| 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 |
|---|---|---|---|---|---|---|---|---|
|
Boskovic (control unexposed, disease free) 2005 |
Canada 1997 - 2004 prospective cohort |
The Motherisk Program | Pregnancies exposed to beta interferon. |
unexposed, disease free
Pregnancies of women counseled for on the treatment of Nausea and Vomiting (NVP) symptoms. |
1st trimester | 23 / 20 | 'In 21 gestations (all with MS) interferon therapy was terminated during the first trimester of pregnancy.' | |
| During the initial contact, pregnancy information was collected. This included general information regarding maternal health and any possible xenobiotic exposure, including drug therapy. All xenobiotic exposures throughout gestation were also recorded after delivery. | ||||||||
|
Boskovic (control unexposed, sick) 2005 |
Canada 1997 - 2004 prospective cohort |
The Motherisk Program | Pregnancies exposed to beta interferon. |
unexposed, sick
Pregnancies of women that discontinued beta interferon or Copaxone prior to conception. |
1st trimester | 23 / 21 | 'In 21 gestations (all with MS) interferon therapy was terminated during the first trimester of pregnancy.' | |
| During the initial contact, pregnancy information was collected. This included general information regarding maternal health and any possible xenobiotic exposure, including drug therapy. All xenobiotic exposures throughout gestation were also recorded after delivery. | ||||||||
|
Colvin - IFN beta1b 2010 |
Australia 2002 - 2005 retrospective cohort (claims database) |
Linkage between administrative records of medicines dispensed in pregnancy (Pharmaceutical Benefits Scheme (PBS) and health administrative data. | Interferon beta-1b dispensed from 14 days after the last menstrual period (LMP) to the end of first trimester or to the end of the pregnancy event. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
All other births (those births to women dispensed a Pharmaceutical Benefits Scheme (PBS) medicine or not). |
1st trimester | 7 / 106067 | Category D or X medicines also studied. Total nb of unexposed: 106067=106 074-7. Birth defect: structural or functional abnormality. Most minor defects are not recorded in the BDR. Of all cases, about 90% have at least one major birth defect. | |
| The national Pharmaceutical Benefits Scheme, with around 80% of prescriptions dispensed in Australia. | ||||||||
|
Finkelsztejn (control exposed to Glatiramer) 2011 |
Brazil 2008 - ? retrospective cohort |
A database on MS and pregnancy compiled by researchers in Brazil | Early exposure to beta interferon during pregnancy (This is a subgroup of exposure among the exposed group considered in the study). |
exposed to other treatment, sick
Early exposure to glatiramer acetate during pregnancy (This is a subgroup of exposure among the exposed group considered in the study). |
early pregnancy | 69 / 20 | Fragoso 2009 was updated by Finkelsztejn 2011. | |
| Data were obtained from medical records of patients attending regular consultations with their neurologists. | ||||||||
|
Finkelsztejn (control unexposed, sick) 2011 |
Brazil 2008 - ? retrospective cohort |
A database on MS and pregnancy compiled by researchers in Brazil | Early exposure to beta interferon during pregnancy (This is a subgroup of exposure among the exposed group considered in the study). |
unexposed, sick
No exposure to MS medications during pregnancy. |
early pregnancy | 69 / 43 | Fragoso 2009 was updated by Finkelsztejn 2011. | |
| Data were obtained from medical records of patients attending regular consultations with their neurologists. | ||||||||
|
Fragoso a (control exposed to Glatiramer) 2013 |
Brazil Not specified retrospective cohort |
The Brazilian database of pregnancy and multiple sclerosis (MS), a well-established large national registry. | The drug-exposure group was considered to be at least 2 weeks of Interferon beta use at any time after conception. (This is a subgroup of exposure among the exposed group considered in the study). |
exposed to other treatment, sick
The drug-exposure group was considered to be at least 2 weeks of Glatiramer acetate use at any time after conception. (This is a subgroup of exposure among the exposed group considered in the study). |
during pregnancy (anytime or not specified) | 39 / 39 | 'Patients who were receiving any other medication that might influence the results were excluded.' | |
| Data were obtained from the medical records of patients attending regular consultations with their neurologists. | ||||||||
|
Fragoso a (control unexposed, sick) 2013 |
Brazil Not specified retrospective cohort |
The Brazilian database of pregnancy and multiple sclerosis (MS), a well-established large national registry. | The drug-exposure group was considered to be at least 2 weeks of Interferon beta use at any time after conception. (This is a subgroup of exposure among the exposed group considered in the study). |
unexposed, sick
The control group consisted of women with MS who were not exposed to any drugs for at least 3 months prior to conception and remained unexposed at all times during pregnancy. |
during pregnancy (anytime or not specified) | 39 / 95 | 'Patients who were receiving any other medication that might influence the results were excluded.' | |
| Data were obtained from the medical records of patients attending regular consultations with their neurologists. | ||||||||
|
Fragoso b (control exposed to Glatiramer) 2013 |
Brazil, United Kingdom, Mexico and Argentina. Not specified retrospective cohort |
An open and internationally-based attempt to create a database for studying exposure to DMT during pregnancy | MS patients with a minimum of eight weeks of continuous exposure to Interferon beta at the start of pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). |
exposed to other treatment, sick
MS patients with a minimum of eight weeks of continuous exposure to Glatiramer acetate at the start of pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). |
at least 1st trimester | 17 / 41 | 'The mean duration of drug exposure during pregnancy was 18.4 ± 13.2 weeks (range = 8–40 weeks).' | |
| Data collection was retrospective, using patients’ medical records. Whenever data were missing from the medical records, the physician in charge of the case contacted the patient in order to obtain missing details. Only patients actually seen by the authors of this study were included. | ||||||||
|
Fragoso b (control unexposed, sick) 2013 |
Brazil, United Kingdom, Mexico and Argentina. Not specified retrospective cohort |
An open and internationally-based attempt to create a database for studying exposure to DMT during pregnancy | MS patients with a minimum of eight weeks of continuous exposure to Interferon beta at the start of pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). |
unexposed, sick
MS patients with no exposure to any Disease Modifying Treatment for a minimum of three months prior to pregnancy. |
at least 1st trimester | 17 / 89 | 'The mean duration of drug exposure during pregnancy was 18.4 ± 13.2 weeks (range = 8–40 weeks).' | |
| Data collection was retrospective, using patients’ medical records. Whenever data were missing from the medical records, the physician in charge of the case contacted the patient in order to obtain missing details. Only patients actually seen by the authors of this study were included. | ||||||||
|
Giannini (control exposed to Glatiramer) 2012 |
Italy 2002 - 2008 prospective cohort |
The MS Study Group of the Italian Neurological Society: 21 participating sites representing the main Italian Multiple sclerosis (MS) Centers. | Pregnancies in patients who had discontinued the Interferon beta less than four weeks from conception. |
exposed to other treatment, sick
Pregnancies in patients who had discontinued the Glatiramer acetate less than four weeks from conception. |
early pregnancy | 88 / 17 | ||
| Patients were regularly followed-up every six months and in the case of relapse. Data were gathered by the neurologist using a standardized information form, notably information on the pregnancies occurring during the study period, focusing on in utero exposure to pharmacological therapies. | ||||||||
|
Giannini (control unexposed, sick) 2012 |
Italy 2002 - 2008 prospective cohort |
The MS Study Group of the Italian Neurological Society: 21 participating sites representing the main Italian Multiple sclerosis (MS) Centers. | Pregnancies in patients who had discontinued the Interferon beta less than four weeks from conception. |
unexposed, sick
Pregnancies in patients who had discontinued the Glatiramer acetate at least four weeks from the conception or who had never been treated with DMTs. |
early pregnancy | 88 / 318 | ||
| Patients were regularly followed-up every six months and in the case of relapse. Data were gathered by the neurologist using a standardized information form, notably information on the pregnancies occurring during the study period, focusing on in utero exposure to pharmacological therapies. | ||||||||
|
Lu (control exposed to Glatiramer) 2012 |
Canada 1998 - 2009 retrospective cohort |
Two prospectively collated databases, the British Columbia MS (BCMS) database and the BC Perinatal Database Registry (BCPDR) | Births to women with RRMS exposed to Interferon beta within 1 month prior to conception and/or during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). |
exposed to other treatment, sick
Births to women with RRMS exposed to Glatiramer acetate within 1 month prior to conception and/or during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). |
during pregnancy (anytime or not specified) | 15 / 6 | ||
| The data on MS and DMD use was generated prospectively by MS specialist neurologists and collected from four MS clinics in BC (Kelowna, Prince George, Vancouver, Victoria). | ||||||||
|
Lu (control unexposed, sick) 2012 |
Canada 1998 - 2009 retrospective cohort |
Two prospectively collated databases, the British Columbia MS (BCMS) database and the BC Perinatal Database Registry (BCPDR) | Births to women with RRMS exposed to Interferon beta within 1 month prior to conception and/or during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). |
unexposed, sick
Births to women with RRMS who were DMD naïve (no exposure to a DMD disease-modifying drug (GA or IFNb) before or during pregnancy) or who were previously treated (used a DMD before pregnancy, but discontinued treatment at least one month prior to conception). |
during pregnancy (anytime or not specified) | 15 / 397 | ADDITION of the two unexposed sick control groups (used a DMD before pregnancy, but discontinued treatment at least one month prior to conception AND DMD naïve). | |
| The data on MS and DMD use was generated prospectively by MS specialist neurologists and collected from four MS clinics in BC (Kelowna, Prince George, Vancouver, Victoria). | ||||||||
|
Nguyen (control exposed to Glatiramer) 2019 |
International 2005 - 2016 prospective cohort |
The Multiple Sclerosis (MS) Base Registry is a large, international observational cohort study, with long-term prospectively collected data. | Pregnancies occurring during Interferon beta (all) therapy. (This is a subgroup of exposure among the exposed group considered in the study). |
exposed to other treatment, sick
Pregnancies occurring during Glatiramer acetate therapy. (This is a subgroup of exposure among the exposed group considered in the study). |
during pregnancy (anytime or not specified) | 350 / 137 | ||
| Data in the MSBase registry, including prospective pregnancy data, is entered in real time or near real time, as part of routine clinical visits. Information collected included: disease-modifying therapies exposure before and during pregnancy. | ||||||||
|
Nguyen (control unexposed, sick) 2019 |
International 2005 - 2016 prospective cohort |
The Multiple Sclerosis (MS) Base Registry is a large, international observational cohort study, with long-term prospectively collected data. | Pregnancies occurring during Interferon beta (all) therapy. (This is a subgroup of exposure among the exposed group considered in the study). |
unexposed, sick
Pregnancies not exposed to disease-modifying therapies (DMTs) (pregnancy occurring within a year of DMT discontinuation or without DMT exposure in the prior year). |
during pregnancy (anytime or not specified) | 350 / 886 | ||
| Data in the MSBase registry, including prospective pregnancy data, is entered in real time or near real time, as part of routine clinical visits. Information collected included: disease-modifying therapies exposure before and during pregnancy. | ||||||||
|
Portaccio 2018 |
Italy 2002 - 2008 prospective cohort |
The MS Study Group of the Italian Neurological Society: 21 participating sites representing the main Italian Multiple sclerosis (MS) Centers. | Pregnancies in MS patients who had discontinued the Interferon beta less than four weeks from conception. |
unexposed, sick
Pregnancies in MS patients who had discontinued the DMT before the conception or who had never been treated with DMTs. |
early pregnancy | 88 / 318 | ||
| All the patients were regularly followed up every 6 months and in the case of relapse. | ||||||||
|
Thiel (control unexposed, sick) 2016 |
Germany 2008 - 2013 prospective cohort |
The nationwide German Multiple Sclerosis and Pregnancy Registry | IFN-beta-exposed pregnancies were defined as last injection administered after the last menstrual period (LMP). |
unexposed, sick
Pregnant women unexposed to disease-modifying therapies (never treated with DMTs or stop 0-4 months before pregnancy according to the DMT). |
early pregnancy | 251 / 194 | ' The vast majority (n = 246; 98.01%) of IFN- beta-exposed patients stopped treatment during the first trimester of pregnancy, mostly (n=179, 71%) with the detection of pregnancy before gw 6.' | |
| Women were asked to complete a structured, interviewer-administered questionnaire primarily by phone or in-person during visits to our outpatient clinic after study entry. During pregnancy a detailed history of MS (diagnosis, disease activity, treatments) are obtained. | ||||||||
|
Weber-Schoendorfer (control exposed to Glatiramer) 2009 |
Germany 1996 - 2007 prospective cohort |
The Teratology Information Service (TIS), Berlin | Women exposed groups to Interferon-β during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). |
exposed to other treatment, sick
Women exposed groups to Glatiramer acetate during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). |
at least 1st trimester | 69 / 31 | 'The main point of interest was the rate of major birth defects' | |
| A structured questionnaire administered to physicians or mothers for details of drug exposure (timing in pregnancy, dose, and duration) at the first contact during (early) pregnancy, before the pregnancy outcome was known. | ||||||||
|
Weber-Schoendorfer (control unexposed, disease free) 2009 |
Germany 1996 - 2007 prospective cohort |
The Teratology Information Service (TIS), Berlin | Women exposed groups to Interferon-β during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). |
unexposed, disease free
Pregnant women who had been counseled during pregnancy after exposures known to be nonteratogenic. |
at least 1st trimester | 69 / 1556 | 'The main point of interest was the rate of major birth defects' | |
| A structured questionnaire administered to physicians or mothers for details of drug exposure (timing in pregnancy, dose, and duration) at the first contact during (early) pregnancy, before the pregnancy outcome was known. | ||||||||
|
Weber-Schoendorfer (control unexposed, sick) 2009 |
Germany 1996 - 2007 prospective cohort |
The Teratology Information Service (TIS), Berlin | Women exposed groups to Interferon-β during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). |
unexposed, sick
Multiple sclerosis patients who neither had taken the immunomodulatory drugs under study nor were exposed to known teratogens such as classical anticonvulsants or phenprocoumon, although some members of this group were given glucocorticoids for a relapse. |
at least 1st trimester | 69 / 64 | 'The main point of interest was the rate of major birth defects' | |
| A structured questionnaire administered to physicians or mothers for details of drug exposure (timing in pregnancy, dose, and duration) at the first contact during (early) pregnancy, before the pregnancy outcome was known. | ||||||||
| Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
|---|
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;
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