| Study | Country Study period Study design |
Data source | Exposure definition | Non-exposure definition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
|---|---|---|---|---|---|---|---|---|
|
Bateman - Calcium blockers 2015 |
USA 2000 - 2007 retrospective cohort (claims database) |
The Medicaid Analytic eXtract (MAX), an administrative dataset that contains information on Medicaid enrollment and utilization claims. | Maternal consumption of a calcium channel blocker during the final 30 days of pregnancy (exposure that occurred between 33 and 40 weeks gestation). |
unexposed (general population or NOS)
Parturients without a calcium channel blocker dispensing whose days supply overlaps the final 30 days of pregnancy. |
late pregnancy | 22908 / 2506728 | The most commonly used calcium channel blocker was nifedipine (n = 21449), other calcium channel blockers used included amlodipine besylate (n = 523), verapamil hydrochloride (n = 424), and diltiazem hydrochloride (n = 339). | |
| Exposure was defined based on filled prescriptions. | ||||||||
|
Bayliss - Calcium blockers 2002 |
United Kingdom (UK) 1980 - 1999 retrospective cohort |
The antenatal hypertension clinics in two district general hospitals (Birmingham and Sutton Coldfield), United Kingdom. | Pregnancies in patient who had been taking calcium channel blockers from either conception or during the first trimester of pregnancy (i.e., before 15 weeks) until delivery. |
unexposed, sick
Pregnancies in women with hypertension who took no anti-hypertensive medication at all throughout their pregnancy. |
throughout pregnancy | 40 / 189 | Patients who suffered a miscarriage or intra-uterine death were excluded from the analysis. Also patients who started their pregnancies on one drug and later had a second added were excluded from the main analysis. | |
| Clinical data are collected on drug treatment used before and during pregnancy. Data is collected prospectively from the clinics (patient’s hospital records) onto a proforma and entered into a computer database by a research associate (MB). | ||||||||
|
Bortolus - Nifedipine 2000 |
Italy 1992 - 1994 randomized controlled trial |
A randomised multicentre clinical trial, in 33 obstetric and nephrology centres, Gruppo di Studio Ipertensione in Gravidanza, Italy. | Children born to women with hypertension randomly assigned to slow-release nifedipine, starting from 10 mg twice daily (increased up to 80 mg daily, if necessary). |
unexposed, sick
Children born to women with hypertension randomly assigned to no treatment. |
2nd and/or 3rd trimester | 130 / 130 | Methods completed with the 1st publication of this clinical trial: Parazziniet al., 1998. For all malformations: overlapping between Parazzini et al., 1998 and Bortolus 2000 => use of the 1st one because it is based on a higher number of babies. | |
| Eligible women were randomly assigned treatment group. Group allocation was done by telephone to the Istituto Mario Negri in Bergamo. The randomisation list was generated by computer. Separate randomisation lists were used for each centre and type of hypertension. | ||||||||
|
Darcie - Isradipine 2004 |
Brazil 1994 - 1997 prospective cohort |
A randomized, longitudinal, prospective study conducting at the Neonatal Pediatrics Service, Faculty of Medicine, University of São Paulo. | Newborns of hypertensive mothers treated with isradipine (5 mg twice a day) for at least 2 weeks before the delivery. |
unexposed, sick
Newborns of hypertensive mothers whose hypertension was controlled with diet only (without antihypertensive medication), for a minimum period of 2 weeks. |
late pregnancy | 39 / 14 | Study considered as a prospective cohort because no precision indicating that a randomization was carried out. | |
| This was a randomized, longitudinal, prospective study comparing 3 groups of patients according to the type of maternal treatment. => Not otherwise specified => Considered as a prospective cohort because no precision indicating that a randomization was carried out. | ||||||||
|
Fisher b - Calcium inhibitors (Controls unexposed, disease free) 2018 |
USA 1997 - 2011 retrospective cohort |
A retrospective cohort study using data on National Birth Defects Prevention Study (NBDPS) singleton controls, USA. | Mother with hypertension (chronic or pregnancy-related) that reported use of Calcium channel blocker at any time during the month before pregnancy until delivery. |
unexposed, disease free
Normotensive mothers who did not report taking an antihypertensive medication during pregnancy. |
during pregnancy (anytime or not specified) | 18 / 10050 | Most (83.0%) mothers who began using an antihypertensive medication before or during the first trimester continued use in the second trimester or later (data not shown). | |
| Trained interviewers collected data via telephone interview within 24 months of the infant’s birth. The interview included questions on medication use during the 3 months before pregnancy until delivery. | ||||||||
|
Fisher b - Calcium inhibitors (Controls unexposed, sick) 2018 |
USA 1997 - 2011 retrospective cohort |
A retrospective cohort study using data on National Birth Defects Prevention Study (NBDPS) singleton controls, USA. | Mother with hypertension (chronic or pregnancy-related) that reported use of Calcium channel blocker at any time during the month before pregnancy until delivery. |
unexposed, sick
Mother with untreated hypertension (chronic or pregnancy-related). |
during pregnancy (anytime or not specified) | 18 / 839 | Most (83.0%) mothers who began using an antihypertensive medication before or during the first trimester continued use in the second trimester or later (data not shown). Data extracted as a cohort. | |
| Trained interviewers collected data via telephone interview within 24 months of the infant’s birth. The interview included questions on medication use during the 3 months before pregnancy until delivery. | ||||||||
|
Fitton - Calcium Blockers 2021 |
Scotland 2010 - 2014 retrospective cohort (claims database) |
Linkage of 4 Scottish healthcare databases, held by the Information Statistics Division. | Pregnant women who were dispensed at least one prescription for a Calcium channel Blocker medication only during the 300 days before birth (whatever the indication). |
unexposed, disease free
All women who had a singleton birth during the same study period who were not dispensed antihypertensive medication during or 60 days following pregnancy, and who did not have an ICD-10 code for hypertension (chronic, gestational, or unspecified hypertension). |
during pregnancy (anytime or not specified) | 558 / 6066 | The majority of offspring were exposed to a beta-blocker only (58.66%, 4003 children), calcium channel blockers only (8.18%, 558 children), or a combination of more than one antihypertensive medication (20.53%, 1403 children). | |
| The Prescribing Information System which collects information on encashed prescriptions issued by primary care and dispensed from community pharmacies for all Scottish residents. | ||||||||
|
Fitton - Calcium blockers (Controls unexposed, disease free) 2020 |
Scotland 2010 - 2014 retrospective cohort (claims database) |
Linkage of 4 Scottish healthcare databases, held by the Information Statistics Division. | All women who had a singleton birth and who were dispensed at least one prescription for a Calcium channel blocker medication during the 300 days before birth (whatever the indication). |
unexposed, disease free
All women who had a singleton birth during the same study period who were not dispensed antihypertensive medication during or 60 days following pregnancy, and who did not have an ICD-10 code for hypertension (chronic, gestational, or unspecified hypertension). |
during pregnancy (anytime or not specified) | 167 / 250693 | The majority of offspring were exposed to a β-blocker only (58.66%, 4003 children), calcium channel blockers only (8.18%, 558 children), or a combination of >1 antihypertensive medication (20.53%, 1403 children). | |
| The Prescribing Information System which collects information on encashed prescriptions issued by primary care and dispensed from community pharmacies for all Scottish residents. | ||||||||
|
Fitton - Calcium blockers (Controls unexposed, sick) 2020 |
Scotland 2010 - 2014 retrospective cohort (claims database) |
Linkage of 4 Scottish healthcare databases, held by the Information Statistics Division. | All women who had a singleton birth and who were dispensed at least one prescription for a Calcium channel blocker medication during the 300 days before birth (whatever the indication). |
unexposed, sick
All women who had a singleton birth during the same study period, who had an ICD-10 code for hypertension (chronic, gestational, or unspecified hypertension) and who were not dispensed antihypertensive medication at any stage during or 60 days after pregnancy. |
during pregnancy (anytime or not specified) | 167 / 7971 | The majority of offspring were exposed to a β-blocker only (58.66%, 4003 children), calcium channel blockers only (8.18%, 558 children), or a combination of >1 antihypertensive medication (20.53%, 1403 children). | |
| The Prescribing Information System which collects information on encashed prescriptions issued by primary care and dispensed from community pharmacies for all Scottish residents. | ||||||||
|
Ishikawa - Amlodipine (Controls unexposed, disease free) 2023 |
Japan 2010 - 2019 retrospective cohort (claims database) |
A large administrative claims database from JMDC Inc. (Tokyo, Japan), which contained all the inpatient, outpatient, and pharmacy claims received from insurers. | Pregnant women with chronic hypertension and prescribed Amlodipine in the first trimester. |
unexposed, disease free
Pregnant women without hypertensive disorders in the first trimester. |
1st trimester | 44 / 74213 | ||
| A large administrative claims database from JMDC Inc. (Tokyo, Japan), which contained all the inpatient, outpatient, and pharmacy claims received from insurers. These claims include prescribed medications. | ||||||||
|
Ishikawa - Amlodipine (Controls unexposed, sick) 2023 |
Japan 2010 - 2019 retrospective cohort (claims database) |
A large administrative claims database from JMDC Inc. (Tokyo, Japan), which contained all the inpatient, outpatient, and pharmacy claims received from insurers. | Pregnant women with chronic hypertension and prescribed Amlodipine in the first trimester. |
unexposed, sick
Pregnant women chronic hypertension but no first-trimester antihypertensive prescriptions. |
1st trimester | 44 / 1007 | ||
| A large administrative claims database from JMDC Inc. (Tokyo, Japan), which contained all the inpatient, outpatient, and pharmacy claims received from insurers. These claims include prescribed medications. | ||||||||
|
Lennestal - Calcium inhibitors 2009 |
Sweden 1995 - 2006 population based cohort retrospective |
The Swedish Medical Birth Register, the Congenital Malformation Register, and the Hospital Discharge Register. | Infants born of women who reported the use of calcium-channel blockers (only) in early pregnancy, irrespective of the presence of a delivery diagnosis code of chronic hypertension. |
unexposed (general population or NOS)
Infants born of all women giving birth during the study period. |
early pregnancy | 217 / 1046843 | Overlapping: for beta-blockers, ARAII, ICE and calcium inhibitors, results of Kallen 2003 were totally overlapped by Lennestal 2009 a larger study: 1995 - 2006 with better adjustments) => Lennestal used rather than Kallen 2003. | |
| Maternal use of drugs during pregnancy based on the midwife interview at the first antenatal visit (90% of women attend before week 12) and therefore mainly refers to first trimester exposure. | ||||||||
|
Magee - Calcium blockers 1996 |
Canada, United Kingdom and USA 1984 - 1994 prospective cohort |
Five members of the Organization of Teratogen Information Services (TIS) (Motherisk Program, Pregnancy Healthline Philadelphia, TIS South Florida, Nebraska Teratogen Proiect, Indiana TIS) and TIS of London. | Pregnant women with first-trimester exposure to any calcium channel blockers. |
unexposed (general population or NOS)
Pregnant women with had been counseled about drugs or exposures not known or suspected of being teratogenic or fetotoxic (such as acetaminophenor dental x-rays), randomly selectedfrom the Motherisk database. |
at least 1st trimester | 78 / 78 | Indications: hypertension (57%, only 78% of which was essential hypertension), cardiac dysrhythmias (19%), migraine (16%), Raynaud's or systemic sclerosis (6%), and transient ischemic attack (3%). | |
| Standardized data collection forms were used to collect information by telephone or clinic interview, including drug exposure of interest (i.e., caIcium channel blocker dose, timing, toxicity, and indication for therapy) and concurrent drug or physical exposures. | ||||||||
|
Mito - Amlodipine 2019 |
Japan 2008 - 2016 retrospective cohort |
National Center for Child Health and Development (NCCHD, Tokyo), Osaka Women’s and Children’s Hospital (OWCH, Osaka), and National Cerebral and Cardiovascular Center (NCCC, Osaka), Japan. | Chronic hypertensive pregnant women who received Amlodipine, a calcium channel blocker during the first trimester (from estimated conception to 11 weeks and 6 days’ gestation). |
unexposed, sick
Chronic hypertensive pregnant women who did not receive any antihypertensive drugs. |
at least 1st trimester | 48 / 129 | Data versus Group O (pregnancies exposed to antihypertensives other than amlodipine (including other calcium channel blockers)) cannot be used, because calcium channel blockers in both groups. | |
| Data extracted from mothers’ electronic health records. | ||||||||
|
Parazzini - Nifedipine 1998 |
Italy 1992 - 1994 randomized controlled trial |
A randomised multicentre clinical trial, in 33 obstetric and nephrology centres, Gruppo di Studio Ipertensione in Gravidanza, Italy. | Pregnant women with hypertension randomly assigned to slow-release nifedipine, starting from 10 mg twice daily (increased up to 80 mg daily, if necessary). |
unexposed, sick
Pregnant women with hypertension randomly assigned to no treatment. |
2nd and/or 3rd trimester | 145 / 138 | For all malformations: overlapping between Parazzini et al., 1998 and Bortolus 2000 => use of the 1st one because it is based on a higher number of babies. | |
| Eligible women were randomly assigned treatment group. Group allocation was done by telephone to the Istituto Mario Negri in Bergamo. The randomisation list was generated by computer. Separate randomisation lists were used for each centre and type of hypertension. | ||||||||
|
Su - Calcium blockers (Controls unexposed, disease free) 2013 |
Taiwan Jan 2005 - Dec 2005 population based cohort retrospective |
The National Health Insurance Research Dataset (NHIRD) and the birth certificate registry. | Pregnant women with chronic hypertension (HTN) that have received a prescription of a calcium channels blocker for a period of at least 30 days during any time of their pregnancy. |
unexposed, disease free
Pregnant women with no diagnosis of chronic hypertension (HTN), randomly selected from the same cohort. |
during pregnancy (anytime or not specified) | 303 / 8181 | Women who used more than one type of anti-hypertensive drugs were excluded (n = 722). | |
| Data on anti-hypertensive drugs use come from the National Health Insurance Research Dataset (NHIRD), which consisted of all claims data during pregnancy. | ||||||||
|
Su - Calcium blockers (Controls unexposed, sick) 2013 |
Taiwan Jan 2005 - Dec 2005 population based cohort retrospective |
The National Health Insurance Research Dataset (NHIRD) and the birth certificate registry. | Pregnant women with chronic hypertension (HTN) that have received a prescription of a Calcium channels blocker for a period of at least 30 days during any time of their pregnancy. |
unexposed, sick
Pregnant women with chronic hypertension (HTN) who had not used any anti-hypertensive drugs. |
during pregnancy (anytime or not specified) | 303 / 1006 | Women who used more than one type of anti-hypertensive drugs were excluded (n = 722). | |
| Data on anti-hypertensive drugs use come from the National Health Insurance Research Dataset (NHIRD), which consisted of all claims data during pregnancy. | ||||||||
|
Vasilakis-Scaramozza - Calcium blockers 2013 |
United Kingdom (UK) 1991 - 2002 retrospective cohort |
The United Kingdom’s General Practice Research Database, from 368 general medical practices from throughout the United Kingdom. | Offspring of women with one or more prescriptions for a calcium channel blocker during early pregnancy, with a diagnosis of hypertension at any time prior to, or during, the pregnancy. |
unexposed (general population or NOS)
Offspring of women without exposure to antihypertensive drugs during pregnancy. |
1st trimester | 55 / 682 | ||
| Data were extracted from standardized clinical records for every patient within a general medical practice. These records describe notably prescribed drugs from each clinical visit. | ||||||||
|
Weber-Schoendorfer - Calcium blockers 2008 |
Finland, France, Germany, Israel, Italy, the Netherlands. 1986 - 2003 prospective cohort |
A multicenter (n = 11), prospective observational study of the European Network of Teratology Information Services (ENTIS). | Pregnant women with first- trimester exposure to calcium channel blockers. |
unexposed (general population or NOS)
Pregnant women who had been counseled during pregnancy about exposures known to be non-teratogenic. |
at least 1st trimester | 299 / 806 | Nifedipine (n=76), verapamil (n=62), diltiazem (n = 41) and amlodipine (n = 38). Indications (n = 272): hypertension (64.0%), cardiac arrhythmia (8.8%), migraine (8.8%), other cardiac diseases (7.7%), autoimmune diseases (6.6%), others (4.0%). | |
| A similarly structured questionnaire was used by all the centres to record the following data at the first contact during (early) pregnancy before the pregnancy outcome was known, including details of drug exposure (timing in pregnancy, dose, and duration). | ||||||||
|
Wide-Swensson - Isradipine 1995 |
Denmark and Sweden Not specified. randomized controlled trial |
A double-blind randomized controlled trial conducted at five centers in Sweden and one in Denmark (University hospital of Lund, Karolinska Institute, University hospital Arhus, University hospital of Uppsala, Hospital of Orebro and Malmo hospital). | Women with hypertension in pregnancy randomized to capsules of oral slow-release isradipine 5 mg twice daily. |
unexposed, sick
Women with hypertension in pregnancy randomized to capsules of placebo given twice daily. |
3rd trimester | 54 / 57 | Data related to Apgar scores not reported because the number of available data for the 2 groups not provided by authors. | |
| The patients were randomized by numbers. The randomization was done in blocks of 6 patients. Information as to which treatment each woman was given was stored in a sealed envelope, which was not opened until the study was completed. | ||||||||
| Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
|---|---|---|---|---|---|---|---|---|---|
|
Caton - Calcium blockers 2009 |
USA 1997 - 2003 case control |
The National Birth Defects Prevention Study (NBDPS). | Cases of cardiovascular malformations in live births, fetal deaths occurring after 20 weeks, and elective pregnancy terminations. | Live births without birth defects randomly selected from birth certificates or hospital discharge listings in the same geographic areas as the cases. | Data were collected via a computer-assisted telephone interview of infant's mothers within 24 months of the expected delivery date. Interviewers asked detailed questions about the diagnosis, timing, and treatment of high blood pressure. | 1st trimester | 5021 / 4796 | Overlapping: Fisher 2017 included data published by Caton 2009 based on a longer period study (1997-2011 versus 1977-2003), more cases and 2 control groups. Fisher 2017 was used rather than Caton 2009 (except for Ebstein anomaly and aorta coarctation). | |
| Case infants were identified from the population-based birth defects surveillance systems of the participating centers. Control infants were randomly selected from birth certificates or hospital discharge listings in the same geographic areas as the cases. | |||||||||
|
Fisher - Calcium blockers (Controls unexposed, disease free) 2017 |
USA 1997 - 2011 case control |
The National Birth Defects Prevention Study (NBDPS). | Cases of cardiovascular malformations in live births, fetal deaths occurring after 20 weeks, and elective pregnancy terminations. (According to Caton 2009) | Nonmalformed live births randomly selected from birth certificates or hospital discharge records in each study site. | Trained interviewers collected data via telephone interviews between 6 weeks and 24 months after the estimated delivery date. The interview included notably questions on medication use during the three months before pregnancy until delivery. | early pregnancy | 10625 / 11137 | Overlapping: Fisher 2017 included data published by Caton 2009 based on a longer period study (1997-2011 versus 1977-2003), more cases and 2 control groups. Fisher 2017 was used rather than Caton 2009 (except for Ebstein anomaly and aorta coarctation). | |
| Case infants were identified from the population-based birth defects surveillance systems of the participating centers. Control infants were randomly selected from birth certificates or hospital discharge listings in the same geographic areas as the cases. (According to Caton 2009) | |||||||||
|
Fisher - Calcium blockers (Controls unexposed, sick) 2017 |
USA 1997 - 2011 case control |
The National Birth Defects Prevention Study (NBDPS). | Cases of cardiovascular malformations in live births, fetal deaths occurring after 20 weeks, and elective pregnancy terminations. (According to Caton 2009) | Nonmalformed live births randomly selected from birth certificates or hospital discharge records in each study site. | Trained interviewers collected data via telephone interviews between 6 weeks and 24 months after the estimated delivery date. The interview included notably questions on medication use during the three months before pregnancy until delivery. | early pregnancy | 10625 / 11137 | Overlapping: Fisher 2017 included data published by Caton 2009 based on a longer period study (1997-2011 versus 1977-2003), more cases and 2 control groups. Fisher 2017 was used rather than Caton 2009 (except for Ebstein anomaly and aorta coarctation). | |
| Case infants were identified from the population-based birth defects surveillance systems of the participating centers. Control infants were randomly selected from birth certificates or hospital discharge listings in the same geographic areas as the cases. (According to Caton 2009) | |||||||||
|
Fisher a - Calcium blockers 2018 |
USA 1997 - 2011 case control |
The National Birth Defects Prevention Study, USA. | All cases (liveborn, stillborn after 20 weeks gestation, or induced abortions) with an eligible defect within the study time period and geographic areas. | Live births not affected by a birth defect randomly selected from birth certificates or hospital discharge records to represent the base population from which cases were selected in each study site. | Exposure information was collected via maternal self-report during a computer-assisted telephone interview administered between 6 weeks and 24 months after her estimated delivery date. Trained interviewers asked about medication use during the 3 months before pregnancy until delivery. | 1st trimester | 17038 / 11477 | For this study, authors analyzed birth defect case groups with at least 100 participants; and excluded congenital heart defects and hypospadias, as those case groups have been studied previously. | |
| Data were abstracted from medical record, birth certificates or hospital discharge records. | |||||||||
|
Nakhai-Pour - Calcium blockers 2010 |
Canada 1998 - 2003 nested case control |
The Quebec Pregnancy Registry, built with the linkage of three administrative databases: Regie de l’Assurance Maladie du Quebec (RAMQ); the hospital discharge database Med-Echo; and the Institut de la Statistique du Quebec (ISQ). | Mothers who gave birth to a baby with a major congenital malformation (1st study). Newborns small for gestational age (a birth weight less than the 10th percentile for that gestational age and gender according to the Canadian gender-specific references) (2nd study). | Mothers who gave birth to babies without any major or minor congenital malformation diagnosed during the same time period (1st study). Newborns not small for gestational age (2nd study). | The Régie de l’Assurance Maladie du Québec (RAMQ) provides prospectively collected data on filled prescriptions. | 1st trimester, 2nd and/or 3rd trimester | 4155 / 54878 | Major congenital malformations: number of cases: 4,155; number of controls: 54,878.Small-for-gestational-age: number of cases: 7,445; number of controls: 48,889. | |
| The three administrative databases provided data on physician-based diagnosis (according to ICD-9), physician and emergency department visits and admissions, procedures and hospitalizations, health care providers, birth weight and gestational age for live births and stillbirths. | |||||||||
|
Sorensen - Calcium blockers 2001 |
Hungary 1980 - 1996 case control |
The Hungarian Congenital Abnormality Registry, a population-based registry. | Cases with isolated and multiple congenital abnormalities. | Matched newborn infants without congenital abnormalities selected from the National Birth Registry of the Central Statistical Office. | Drug intake was recorded if stated in the self- administered questionnaires (immediately after notification) and/or reported by the perinatal care physician in the personal prenatal care logbook. | 1st trimester | 22865 / 38151 | Three less well-defined mild defects were excluded: congenital dislocation of the hip based on the Ortolani click, congenital inguinal hernia and hemangiomas. Syndromes of known origin were also excluded (e.g. Down Syndrome or rubella). | |
| Notification of malformed offspring is compulsory for physicians and there are three main sources: 1) obstetricians, 2) pediatricians (who work in the neonatal units, obstetric clinics) and 3) consultants at six prenatal diagnostic centers where severe fetal defects are diagnosed. | |||||||||
|
Van Gelder - Calcium blockers 2015 |
USA and Canada 1998 - 2010 case control |
The Slone Birth Defects Study, also known as the Pregnancy Health Interview Study, a multisite case–control. | Liveborn or stillborn infants with one of the selected birth defects without chromosomal abnormalities or associated syndromes. | Liveborn infants without birth defects randomly selected from state-wide birth records or from study hospitals covering the geographic catchment areas where the cases were identified. | Within 6 months after delivery, trained research nurses interviewed the mothers of case and control infants by telephone, in English or Spanish, about details of medication use in the 2 months before pregnancy until the end of pregnancy. | 1st trimester, 2nd and/or 3rd trimester | 5568 / 7253 | Any use of antiadrenergic agents, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, calcium channel blockers, diuretics, or direct vasodilators at any time from the month before pregnancy to the end of pregnancy. | |
| Cases and controls identified through birth defects registries (Massachusetts and parts of New York State) or from participating hospitals in the areas surrounding Boston (MA), Philadelphia (PA), San Diego (CA), and Toronto (Canada). | |||||||||
|
Van Zutphen - Calcium blockers 2014 |
USA 1997 - 2009 case control |
The National Birth Defects Prevention Study, USA. | All cases (liveborn, stillborn after 20 weeks gestation, or induced abortions) with severe hypospadias (ie, subcoronal or penile, scrotal, or perineal meatal opening) diagnosed at the time of physical examination, surgery, or autopsy. | Male live births without birth defects randomly selected from birth certificates or hospital discharge listings in the same population as the case neonates. | Antihypertensive medication use were collected by trained interviewers who conducted maternal telephone interviews within 24 months of delivery. | early pregnancy | 2131 / 5129 | Mothers reporting antihypertensive medications for the treatment of other indications (eg, b-blockers for migraine headaches) were excluded from the analyses. Overlapping: Caton 2008 (1997-2002) totally included in Van Zutphen 2014 (1997-2009). | |
| Data were abstracted from medical record, birth certificates or hospital discharge records. To confirm cases, clinical geneticists reviewed data, including consultations (urology, endocrinology, and genetic), reports (operative, pathology, and autopsy), and radiographic results. | |||||||||
|
Zarante - Nifedipine 2009 |
Colombia 2001- 2006 case control |
The Institute of Human Genetics of the Pontificia Universidad Javeriana, an active member of the Latin-American Collaborative Study of Congenital Malformations (ECLAMC) which is an international registry of congenital malformations . | All newborns and stillborns of weight >500 g that presented only one craniofacial malformation, not associated with any other congenital condition. | The next non-malformed same sex child born in the same hospital. | Information collected in 10 Colombian hospitals (NOS). | during pregnancy (anytime or not specified) | 374 / 728 | Exclusion of patients with Down syndrome, Potter sequence, VACTERL association, and other unspecified multiple malformations. | |
| Information collected in 10 Colombian hospitals (NOS). | |||||||||
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;
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