 women allocated to expectant monitoring (relative risk [RR] 0·36, 95% CI 0·12-1·11; p=0·069). Respiratory distress syndrome was diagnosed in 20 (5·7%) of 352 neonates in the immediate delivery group versus six (1·7%) of 351 neonates in the expectant monitoring group (RR 3·3, 95% CI 1·4-8·2; p=0·005). No maternal or perinatal deaths occurred. INTERPRETATION: For women with non-severe hypertensive disorders at 34-37 weeks of gestation, immediate delivery might reduce the already small risk of adverse maternal outcomes. However, it significantly increases the risk of neonatal respiratory distress syndrome, therefore, routine immediate delivery does not seem justified and a strategy of expectant monitoring until the clinical situation deteriorates can be considered. FUNDING: ZonMw.

Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia between 34 and 37 weeks' gestation (HYPITAT-II): a multicentre, open-label randomised controlled trial.

BACKGROUND: Gestational hypertension (GH) and pre-eclampsia (PE) can result in severe complications such as eclampsia, placental abruption, syndrome of Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP) and ultimately even neonatal or maternal death. We recently showed that in women with GH or mild PE at term induction of labour reduces both high risk situations for mothers as well as the caesarean section rate. In view of this knowledge, one can raise the question whether women with severe hypertension, pre-eclampsia or deterioration chronic hypertension between 34 and 37 weeks of gestation should be delivered or monitored expectantly. Induction of labour might prevent maternal complications. However, induction of labour in late pre-term pregnancy might increase neonatal morbidity and mortality compared with delivery at term. METHODS/DESIGN: Pregnant women with severe gestational hypertension, mild pre-eclampsia or deteriorating chronic hypertension at a gestational age between 34+0 and 36+6 weeks will be asked to participate in a multi-centre randomised controlled trial. Women will be randomised to either induction of labour or expectant monitoring. In the expectant monitoring arm, women will be induced only when the maternal or fetal condition detoriates or at 37+0 weeks of gestation. The primary outcome measure is a composite endpoint of maternal mortality, severe maternal complications (eclampsia, HELLP syndrome, pulmonary oedema and thromboembolic disease) and progression to severe pre-eclampsia. Secondary outcomes measures are respiratory distress syndrome (RDS), neonatal morbidity and mortality, caesarean section and vaginal instrumental delivery rates, maternal quality of life and costs. Analysis will be intention to treat. The power calculation is based on an expectant reduction of the maternal composite endpoint from 5% to 1% for an expected increase in neonatal RDS from 1% at 37 weeks to 10% at 34 weeks. This implies that 680 women have to be randomised. DISCUSSION: This trial will provide insight as to whether in women with hypertensive disorders late pre-term, induction of labour is an effective treatment to prevent severe maternal complications without compromising the neonatal morbidity. TRIAL REGISTRATION: NTR1792 CLINICAL TRIAL REGISTRATION: http://www.trialregister.nl.

Use of insulin like growth factor binding protein-1 in the diagnosis of ruptured fetal membranes.

OBJECTIVE: The benefit of insulin like growth factor binding protein-1 (IGFBP-1) in diagnosing ruptured fetal membranes in cases in which the diagnosis is clinically doubtful, is investigated. DESIGN: A total of 83 patients with clinically doubtful rupture of fetal membranes were included, and treated as usual. The clinical diagnosis, the amniotic fluid crystallization test, and IGFBP-1 detection were performed on all patients and compared with the defined gold standard. The sensitivity, specificity, positive predictive value, and negative predictive value of each test were calculated. RESULTS: In all, 27 patients (33%) had ruptured fetal membranes at the time of inclusion. The clinical diagnosis of the attending obstetrician showed a higher predictive value of both a positive and negative test result than both IGFBP-1 detection, and the amniotic fluid crystallization test. CONCLUSIONS: As the clinical diagnosis showed the highest sensitivity and specificity, IGFBP-1 detection has no additional benefit to ascertain the diagnosis of ruptured fetal membranes in cases in which the diagnosis was clinically doubtful.

[Recurrent miscarriage turns out to be lung cancer]. / Herhaalde miskraam blijkt longkanker.

BACKGROUND: If a positive pregnancy test is followed by profuse vaginal bleeding, the diagnosis of miscarriage can generally be made. Sometimes, however, elevated hCG levels may be associated with a phantom pregnancy, which may be a paraneoplastic symptom. CASE DESCRIPTION: A 27-year-old woman was referred for a diagnosis after having experienced 3 consecutive miscarriages. The diagnostic workup could not identify an underlying cause. After 3 more biochemical miscarriages, the original diagnosis was called into question and extensive testing for ectopic hCG production was performed. It appeared that the false pregnancies were paraneoplastic symptoms of an hCG-producing non-small cell lung cancer. After a lobectomy, the hCG levels returned to normal and a spontaneous pregnancy and uncomplicated delivery followed. CONCLUSION: Phantom pregnancy as a paraneoplastic symptom is extremely rare, but should be considered in patients presenting with recurrent, non-objectifiable miscarriages. Careful documentation of the menstrual cycle is necessary for early detection of the condition. The fact is that vaginal bleeding after a positive pregnancy test can still be a normal menstruation.

[Congenital toxoplasmosis: severe ocular and neurological complications]. / Congenitale toxoplasmose: ernstige oculaire en neurologische complicaties.

Two infants with congenital toxoplasmosis are presented. A girl born prematurely was treated postnatally after the mother had received antimicrobial treatment during pregnancy for acute toxoplasmosis. Apart from being small for gestational age, she remained without symptoms and treatment was ceased after 13 months. A 2-month-old boy presented with hydrocephalus and chorioretinitis, consistent with congenital toxoplasmosis. Despite antimicrobial treatment, at 12 months of age he suffered from epilepsy, cerebral palsy and vision impairment. Most infants with congenital toxoplasmosis (2 per 1000 live births in the Netherlands) are asymptomatic at birth. The education of pregnant women is crucial for the prevention of congenital toxoplasmosis. Awareness of antenatal and postnatal presenting signs and symptoms is important for clinicians, because early diagnosis and treatment may minimize sequelae. Untreated, the majority of affected infants will develop chorioretinitis, deafness and/or neurological symptoms.