Publications by authors named "Robert Mittendorf"

24 Publications

  • Page 1 of 1

Association between topiramate and zonisamide use during pregnancy and low birth weight.

Obstet Gynecol 2014 Jan;123(1):21-28

Department of Epidemiology, Harvard School of Public Health, and North American Antiepileptic Drug Pregnancy Registry, Massachusetts General Hospital for Children, Boston, Massachusetts; Loyola University Health System, Chicago, Illinois; the College of Physicians and Surgeons and Mailman School of Public Health, Columbia University, New York, New York; and Oregon Health and Science University, Portland, Oregon.

Objective: To assess the possible effects of topiramate and zonisamide use during pregnancy on fetal growth.

Methods: The study population was the singleton liveborns born to women who enrolled in the North American Antiepileptic Drug Pregnancy Registry between 1997 and 2012. Data were collected through telephone interviews at enrollment, 7 months of gestation, and postpartum. The prevalence of small for gestational age at birth among neonates exposed to topiramate and to zonisamide when either was used as monotherapy during pregnancy was compared with that among neonates exposed to lamotrigine monotherapy, a weight-neutral therapy, and the most common antiepileptic drug in the Registry. Relative risks (RRs) and 95% confidence intervals (CIs) were estimated with multivariable log-binomial regression to control for potential confounders.

Results: Data were available for 347 topiramate, 98 zonisamide, and 1,581 lamotrigine-exposed neonates. The mean gestational length was 39 weeks for all comparison groups. Prenatal exposure to topiramate or zonisamide was associated with a mean lower birth weight of 221 and 202 g, respectively, and a mean lesser neonatal length of 1 cm as compared with lamotrigine exposure (p<.01). The prevalence of small for gestational age was 6.8% for lamotrigine, 17.9% for topiramate (RR 2.4, 95% CI 1.8-3.3) and 12.2% for zonisamide (RR 1.6, 0.9-2.8). Similar results were found when a group of 457 unexposed neonates was used as the reference.

Conclusions: Topiramate and zonisamide have been shown to reduce weight in adults. Our finding of a decrease in mean birth weight and length among neonates exposed in utero raises concern.

Level Of Evidence: II.
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http://dx.doi.org/10.1097/AOG.0000000000000018DOI Listing
January 2014

Fetal effects of anticonvulsant polytherapies: different risks from different drug combinations.

Arch Neurol 2011 Oct 13;68(10):1275-81. Epub 2011 Jun 13.

North American AED Pregnancy Registry, Genetics Unit, MassGeneral Hospital for Children, Boston, MA 02114, USA.

Objective: To determine the frequency of malformations among infants born to women who had taken lamotrigine or carbamazepine as part of polytherapy during the first trimester of pregnancy.

Design: A cohort of women enrolled during pregnancy in the North American AED (Antiepileptic Drug) Pregnancy Registry between February 1, 1997, and June 1, 2010. Information on AED use and demographic characteristics was collected in 3 telephone interviews.

Setting: United States and Canada.

Patients: A total of 6857 pregnant women taking an AED for any reason.

Main Outcome Measures: Major congenital malformations were identified at birth and through the first 12 weeks after delivery. Diagnoses were based on the mother's report and confirmed by medical records. The risks of malformations were compared between polytherapy and monotherapy groups, using exact odds ratios (ORs) and 95% confidence intervals (CIs).

Results: The risk of malformations was 1.9% among infants exposed to lamotrigine as monotherapy (n = 1441). Among the infants exposed to lamotrigine as polytherapy (n = 505), the risks were 9.1% for lamotrigine plus valproate sodium (OR, 5.0; 95% CI, 1.5-14.0) and 2.9% for lamotrigine plus any other AEDs (1.5; 0.7-3.0). The risk of malformations was 2.9% for the infants exposed to carbamazepine monotherapy (n = 1012). For the infants exposed to carbamazepine as polytherapy (n = 365), the risks were 15.4% for carbamazepine plus valproate (OR, 6.2; 95% CI, 2.0-16.5) and 2.5% for carbamazepine plus any other AEDs (0.8; 0.3-1.9). Confounding by factors such as periconceptional vitamin use, cigarette smoking, alcohol use, and chronic maternal diseases did not explain the results.

Conclusions: The risk of malformations among infants exposed to lamotrigine and carbamazepine as polytherapy was higher than the corresponding monotherapies only when the polytherapy includes valproate. These findings suggest that counseling for fetal risks from AED polytherapy should be based on the specific drugs included.
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http://dx.doi.org/10.1001/archneurol.2011.133DOI Listing
October 2011

Using prophylactic, but not tocolytic, magnesium sulfate to reduce cerebral palsy related to prematurity: what dose, and what about infant mortality?

J Perinat Med 2011 07 14;39(4):375-8. Epub 2011 Apr 14.

University of Wisconsin Medical School, Madison, WI, USA.

Strategies for the prevention of cerebral palsy (CP) remain incompletely characterized. Recognizing that half of all cases are associated with preterm delivery (Australian CP Register Report, 2009), research protocols aimed at reducing its prevalence have focused on interventions in pregnancies at risk for preterm birth. Compelling data from recent clinical trials have led to an emerging consensus favoring the use of antenatal magnesium sulfate for preterm neuroprophylaxis. Unresolved, however, is the critical question regarding the "best dose". Acknowledging that any substance in high enough doses becomes toxic, the "best dose" is really the least dose that achieves efficacy, while minimizing potential toxicity among susceptible fetuses. Importantly, credible evidence from these CP prevention trials indicates that antenatal magnesium sulfate, if dosed appropriately, may also decrease infant mortality--a worthy goal in its own right. Accordingly, whether we achieve (a) reduction in CP only, (b) simultaneous reduction in CP and infant mortality, or (c) CP reduction offset by possibly increased pediatric mortality, may depend on selection of dose. In this Opinion paper, we review the findings of all major randomized trials that tested the magnesium hypothesis for prevention of CP. In addition, we discuss future research, in progress, that is hoped to refine estimates of best dose.
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http://dx.doi.org/10.1515/jpm.2011.036DOI Listing
July 2011

Contemporary usage of obstetric magnesium sulfate: indication, contraindication, and relevance of dose.

Obstet Gynecol 2009 Sep;114(3):669-673

From The University of Wisconsin Medical School, Madison, Wisconsin; and the Departments of Obstetrics and Gynecology and of Pediatrics, Loyola University Medical Center, Maywood, Illinois.

Magnesium sulfate, a biologically potent compound, given sometimes in extraordinarily high doses, is among the most commonly used pharmaceuticals in American obstetric practice. Although most clinicians are in accord regarding its value for seizure prophylaxis in the setting of preeclampsia, such unanimity is not the case regarding its role in preterm labor. Credible scientific data indicate not only a lack of efficacy, but also toxicity to susceptible fetuses when magnesium sulfate is used in the high dosages found in tocolysis. In apparent contrast, three recent clinical trials, although individually inconclusive, provide data from which a very recent meta-analysis affirms a potential role for magnesium sulfate in prophylaxis against fetal neurologic injury. Comparing outcomes from these trials, with attention to dosage, relationships are revealed that unify observations previously regarded as conflicting: Magnesium sulfate indeed may have both neuroprotective and fetal toxic effects. The better, and safer, neuroprotection seems to occur at comparatively low antenatal doses (perhaps in a range between 4 g and 10.5 g), whereas increasing dosages exceed a "therapeutic window" whereby, as with most drugs, toxic sequelae begin to accrue.
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http://dx.doi.org/10.1097/AOG.0b013e3181b43b0eDOI Listing
September 2009

Magnesium sulfate for the prevention of cerebral palsy.

N Engl J Med 2009 Jan;360(2):189-90; author reply 190

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http://dx.doi.org/10.1056/NEJMc081995DOI Listing
January 2009

Relationships between umbilical cord arterial blood pH levels at delivery and Bayley Psychomotor Development Index scores in early childhood.

J Perinat Med 2008 ;36(4):335-40

Department of Obstetrics and Gynecology, Loyola University Medical Center, Maywood, IL 60153, USA.

Aims: To correlate data on umbilical cord arterial blood pH (pHa) levels obtained at delivery with subsequent Bayley Psychomotor Development (PDI) scores determined on the same cohort of children at age 18 months.

Methods: At delivery, we obtained umbilical cord bloods for pHa levels along with other biological parameters. Following the birth cohort prospectively, at age 18 months we did a comprehensive, blinded neurodevelopmental examination to determine a PDI score for each child.

Results: Over the broad range of umbilical cord arterial blood pH levels from 7.03 to 7.52, no statistically significant correlation (Pearson correlation coefficient, -0.016, P=0.88) was found between pHa at delivery and PDI scores at age 18 months. To study our finding in greater detail, we formed a subset of the data consisting only of lower pHa levels at delivery (defined as
Conclusions: Our findings are consistent with the evolving hypothesis that adverse neurological outcomes in children often have etiologies other than intrapartum fetal acidemia.
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http://dx.doi.org/10.1515/JPM.2008.043DOI Listing
September 2008

Magnesium sulfate tocolysis: time to quit.

Obstet Gynecol 2007 May;109(5):1204-5

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http://dx.doi.org/10.1097/01.AOG.0000263775.75185.1eDOI Listing
May 2007

Neuroprophylaxis with aminophylline and magnesium sulfate?

Am J Obstet Gynecol 2006 Feb;194(2):593; author reply 594

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http://dx.doi.org/10.1016/j.ajog.2005.07.007DOI Listing
February 2006

Special relationships between fetal inflammatory response syndrome and bronchopulmonary dysplasia in neonates.

J Perinat Med 2005 ;33(5):428-34

Department of Obstetrics and Gynecology, Loyola University Medical Center, Maywood, IL 60153, USA.

Objective: To confirm previous known relationships between Fetal Inflammatory Response Syndrome (FIRS) and neonatal bronchopulmonary dysplasia (BPD) and to present information on previously unknown special relationships between inflammatory variables and BPD.

Study Design: At delivery, we obtained biological specimens including umbilical cord venous blood for plasma interleukin-6 levels, as well as placental histology and bacteriology. Among other neonatal outcomes, we collected prospective information on BPD.

Results: Of 141 newborns in the study, 16 had BPD; 79% of these had antecedent FIRS, 27% of those without FIRS had BPD. By multivariable regression, only very low birth weight (adjusted [adj] odds ratio [OR] 32.0, 95% Confidence Interval [CI] 5.0 to positive infinity) and FIRS (adj OR 5.7, 95% CI 1.1 to 42.3) remained significant risk factors. Escherichia coli, perhaps due to its pyogenic nature (strongly elicits inflammatory responses), may have had a special relationship with BPD.

Conclusions: In our data, FIRS and neonatal BPD are highly associated. It is possible that certain pyogenic bacteria in the chorioamnion space may be implicated more often than others.

Condensation: Neonates having Fetal Inflammatory Response Syndrome at delivery may later develop BPD. Pyogenic bacteria, such as Escherichia coli, may be implicated more frequently.
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http://dx.doi.org/10.1515/JPM.2005.076DOI Listing
December 2005

A review of the role for magnesium sulphate in preterm labour.

BJOG 2005 Mar;112 Suppl 1:84-8

Department of Obstetrics and Gynaecology, Loyola University Medical Center, 2160 South First Avenue, Maywood, IL 60153, USA.

During the last decade, the body of medical knowledge concerning the use of pharmacological doses of magnesium sulphate (MgSO(4)) for preterm labour has increased substantially. Several randomised controlled trials (RCTs) have provided compelling evidence that MgSO(4) is the drug of choice for maternal seizure prophylaxis in pre-eclampsia, whether preterm or term. In contrast, a recent Cochrane systematic review of the relevant contemporary literature has found no evidence basis to support the use of MgSO(4) for tocolysis in preterm labour. Furthermore, associated with high-dosage tocolytic MgSO(4), recent data indicate a possible increased risk for neonatal intraventricular haemorrhage (IVH), as well as increased total paediatric mortality. It is possible, on the other hand, that the prophylactic administration of much lower dosages of MgSO(4), in selected cases of preterm labour, may have a neuroprotective effect for a small number of infants.
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http://dx.doi.org/10.1111/j.1471-0528.2005.00592.xDOI Listing
March 2005

Risk-benefit effects of tocolytic therapy.

Expert Opin Drug Saf 2004 Nov;3(6):639-54

University of Wisconsin Medical School, Madison, USA.

Tocolytics are potent drugs that are used to interdict preterm labour. Although all of these agents have some side effects, if not frankly adverse effects under certain clinical situations, two of these drugs, the beta-mimetics and magnesium sulphate (MgSO(4)), have been found to have considerable potential for adverse maternal cardiovascular and respiratory effects. Furthermore, magnesium sulphate has been shown to have harmful, indeed, sometimes lethal, effects in some babies. Although less well established, NSAIDs, the most common example of which is indomethacin, also have some important adverse effects in fetuses. Within the limits of contemporary scientific knowledge, calcium channel blockers, such as nifedipine, appear to be among the more efficacious and safer drugs that are currently being used for tocolysis.
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http://dx.doi.org/10.1517/14740338.3.6.639DOI Listing
November 2004

Antenatal risk factors associated with the development of lenticulostriate vasculopathy (LSV) in neonates.

J Perinatol 2005 Feb;25(2):101-7

Department of Obstetrics and Gynecology (R.M., J.G.G.), Loyola University Medical Center, Maywood, IL 60153, USA.

Objective: To determine the antenatal risk factors associated with neonatal lenticulostriate vasculopathy (LSV).

Study Design: Women in preterm labor were randomized to magnesium sulfate (MgSO4), other tocolytic, or saline control. The surviving babies underwent head ultrasounds (HUS) (weeks of life 1, 2, and 4) and periodic developmental examinations (months 4, 8, 12, and 18).

Results: Of 140 infants, 17.1% (24) had neonatal intraventricular hemorrhage (IVH), and 10.0% (14) had LSV (half of the latter (7 of 14) had both IVH and LSV). In a regression model in which other risk factors were controlled for, the association between antenatal exposures to tocolytic MgSO4 >or=50 g and LSV were significant (adjusted odds ratio (OR), 8.3; 95% confidence interval (CI), 1.5 to 45.0; p=0.01).

Conclusion: Based on our data and their analyses, we infer that antenatal exposure to high-dosage, tocolytic MgSO4 may be associated with LSV.
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http://dx.doi.org/10.1038/sj.jp.7211212DOI Listing
February 2005

Association between lenticulostriate vasculopathy (LSV) and neonatal intraventricular hemorrhage (IVH).

J Perinatol 2004 Nov;24(11):700-5

Department of Obstetrics and Gynecology, Loyola University Medical Center, Maywood, IL 60153, USA.

Objectives: To determine whether there is an unconfounded association between neonatal intraventricular hemorrhage (IVH) and lenticulostriate vasculopathy (LSV (also known as thalamostriate or mineralizing vasculopathy)).

Study Design: During the conduct of the Magnesium and Neurologic Endpoints Trial (MagNET), a randomized controlled trial involving maternal, hence fetal, exposure to antenatal magnesium sulfate in the context of preterm labor, head ultrasounds were obtained for each of the surviving neonates. Because of our previous experience in the diagnosis of LSV, when ascertaining the presence of IVH, as called for by the research protocol of our study, the presence or absence of LSV was also determined.

Results: We found LSV to be relatively prevalent (10% (14 of 140) among surviving babies). More importantly, it was significantly associated with the occurrence of neonatal IVH, even when controlled for possible confounding (adjusted OR 9.8, 95% confidence interval 1.3 to 73.1; p=0.03).

Conclusion: Given the known relationships between IVH and neonatal morbidity and mortality, the finding of a statistically significant association between neonatal IVH and LSV may suggest more substantial implications for the latter than previously believed.
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http://dx.doi.org/10.1038/sj.jp.7211173DOI Listing
November 2004

Second overview of relationships between antenatal pharmacologic magnesium sulfate and neurologic outcomes in children.

J Perinat Med 2004 ;32(3):201-10

Department of Obstetrics and Gynecology, Loyola University Medical Center, Maywood, IL 60153, USA.

In the last ten years, the body of scientific knowledge concerning the use of antenatal pharmacologic magnesium sulfate (MgSO4) has become substantially larger. Several randomized controlled trials have provided compelling evidence that MgSO4 is the drug of choice for maternal seizure prophylaxis in toxemia. In contrast, the recent Cochrane Systematic Review, as well as other studies, have shown there is no evidence basis for the use of MgSO4 for tocolysis. Furthermore, when tocolytic-strength doses of MgSO4 are employed, there is an excess risk for total pediatric mortality (Cochrane Systematic Review and our own previous work). It is conceivable, nonetheless, that low doses of MgSO4, when used as prophylaxis in some selected cases of preterm labor, may ultimately be shown to be neuroprotective for a relatively small number of children. Unfortunately, the indiscriminate use of high-dosage MgSO4 for attempted tocolysis in preterm labor is much more likely to cause harm than do good.
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http://dx.doi.org/10.1515/JPM.2004.038DOI Listing
August 2004

Components of the systemic fetal inflammatory response syndrome as predictors of impaired neurologic outcomes in children.

Am J Obstet Gynecol 2003 Jun;188(6):1438-4; discussion 1444-6

Department of Obstetrics and Gynecology, Loyola University Medical Center, Maywood, IL 60153, USA.

Objective: The purpose of this study was to compare interleukin-6 and funisitis as predictors of impaired neurologic outcomes in children by performing a secondary analysis on data that were collected prospectively for another purpose.

Study Design: We examined umbilical cords for funisitis and obtained cord blood for interleukin-6 levels. A psychomotor developmental index score was determined for each child at age 18 months.

Results: The prevalence (46%) of elevated interleukin-6 levels (> or = 10 pg/mL) among children with low psychomotor developmental index scores (<100) was not significantly different from that of children with normal scores (47%). Among children with funisitis (n = 21), the median psychomotor developmental index score was 94; for children without funisitis (n = 92), it was 99 (P <.02). When the data were regressed for confounding, funisitis remained significant (adjusted odds ratio, 1.3; 95% CI, 1.1-1.9). Furthermore, funisitis was a more specific predictor of low psychomotor developmental index scores (P <.001), although elevated interleukin-6 levels were more sensitive.

Conclusion: When used for the prediction of impaired neurologic outcomes in children, funisitis has better specificity and thus a better positive predictive value than does interleukin-6.
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http://dx.doi.org/10.1067/mob.2003.380DOI Listing
June 2003

Relationship between hypermagnesaemia in preterm labour and adverse health outcomes in babies.

Magnes Res 2002 Dec;15(3-4):253-61

Department of Obstetrics and Gynecology, Loyola University Medical Center, Maywood, IL 60153, USA.

The Magnesium and Neurologic Endpoints Trial (the so-called MagNET Trial) was a randomized clinical trial that was undertaken to establish whether the antenatal usage of magnesium sulphate could protect neonates from having adverse neurologic outcomes. Unfortunately, the trial was suspended after 15 months of enrolment because of excess total paediatric mortality among those exposed to magnesium sulphate. Following our original report and contrary to the original hypotheses, additional analyses of our data have actually shown a statistically significant increase in the risk of neonatal intraventricular hemorrhage, as well as total adverse paediatric outcomes, among those with higher levels of ionized magnesium at delivery. Nonetheless, it has been postulated, but not established, that anions of magnesium other than sulphate could have a more benign, or even beneficial, effect on health outcomes in the neonate.
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December 2002

The magpie trial.

Lancet 2002 Oct;360(9342):1330-1; author reply 1331-2

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http://dx.doi.org/10.1016/S0140-6736(02)11323-7DOI Listing
October 2002

Association between maternal obesity and fetal cardiac malformations in African Americans.

J Natl Med Assoc 2002 Aug;94(8):695-700

Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, USA.

Objective: To find out whether an association exists between obesity in non-diabetic African-American women and congenital malformations in their babies.

Methods: Using a retrospective study design in a large cohort of African American women, we identified deliveries in which children had birth defects. Because of its known association with congenital malformations, mothers with clinical diabetes, as well as certain other potential confounders, were excluded. Body mass indices (BMI = kg/m2) of women who delivered babies with birth defects (cases) were compared with randomly selected women who delivered babies without malformations (controls). Obesity was defined as BMI > or = 27.

Results: Among more than 38,000 deliveries, we found 130 cases of babies with birth defects. Of these, 63 babies had major congenital malformations and 67 had minor malformations. For purposes of comparison, we randomly selected 144 babies without birth defects to be controls. As compared to non-obese, non-diabetic African American women, obese non-diabetic African American women were significantly more likely to have babies with a cardiac anomaly (OR 6.5; 95% CI 1.2, 34.9; P = 0.025). Other organ-specific, major birth defects were not significantly associated with maternal obesity.

Conclusions: In addition to urging reduction of excess weight prior to pregnancy, we need to ensure that all African American women with obesity have sophisticated mid-trimester ultrasound screening to look for major fetal cardiac malformations.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2594270PMC
August 2002

Association between the use of antenatal magnesium sulfate in preterm labor and adverse health outcomes in infants.

Am J Obstet Gynecol 2002 Jun;186(6):1111-8

Department of Obstetrics and Gynecology, Loyola University Medical Center, Maywood, IL 60153, USA.

Objective: The purpose of this study was to determine whether the use of antenatal magnesium sulfate prevents adverse outcomes (neonatal intraventricular hemorrhage, periventricular leucomalacia, death, and cerebral palsy).

Study Design: In a controlled trial, we randomized mothers in preterm labor to magnesium sulfate, "other" tocolytic, or placebo. At delivery, umbilical cord blood was collected for the later determination of serum ionized magnesium levels. Neonatal cranial ultrasound scans were obtained periodically for the diagnosis of intraventricular hemorrhage and periventricular leucomalacia. Among survivors, the diagnosis of cerebral palsy was made at age 18 months.

Results: Children with adverse outcomes had higher umbilical cord magnesium levels at delivery. In regression models that controlled for confounders, which included very low birth weight, magnesium remained a significant risk factor (adjusted odds ratio, 3.7; 95% CI, 1.1-11.9; P =.03).

Conclusion: Contrary to original hypotheses, this randomized trial found that the use of antenatal magnesium sulfate was associated with worse, not better, perinatal outcome in a dose-response fashion.
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http://dx.doi.org/10.1067/mob.2002.123544DOI Listing
June 2002

Association between maternal serum ionized magnesium levels at delivery and neonatal intraventricular hemorrhage.

J Pediatr 2002 May;140(5):540-6

Department of Obstetrics and Gynecology, Loyola University Medical Center, Maywood, Illinois 60153, USA.

Objectives: To determine whether magnesium sulfate (MgSO(4)) exposure is associated with a reduced risk for neonatal intraventricular hemorrhage (IVH).

Study Design: In a randomized, controlled trial, women in preterm labor were randomly assigned to receive MgSO(4), "other" tocolytic, or saline control. At delivery, we collected maternal antecubital and umbilical cord blood for determination of serum ionized magnesium levels. Neonatal IVH was diagnosed by cranial ultrasonogram.

Results: Among 144 infants, 24 were diagnosed with IVH. Using crude intention-to-treat analysis, we found that 18% (13/74) of survivors exposed after birth to MgSO(4) had IVH compared with 16% (11/70) of babies who were not exposed. Infants who had IVH were more likely to have been delivered by mothers with higher serum ionized magnesium (Mg) levels (0.75 vs 0.56 mmol/L) (P =.01). Using multivariable logistic regression, we confirmed that higher Mg levels are a significant predictor of neonatal IVH (adjusted odds ratio, 15.8; 95% CI, 1.4-175.0) even when adjusted for birth weight, gestational age, antenatal hemorrhage, and neonatal glucocorticoid exposure.

Conclusions: In mothers with preterm labor, our data indicate that antenatal MgSO(4) exposure may be associated with an increased risk for IVH among their newborns.
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http://dx.doi.org/10.1067/mpd.2002.123283DOI Listing
May 2002
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