Drugs In Early Pregnancy Research Articles

Use of non‐steroidal anti‐inflammatory drugs in early pregnancy and preterm birth: is the jury still out?

When an analgesic or antipyretic is needed in pregnancy, nonsteroidal anti-inflammatory drugs (NSAIDs) are contraindicated at 20 weeks' gestation (WG) or later1 . Nevertheless, NSAIDs are thought to be used commonly prior to 20WG, though exact utilization is difficult to quantify because of over-the-counter use. With continued use and lack of early pregnancy guidance, the findings of this large, French study conducted by Quantin et al.2 are noteworthy, but conclusions should not be overstated.

Hyperthyroidism in pregnancy: evidence and hypothesis in fetal programming and development.

The management of hyperthyroidism in pregnant patients has been a topic of raised clinical awareness for decades. It is a strong recommendation that overt hyperthyroidism of Graves’ disease in pregnant women should be treated to prevent complications. The consequences of hyperthyroidism in pregnancy are less studied than hypothyroidism, and a literature review illustrates that the main burden of evidence to support current clinical guidance emerges from early observations of severe complications in Graves’ disease patients suffering from untreated hyperthyroidism in the pregnancy. On the other hand, the more long-term consequences in children born to mothers with hyperthyroidism are less clear. A hypothesis of fetal programming by maternal hyperthyroidism implies that excessive levels of maternal thyroid hormones impair fetal growth and development. Evidence from experimental studies provides clues on such mechanisms and report adverse developmental abnormalities in the fetal brain and other organs. Only few human studies addressed developmental outcomes in children born to mothers with hyperthyroidism and did not consistently support an association. In contrast, large observational human studies performed within the last decade substantiate a risk of teratogenic side effects to the use of antithyroid drugs in early pregnancy. Thus, scientific and clinical practice are challenged by the distinct role of the various exposures associated with Graves’ disease including the hyperthyroidism per se, the treatment, and thyroid autoimmunity. More basic and clinical studies are needed to extend knowledge on the effects of each exposure, on the potential interaction between exposures and with other determinants, and on the underlying mechanisms.

Extended spectrum penicillins reduce the risk of omphalocele: A population-based case-control study

BackgroundOmphalocele is a major congenital anomaly associated with significant morbidity and mortality. Regardless, the influence of maternal use of prescription drugs on the risk of omphalocele has only been addressed in a handful of studies. The aim of this study was to assess the influence of maternal risk factors and prescription drugs in early pregnancy on the risk of omphalocele. MethodsWe performed a nationwide register-based case-control study in Finland. The analysis is based on the Finnish Register of Congenital Malformations and Drugs and Pregnancy databases, both upheld by the Finnish Institute for Health and Welfare. All omphalocele cases were identified between Jan 1, 2004, and Dec 31, 2014. Five age-matched controls from the same geographical region were randomly selected for each case. The main outcome measures were maternal risk factors for omphalocele. Our analysis compared the maternal characteristics and the use of prescription drugs during the first trimester of pregnancy between case and control mothers. ResultsMothers of 359 omphalocele cases were compared with 1738 randomly selected age and area-matched mothers of healthy infants between 1 January 2014 and 31 December 2014. Both maternal obesity (BMI ≥30) and diabetes increased the risk for omphalocele, and their co-occurrence accumulated this risk (aOR 5.06, 95% Cl 1.19–21.4). Similarly, history of multiple miscarriages was an independent risk factor (2.51, 1.16–5.43). The oral use of extended spectrum penicillins during the first trimester of pregnancy had a significant, protective influence (0.17, 0.04–0.71). These analyses were adjusted for sex, parity, and risk factors reported above. No significant changes in risk were observed with any other medication used during the first trimester. ConclusionIn conclusion, these findings may suggest that extended spectrum penicillins in the first trimester reduces the risk of omphalocle formation. Additionally, consistent with earlier studies, previous repeated miscarriages, maternal obesity, and diabetes were significant risk factors for omphalocele.

MiR-183 impeded embryo implantation by regulating Hbegf and Lamc1 in mouse uterus

Embryo implantation plays a decisive role in pregnancy. While in the process of implantation, microRNA (miRNA) is an important regulatory factor in the post transcriptional level. However, the role of many miRNAs in embryo implantation remained unknown. In this study, microRNA-183 (miR-183) was found differentially expressed in mouse uterus during implantation. In vivo treatment of miR-183 agomir in the uterine horn before implantation could eliminate the number of implantation site. The localization of miR-183 in mouse uteri gradually changed from epithelial to stromal layer in early pregnancy. Mice implantation models demonstrated that the decrease of miR-183 was mainly caused by maternal factors. Loss and gain function of miR-183 in endometrial cell lines showed that miR-183 could inhibit cell migration, invasion and apoptosis. MiR-183 could inhibit embryo implantation by binding Heparin-Binding EGF-like growth factor (Hbegf) and Laminin gamma one (Lamc1), which were key genes in embryo apposition and penetration. All these evidences indicate that miR-183 plays an important role during embryo implantation. This study provides new insights into the functions of miR-183 during embryo implantation and the development of contraceptive drugs in early pregnancy.

Maternal Thyroid Function, Use of Antithyroid Drugs in Early Pregnancy, and Birth Defects.

Antithyroid drug (ATD) therapy in early pregnancy is associated with birth defects, but more data are needed to substantiate the risk associated with different types of ATD. Furthermore, the role of abnormal maternal thyroid function per se remains unclarified. To evaluate the risk of birth defects associated with the use of ATD in an extended nationwide cohort and the role of abnormal maternal thyroid function in birth cohorts including stored maternal blood samples from early pregnancy. Danish pregnant women and their live-born children, including 1,243,353 children from a Nationwide Register-Based Cohort (NRBC), 1997 to 2016; 8830 children from the Danish National Birth Cohort (DNBC), 1997 to 2003; and 14,483 children from the North Denmark Region Pregnancy Cohort (NDRPC), 2011 to 2015. Birth defects diagnosed before 2 years of age. In the NRBC, altogether 2718 (0.2%) children had been exposed to ATD in early pregnancy. The overall frequency of birth defects was 6.7% (95% CI, 6.7% to 6.8%) in nonexposed children and higher after exposure to methimazole/carbimazole (9.6%; 95% CI, 8.2% to 11.2%) and propylthiouracil (8.3%; 95% CI, 6.7% to 10.3%). On the other hand, the frequency of maternal thyroid dysfunction in early pregnancy was similar in the random cohort and in cases of birth defect in the DNBC (12.4 vs 12.6%, P = 0.8) and the NDRPC (15.1 vs 15.4%, P = 0.8). Results corroborate an increased risk of birth defects associated with the use of ATD in early pregnancy and suggest that abnormal maternal thyroid function is not a major risk factor for birth defects.

Birth defects after use of antithyroid drugs in early pregnancy: a Swedish nationwide study.

Antithyroid drugs (ATDs) may have teratogenic effects, but more evidence is needed on the risk and types of birth defects after the use of methimazole (MMI) and propylthiouracil (PTU). This study aimed to evaluate the association between the use of ATDs in early pregnancy and birth defects. Swedish nationwide register-based cohort study. The study included 684 340 children live-born in Sweden from 2006 to 2012. Exposure groups defined by maternal ATD use in early pregnancy were MMI (n = 162); PTU (n = 218); MMI and PTU (n = 66); ATD before or after, but not in pregnancy (n = 1551) and non-exposed (never ATD (n = 682 343)). Outcome was cumulative incidence of birth defects diagnosed before two years of age. The cumulative incidence of birth defects was not significantly different in children exposed to MMI (6.8%, P = 0.6) or PTU (6.4%, P = 0.4) vs non-exposed (8.0%). For subtypes of birth defects, MMI was associated with an increased incidence of septal heart defects (P = 0.02). PTU was associated with ear (P = 0.005) and obstructive urinary system malformations (P = 0.006). A case of choanal atresia was observed after exposure to both MMI and PTU. The incidence of birth defects in children born to mothers who received ATD before or after, but not in pregnancy, was 8.8% and not significantly different from non-exposed (P = 0.3), MMI exposed (P = 0.4) or PTU exposed (P = 0.2). MMI and PTU were associated with subtypes of birth defects previously reported, but the frequency of ATD exposure in early pregnancy was low and severe malformations described in the MMI embryopathy were rarely observed.

Maternal use of 5-aminosalicylates in early pregnancy and congenital malformation risk in the offspring

Objective. Most previous studies have failed to demonstrate any effect of maternal use of 5-aminosalicylates (5-ASA) on malformation risk, but the number of infants studied have, in most cases, been low. The objective of the study was to get data from a large study with prospectively ascertained exposure information. Material and methods. The study was based on data in the Swedish Medical Birth Register (1996–2011) where identification of maternal drug use is made from midwife interviews in early pregnancy. The presence of congenital malformations was ascertained from three national registers. Adjusted odds ratios were calculated by the Mantel-Haenszel methodology. Results. Among 1,552,109 women, 3651 with 3721 infants had reported the use of 5-ASAs in early pregnancy. The risk of a major malformation was increased (1.37, 95% confidence interval = 1.17–1.62) and still more for a cardiovascular defect (1.74, 1.37–2.22). This effect seemed to be influenced by concomitant use of systemic glucocorticosteroids or immunosuppressants but some confounding by indication may also exist. There was no marked difference between the four 5-ASA drugs studied. Conclusions. Infants born of women who use 5-ASA drugs in early pregnancy have an increased risk of a congenital malformation, notably a cardiovascular defect. This could be a drug effect or an effect of an active inflammatory bowel disease.

Maternal Asthma and Use of Antiasthmatic Drugs in Early Pregnancy and Congenital Malformations in the Offspring

Objectives: To investigate the risk of congenital malformations in infants born of women who had used antiasthmatic drugs in early pregnancy. Methods: Data were obtained from the Swedish Medical Birth Register for 1996-2011. Information on drug use was based on midwife interviews towards the end of the first trimester. Presence of congenital malformations was ascertained from three national health registers. Risk estimates were made with Mantel-Haenszel odds ratios after adjustment for delivery year, maternal age, parity, smoking, and body mass index. Consideration was taken to concomitantly used drugs. Results: Among more than 1.5 million women who gave birth, 2.9% reported the use of antiasthmatics. These women had characteristics which distinguished them from other women who gave birth and they more often than these used other drugs than antiasthmatics. These differences seemed to affect malformation risk only little. The risk for a major malformation was slightly but significantly increased (odds ratio=1.09, 95% confidence interval 1.03-1.12), specifically this was seen for cardiovascular defects, median cleft palate, and pyloric stenosis. There was no specific association with specific drugs or drug groups, the highest risk estimate was seen for women who used only one drug and notably a short-acting adrenergic or used three or more antiasthmatic drug groups. Conclusion: The absolute risk for a congenital malformation in infants born of women using antiasthmatics is low and some evidence indicates that it is due to underlying asthma. A good control of asthma seems important and scare of teratogenicity of the common antiasthmatic drugs should not prevent adequate use.

Antiobesity drugs in early pregnancy and congenital malformations in the offspring

Little information exists on the possible teratogenic effect of modern antiobesity drugs. The present study refers to orlistat, sibutramine, and rimonabant. Data in the Swedish Medical Birth Register were utilised. During the years 1998-2011, among 392,126 infants born, 509 had been exposed to antiobesity drugs in early pregnancy: 248 to orlistat, 242 to sibutramine, 12 to rimonabant, 13 to unspecified antiobesity drugs. Simultaneous use of orlistat and sibutramine occurred in six cases. No increase in major malformation risk was seen after orlistat (relative risk=0.42, 95% confidence interval 0.11-1.07) but a significantly high risk was seen after sibutramine (relative risk=1.81, 95% confidence interval 1.02-2.99). The latter effect, which seemed to be mainly due to an increased risk for a cardiovascular defects, may be related to the capacity of the drug to prolong QT-time. Sibutramine has been withdrawn in Europe but is still available on the Internet and is a component in some slimming preparations. Among the 12 infants exposed to rimonabant, two which were in a twin pair were malformed.

Periconceptional folic acid and teratogenic drug use in women undergoing fertility treatments

Objective: To evaluate periconception drug use in women undergoing fertility treatment and compare it to women with spontaneous pregnancies. Methods: Retrospective observational cohort study on reproductive-age women. Data on pregnancies, fertility treatments, prescription fillings and demographics were extracted from Clalit Health Services computerized systems. Two quality measures were evaluated: periconception folic acid prescription fillings and use of potentially hazardous drugs in early pregnancy. Results: There were 12,891 fertility treatment cycles in 4868 women; and 4968 women had spontaneous pregnancy. Periconceptional folic acid use was low and similar in both groups (31.3% of fertility cycles versus 29.9% of spontaneous pregnancies, p = 0.07). In the infertility group, 293 prescriptions for potentially hazardous drugs were filled within 45 days after the beginning of a fertility cycle (2.3% of cycles) compared to only 47 (0.9%) in women with spontaneous pregnancy (p < 0.001). Conclusions: The periconception medical care of women who undergo fertility treatment is suboptimal and is not better than in women with spontaneous pregnancies. Folic acid use that can reduce the risk of congenital anomalies is underused; whereas the use of potentially hazardous drugs in early pregnancy is significant. More intensive and targeted counseling regarding drug use before pregnancy is urgently needed.

Are angiotensin-converting enzyme inhibitors and angiotensin receptor blockers safe in pregnancy: a report of ninety-one pregnancies

Both angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin receptor antagonists (ARBs) have been reported to be associated with an excess of congenital abnormalities in infants born to women who took these drugs in pregnancy. To investigate this possible association further, we have examined the outcome in 91 pregnancies in which the mother took either an ACE-I (n = 71) or an ARB (n = 20) in early pregnancy. We also examined the United Kingdom adverse drug reaction reporting system to assess the total number of reported associations of ACE-I or ARB use in pregnancy and congenital anomalies reported. Eight (8.8%) of the pregnancies led to an infant with a developmental anomaly, but all save one of these (craniosynostosis with tower skull) anomalies were considered to be relatively minor. The adverse drug reaction reporting system revealed a total of 43 reported defects in women taking an ACE-I and 12 in women taking an ARB. We have not found any convincing excess of congenital anomalies in women taking angiotensin-blocking drugs in early pregnancy. However, this does not exclude the possibility that ACE-I or ARB use in pregnancy might lead to adverse obstetrical outcomes. Until this matter is settled, we support recommendations that these drugs should not be used in pregnancy or in women who are likely to become pregnant.

Suspected Spontaneous Reports of Birth Defects in the UK Associated with the Use of Carbimazole and Propylthiouracil in Pregnancy

The concept of a carbimazole embryopathy underlies current Endocrine Society advice to avoid this drug in early pregnancy, favouring propylthiouracil as an alternative for the treatment of maternal hyperthyroidism. We aimed to establish whether suspected spontaneous reporting of adverse drug reactions in the UK via the Yellow Card Scheme supports a carbimazole embryopathy and the lack of association between propylthiouracil and congenital anomalies. All birth defects related to maternal treatment with carbimazole or propylthiouracil reported over a 47-year period via the Yellow Card Scheme were analysed. 57 cases with 97 anomalies were reported following in utero exposure to carbimazole. These anomalies included aplasia cutis, choanal atresia, tracheo-oesophageal fistula, and patent vitellointestinal duct, which have previously been reported in association with carbimazole/methimazole exposure in utero. Only 6 cases with 11 anomalies were reported for propylthiouracil, all within the last 15 years. Therefore, these findings may support a carbimazole embryopathy. There are few birth defects associated with propylthiouracil, but this should be interpreted in the context of higher historical prescription rates for carbimazole.

Menstrual regulation by (15S)-15 methyl prostaglandin F2 alpha by intramuscular route.

(15S)-15 Methyl Prostaglandin F2 Alpha (Carboprost trometha-mine) was used as an abortificient drug in early pregnancy not exceeding 49 days. Its efficacy, side effects and complications were studied and discussed.

Is the exposure to antidepressant drugs in early pregnancy a risk factor for spontaneous abortion? A review of available evidences

To review studies conducted to establish the risk of spontaneous abortion (SA) in women exposed to antidepressant drugs (ADs) during early pregnancy. By using different search terms, PubMed, Toxline, EMBASE, PsychINFO, and the Cochrane library databases were searched from January 1980 to March 2008, to identify studies assessing the risk of SA in women exposed to different classes of ADs during the first trimester of pregnancy. Ten studies over 21 identified were selected for the analysis. All were performed prospectively and included as control group unexposed women, or exposed to non-teratogenic drugs or to placebo. In seven studies a depressive episode was specified as the reason for which the drug was prescribed, while the time of exposure was in nine. Only three studies over ten selected reported a significant association between an increased rate of SAs and early pregnancy exposure to some ADs. Many methodological flaws in the study design were found in all studies considered. Given this background and a lack of strong evidence on this issue, further prospective and better designed studies are needed to assess the risk of SA in pregnant women exposed to ADs against the risk of an untreated maternal depression.

Maternal use of antihypertensive drugs in early pregnancy and delivery outcome, notably the presence of congenital heart defects in the infants

To investigate the association between maternal use of antihypertensives in early pregnancy and delivery outcome, notably infant congenital malformations. A cohort study of 1,418 women who had used antihypertensive drugs in early pregnancy but had no diabetes diagnosis were identified from the Swedish Medical Birth Register. There was an excess risk for placental abruption, caesarean section, delivery induction, and post-delivery hemorrhage in women taking hypertensives. Infants were more often than expected born preterm, were small for gestational age, and had an excess of various neonatal symptoms. Cardiovascular defects occurred with an adjusted odds ratio of 2.59 (95% CI 1.92-3.51). The results were similar when the woman had used ACE inhibitors or other antihypertensives, notably beta blockers. Stillbirth rate was increased (risk ratio 1.87, 95% CI 1.02-3.02), again without any clear drug specificity. There seems to be little drug specificity in the association between maternal use of antihypertensives and an increased risk for infant cardiovascular defects.

Hyperemesis Gravidarum That Requires Hospitalization and the Use of Antiemetic Drugs in Relation to Maternal Body Composition

Objective The purpose of this study was to assess whether maternal prepregnancy body mass index was associated with the use of antiemetic drugs in early pregnancy and/or with the occurrence of hyperemesis gravidarum. Study Design A retrospective, population-based, cohort study. Women who delivered singleton infants (n = 749,435) from 1995-2003 were evaluated concerning the use of antiemetic drugs in early pregnancy (data available from 1995). Women who delivered singleton infants (n = 942,894) from 1992-2001 were evaluated concerning hospitalization because of hyperemesis gravidarum (data available until 2001). Adjusted odds ratios were determined by Mantel-Haenszel technique and were used as estimates of relative risk (RR). Results Underweight pregnant women were more likely to use antiemetic drugs (RR, 1.19; 95% CI, 1.14-1.24) and to become hospitalized for hyperemesis gravidarum (RR, 1.43; 95% CI, 1.33-1.54) compared with ideal weight women. Obese women were less likely to use antiemetic drugs (RR, 0.93; 95% CI, 0.89-0.97) and less likely to require hospitalization because of hyperemesis (RR, 0.90; 95% CI, 0.85-0.95) compared with women with an ideal body mass index. Conclusion The use of antiemetic drugs and the occurrence of hyperemesis gravidarum are related to maternal body composition.

Recreational Drug Use: A Major Risk Factor for Gastroschisis?

The authors tested the hypothesis that the birth prevalence of gastroschisis is positively associated with use of recreational drugs in early pregnancy. A matched case-control study was carried out in three regions of the United Kingdom over the period January 2001 through August 2003. For each case, three liveborn controls were matched by initial intended place of delivery, region, and maternal age. Maternal hair analysis provided independent verification of recreational drug use. Conditional logistic regression was used to estimate mutually adjusted odds ratios. Estimates were revised using data from hair analysis. Statistically significant adjusted odds ratios for gastroschisis were associated with first-trimester use of 1) any recreational drug (odds ratio (OR) = 2.2, 95% confidence interval (CI): 1.2, 4.3) and 2) vasoconstrictive recreational drugs (defined as cocaine, amphetamines, and ecstasy) (OR = 3.3, 95% CI: 1.0, 10.5). Other significant exposures included aspirin use (OR = 20.4, 95% CI: 2.2, 191.5), cigarette smoking (OR = 1.7, 95% CI: 1.1, 2.6), and prior history of gynecologic infection/disease (OR = 2.6, 95% CI: 1.2, 5.6). Recreational drug use is a significant risk factor for gastroschisis and is one of a constellation of potentially preventable exposures which include cigarette smoking, aspirin use, and history of gynecologic infection/disease. Maternal hair analysis proved an acceptable and valuable method of independently verifying recreational drug use.

Timing of intermittent preventive treatment for malaria during pregnancy and the implications of current policy on early uptake in north-east Tanzania

BackgroundIntermittent preventive treatment (IPTp) is efficacious in reducing the adverse outcomes associated with pregnancy-associated malaria, however uptake of the recommended two doses is low in Tanzania, and little is known of the timepoint during pregnancy at which it is delivered. This study investigated the timing of delivery of IPTp to pregnant women attending antenatal clinics (ANC), and the potential determinants of timely uptake.MethodsStructured interviews were conducted with staff and pregnant women at antenatal clinics in northeast Tanzania, and antenatal consultations were observed. Facility-based and individual factors were analysed for any correlation with timing of IPTp uptake.ResultsAlmost half the women interviewed first attended ANC during or before the fourth month of gestation, however 86% of these early attendees did not receive IPTp on their first visit. The timing of IPTp delivery complied closely with the national guidelines which stipulate giving the first dose at 20–24 weeks gestation. Uptake of at least one dose of IPTp among women who had reached this gestation age was 67%, although this varied considerably between clinics. At one facility, IPTp was not delivered because SP was out of stock.ConclusionEarly uptake of IPTp was found to be hampered by factors external to health worker performance or women's individual preferences. These include insufficient drug stocks and an apparent lack of information to health workers on the reasoning for continued use of SP for IPTp when it has been replaced as a first-line treatment. In addition, an unexpectedly high proportion of women attend antenatal clinics before 20 weeks of pregnancy. While current policy denies the use of IPTp at this time, there is emerging, but incomplete, evidence that malaria in early pregnancy may contribute considerably to the burden of pregnancy-related malaria. Current policy may thus result in a missed opportunity for maximising the benefit of this intervention, and efforts to encourage earlier attendance at ANC alone are unlikely to improve uptake of IPTp. More evidence is needed to weigh the benefits of early IPTp use against theoretical risks of antifolate drugs in early pregnancy.

Hyperemesis gravidarum that requires hospitalization and the use of antiemetic drugs in relation to maternal body composition

The purpose of this study was to assess whether maternal prepregnancy body mass index was associated with the use of antiemetic drugs in early pregnancy and/or with the occurrence of hyperemesis gravidarum. A retrospective, population-based, cohort study. Women who delivered singleton infants (n = 749,435) from 1995-2003 were evaluated concerning the use of antiemetic drugs in early pregnancy (data available from 1995). Women who delivered singleton infants (n = 942,894) from 1992-2001 were evaluated concerning hospitalization because of hyperemesis gravidarum (data available until 2001). Adjusted odds ratios were determined by Mantel-Haenszel technique and were used as estimates of relative risk (RR). Underweight pregnant women were more likely to use antiemetic drugs (RR, 1.19; 95% CI, 1.14-1.24) and to become hospitalized for hyperemesis gravidarum (RR, 1.43; 95% CI, 1.33-1.54) compared with ideal weight women. Obese women were less likely to use antiemetic drugs (RR, 0.93; 95% CI, 0.89-0.97) and less likely to require hospitalization because of hyperemesis (RR, 0.90; 95% CI, 0.85-0.95) compared with women with an ideal body mass index. The use of antiemetic drugs and the occurrence of hyperemesis gravidarum are related to maternal body composition.

Recreational Drug Use: A Major Risk Factor for Gastroschisis?

The authors tested the hypothesis that the birth prevalence of gastroschisis is positively associated with use of recreational drugs in early pregnancy. A matched case-control study was carried out in three regions of the United Kingdom over the period January 2001 through August 2003. For each case, three liveborn controls were matched by initial intended place of delivery, region, and maternal age. Maternal hair analysis provided independent verification of recreational drug use. Conditional logistic regression was used to estimate mutually adjusted odds ratios. Estimates were revised using data from hair analysis. Statistically significant adjusted odds ratios for gastroschisis were associated with first-trimester use of 1) any recreational drug (odds ratio (OR) = 2.2, 95% confidence interval (CI): 1.2, 4.3) and 2) vasoconstrictive recreational drugs (defined as cocaine, amphetamines, and ecstasy) (OR = 3.3, 95% CI: 1.0, 10.5). Other significant exposures included aspirin use (OR = 20.4, 95% CI: 2.2, 191.5), cigarette smoking (OR = 1.7, 95% CI: 1.1, 2.6), and prior history of gynecologic infection/disease (OR = 2.6, 95% CI: 1.2, 5.6). Recreational drug use is a significant risk factor for gastroschisis and is one of a constellation of potentially preventable exposures which include cigarette smoking, aspirin use, and history of gynecologic infection/disease. Maternal hair analysis proved an acceptable and valuable method of independently verifying recreational drug use.