Domperidone - Medication and Pregnancy KB

Domperidone

Exposed non-exposed, cohort studies

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
Choi 2013	Korea Not specified prospective cohort	Korean Motherisk Program	Pregnant women treated with domperidone for controlling gastrointestinal symptoms.	unexposed (general population or NOS) Pregnant women who were not exposed to any other teratogenic medication.	1st trimester	120 / 212
Choi 2013	Korea Not specified prospective cohort	Korean Motherisk Program	At the initial visit, participants completed a questionnaire about their personal and medical history, and were followed-up until completion of their pregnancy.		1st trimester	120 / 212
Cottin (Control exposed to other treatments) 2015	France 1995 - 2014 prospective cohort	Teratology information service (TIS): French pharmacovigilance centers and the Centre de Référence sur les Agents Tératogènes (CRAT)	Pregnant women exposed to domperidone within 4 to 12 weeks after the last menstrual period and not exposed to any other antiemetic drug during embryogenesis.	exposed to other treatment, sick Pregnant women who were taking other antiemetic drugs (metoclopramide or doxylamine).	1st trimester	124 / 97	Raw data provided by personal communication of the authors.
Cottin (Control exposed to other treatments) 2015	France 1995 - 2014 prospective cohort		Not specified.		1st trimester	124 / 97	Raw data provided by personal communication of the authors.
Cottin (Controls unexposed, disease free) 2015	France 1995 - 2014 prospective cohort	Teratology information service (TIS): French pharmacovigilance centers and the Centre de Référence sur les Agents Tératogènes (CRAT)	Pregnant women exposed to domperidone within 4 to 12 weeks after the last menstrual period and not exposed to any other antiemetic drug during embryogenesis.	unexposed, disease free Pregnant women who were counselled after a non-teratogenic exposure during the same period	1st trimester	124 / 248	Raw data provided by personal communication of the authors.
Cottin (Controls unexposed, disease free) 2015	France 1995 - 2014 prospective cohort		Not specified.		1st trimester	124 / 248	Raw data provided by personal communication of the authors.

Case-control studies

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Fejzo 2015	USA 2007 - 2011 case control	A part of a larger investigation evaluating the 44 genetics and epidemiology of Hyperemesis gravidarum (HG)	Children exposed to hyperemesis gravidarum (HG) with neurodevelopmental delay.	Children exposed to hyperemesis gravidarum (HG) with a good outcome.	Participants were asked to submit their medical records and complete an online survey regarding treatment.	during pregnancy (anytime or not specified)	138 / 174	Main analysis: case control related to the impact of the HG illness (treated or not) on child outcomes. Then impact of 37 medications/treatments (1st and/or 2nd trimester) on child outcome was investigated (none was significantly associated with delay).
Fejzo 2015	USA 2007 - 2011 case control		Participants were asked to submit their medical records and complete an online survey regarding outcomes. A follow-up survey was administered on the diagnosis of childhood emotional, behavioral, and learning disorders.			during pregnancy (anytime or not specified)	138 / 174
Fejzo 2013	USA 2007 - 2011 case control	A part of a larger investigation evaluating the genetics and epidemiology of Hyperemesis gravidarum (HG).	Pregnant women with hyperemesis gravidarum (HG) who have negative outcomes (birth weight less than 10%, perinatal mortality, and/or preterm birth (<37 weeks)).	Pregnant women with hyperemesis gravidarum (HG) who have positive outcomes.	Participants were asked to submit their medical records and complete an online survey regarding treatment. The majority of participants, both cases and controls, joined the study and began the survey during their pregnancies.	during pregnancy (anytime or not specified)	43 / 211	Comparison of use of various medications/treatments in the two groups (43 HG participants with an adverse outcome compared to 211 HG participants with a good outcome).
Fejzo 2013	USA 2007 - 2011 case control		Participants were asked to submit their medical records and complete an online surveyregarding outcomes. The majority of participants, both cases and controls, were automatically prompted to complete the survey on outcome following their due date.			during pregnancy (anytime or not specified)	43 / 211

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

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