Mebendazole - Medication and Pregnancy KB

Mebendazole

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
Akpan 2018	Nigeria Jan - Dec 2015 randomized controlled trial	A randomised placebo-controlled study at the University of Calabar Teaching Hospital Antenatal Clinic, Nigeria.	Pregnant women that receive a single 500 mg oral dose of Mebendazole plus a daily iron supplement (60 mg elemental iron) and folic acid.	unexposed, sick Pregnant women that receive a single dose placebo plus a daily iron supplement (60 mg elemental iron) and folic acid.	2nd trimester	300 / 260	Study on the efficacy of azole in an obstetrical indication, including the intrauterine deaths and/or late pregnancy and/or neonatal outcomes that are studied as efficacy criteria rather than safety one. => Not reported here.
Akpan 2018	Nigeria Jan - Dec 2015 randomized controlled trial		The administration of the anthelmintics was done by directly observed therapy (DOT) to ensure 100% compliance. Computer-generated random numbers were used for sampling.		2nd trimester	300 / 260
De Silva 1999	Sri Lanka 1996 - 1997 retrospective cohort	Two state-run tertiary-care hospitals in Sri Lanka.	Babies born to mothers who had taken mebendazole during the current pregnancy.	unexposed (general population or NOS) Babies born to mothers who had not taken any anthelmintic during pregnancy.	1st trimester, during pregnancy (anytime or not specified)	5275 / 1737	Study on the efficacy of azole in an obstetrical indication, including the intrauterine deaths and/or late pregnancy and/or neonatal outcomes that are studied as efficacy criteria rather than safety one. => Not reported here.
De Silva 1999	Sri Lanka 1996 - 1997 retrospective cohort	Two state-run tertiary-care hospitals in Sri Lanka.	All women were questioned directly about their use of anthelmintics during that pregnancy by a questionnaire administered during the post partum by a trained research assistants. Antenatal notes were consulted whenever possible to confirm prescription of mebendazole and the date of prescription.		1st trimester, during pregnancy (anytime or not specified)	5275 / 1737
Diav-Citrin 2003	Israel 1988 - 1999 prospective cohort	Israeli Teratogen Information Service	Pregnant women who were exposed to mebendazole in pregnancy.	unexposed (general population or NOS) Pregnant women who had been counseled about exposures (ie, medications, low- dose irradiation) not known to be teratogenic or embryofetotoxic.	1st trimester, during pregnancy (anytime or not specified)	192 / 192	Most of the women in the cohort were exposed to mebendazole during the first trimester (71.5%) of pregnancy, 21.5% of the women were exposed during the second trimester, and 7.0% of the women were exposed during the third trimester.
Diav-Citrin 2003	Israel 1988 - 1999 prospective cohort	Israeli Teratogen Information Service	Details of the exposure were collected during the pregnancy, with a structured questionnaire administered by telephone, including exposure details (mebendazole dose, duration, timing in pregnancy, and indication for therapy), and concurrent drug exposures.		1st trimester, during pregnancy (anytime or not specified)	192 / 192
Gyorkos 2006	Peru April - Nov 2003 randomized controlled trial	A large double-blind, placebo-controlled, randomized trial conducted in Iquitos, Peru.	Pregnant women recruited in their second trimester and randomized to receive a single oral 500-mg dose of mebendazole (Nemasole).	unexposed, sick Pregnant women recruited in their second trimester and randomized to receive a single of placebo.	2nd trimester	522 / 520	Study on the efficacy of azole in an obstetrical indication, including the intrauterine deaths and/or late pregnancy and/or neonatal outcomes that are studied as efficacy criteria rather than safety one. => Not reported here.
Gyorkos 2006	Peru April - Nov 2003 randomized controlled trial		The mebendazole and placebo were administered by the interviewer to the women at the time of the initial interview. Interviewers were blind to treatment assignment.		2nd trimester	522 / 520
Torp-Pedersen (Controls exposed to Pyrviniumn) 2016	Denmark 1997 - 2007 population based cohort retrospective	Five Danish national registers: The Danish Fertility Database, The Danish National Hospital Register, The Danish National Prescription Register, The Income Statistics Register and The Populations Education Register.	Redemption of a prescription for Mebendazole during pregnancy.	exposed to other treatment, sick Redemption of a prescription for Pyrviniumn during pregnancy.	1st trimester, during pregnancy (anytime or not specified)	2567 / 1588
Torp-Pedersen (Controls exposed to Pyrviniumn) 2016	Denmark 1997 - 2007 population based cohort retrospective		The Danish National Prescription Register which includes individual level information on all prescriptions from Danish pharmacies.		1st trimester, during pregnancy (anytime or not specified)	2567 / 1588
Torp-Pedersen (Controls unexposed, NOS) 2016	Denmark 1997 - 2007 population based cohort retrospective	Five Danish national registers: The Danish Fertility Database, The Danish National Hospital Register, The Danish National Prescription Register, The Income Statistics Register and The Populations Education Register.	Redemption of a prescription for mebendazole during pregnancy.	unexposed (general population or NOS) No redemption of a prescription for mebendazole or pyrvinium during pregnancy.	1st trimester, during pregnancy (anytime or not specified)	2567 / 708982
Torp-Pedersen (Controls unexposed, NOS) 2016	Denmark 1997 - 2007 population based cohort retrospective		The Danish National Prescription Register which includes individual level information on all prescriptions from Danish pharmacies.		1st trimester, during pregnancy (anytime or not specified)	2567 / 708982

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
Acs 2005	Hungary 1980 - 1996 case control	Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA)	Newborn infants with congenital abnormality. Exclusions included some mild congenital abnormalities, minor variants, and congenital abnormality syndromes of Mendelian and chromosomal origin.	Newborn infants without congenital abnormality.	Exposure data collected from 3 sources: a post-paid structured questionnaire sent to the parents requesting drugs taken during pregnancy, according to gestational months; maternal prenatal care logbook (in which obstetricians must record all prescribed drugs); nurses visited non-responding families.	1st trimester	22843 / 38151	Route of administration: only mebendazole oral tablets were available.
Acs 2005	Hungary 1980 - 1996 case control		The Hungarian Congenital Abnormality Registry (HCAR), in which notification by physicians of cases with Congenital anomalies is mandatory (including infant deaths and usual stillborn fetuses). Controls were selected from the National Birth Registry of the Central Statistical Office.			1st trimester	22843 / 38151

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

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