Mebendazole

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Acs, 2005	case control	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.	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.	Two controls were matched to every case according to sex, week in the year when the case subject was born and district of parents’ residence. Adjusted for birth order, maternal age, employment status and maternal disorders.
Akpan, 2018	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.	All the participants in both the treatment and the placebo groups were then followed up to term and delivery. The maternal and perinatal outcomes were documented.	No adjustment. Randomisation.
De Silva, 1999	retrospective cohort	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.	All babies were examined by a paediatric house-officer for congenital defects before discharge from hospital. All babies in whom the house-officer suspected an anomaly were then examined by a consultant paediatrician who confirmed or excluded the diagnosis.	None.
Diav-Citrin, 2003	prospective cohort	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.	A structured questionnaire administered to the mother by phone to obtain details on the pregnancy outcome, gestational age at delivery, birth weight, and major or minor birth defects. In case of malformation, a certified pediatrician contacted the mother for details and verification.	Controls matched to the mebendazole-treated women by maternal age, gestational age at call, and year of call.
Gyorkos, 2006	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.	Birth outcome and birth weight were recorded at the hospital or the woman’s home (in the case of a domiciliary birth, the baby was observed by the research obstetriz). The attending physician and nurses at delivery were blind to the treatment assignment of the woman.	No adjustment. Randomisation.
Torp-Pedersen (Controls exposed to Pyrviniumn), 2016	population based cohort retrospective	The Danish National Prescription Register which includes individual level information on all prescriptions from Danish pharmacies.	The Danish National Hospital Register.	No adjustment for this group of comparison.
Torp-Pedersen (Controls unexposed, NOS), 2016	population based cohort retrospective	The Danish National Prescription Register which includes individual level information on all prescriptions from Danish pharmacies.	The Danish National Hospital Register.	Adjusted for: maternal age at conception, parity, income, level of education and smoking. In the model analysing the risk of stillbirth and neonatal mortality, it was furthermore adjusted for gestational age.

master protocol