Albendazole - Medication and Pregnancy KB

Albendazole

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
Celik 2018	Turkey 2015 - 2017 retrospective cohort	The registry systems of two hospitals (Yuzuncu Yıl University and Erics state hospital), Van, Turkey	Pregnant patients treated with albendazole following diagnosis of hydatid disease (HD) (without surgery).	unexposed, sick Pregnant patients without treatment for hydatid disease (HD) (neither albendazole, nor surgery, nor percutaneous aspiration-irrigation and re-aspiration).	1st trimester	1 / 18
Celik 2018	Turkey 2015 - 2017 retrospective cohort		Data were obtained from the registry systems of two hospitals and from medical survey charts developed for pregnant women with hydatid disease (HD).		1st trimester	1 / 18
Choi 2017	South Korea Not specified prospective cohort	The Korean Motherisk Program.	Pregnant women who were inadvertently exposed to albendazole in the first trimester of pregnancy (single dose of 200 or 400 mg).	unexposed, disease free Pregnant women who were not exposed to any medication.	1st trimester	124 / 382
Choi 2017	South Korea Not specified prospective cohort	The Korean Motherisk Program.	Each participant was given a questionnaire regarding exposure to alcohol, cigarettes or any other medication at recruitment and at every visit until delivery, or until lost to follow-up.		1st trimester	124 / 382
Gyapong 2003	Ghana Not specified retrospective cohort	An electronic database of all women in 16 communities, Ahanta West District, Ghana.	Inadvertent exposure to albendazole and ivermectin drugs in early pregnancy.	unexposed, sick No exposure to albendazole and ivermectin drugs in early pregnancy.	early pregnancy	50 / 293
Gyapong 2003	Ghana Not specified retrospective cohort		All women were visited and interviewed to find out if they had received the drugs. During the interviews, the women were also asked if they had been pregnant during the time of drug distribution, and/or if they had had a child since.		early pregnancy	50 / 293
Mpairwe (Controls exposed to Praziquantel) 2011	Uganda 2003 - 2005 randomized controlled trial	A randomised, double-blind, placebo-controlled trial at Entebbe Hospital.	Pregnant women receiving a single dose of oral albendazole (400 mg) and placebo.	exposed to other treatment, sick Pregnant women receiving a single dose of Praziquantel (40 mg/kg) and placebo.	2nd and/or 3rd trimester	625 / 628	(Ndibazza 2010 ; Webb 2011 and Mpairwe 2011 => same placebo-controlled, with different outcomes, except for Stillbirths (overlapping) for which the data provided by Ndibazza 2010 was reported (rather than Mpairwe 2011) because these data were adjusted.
Mpairwe (Controls exposed to Praziquantel) 2011	Uganda 2003 - 2005 randomized controlled trial		Pregnant women were allocated to one of the four treatment arms according to a random sequence. Participants and staff were blinded to treatment allocation.		2nd and/or 3rd trimester	625 / 628
Mpairwe (Controls unexposed, sick) 2011	Uganda 2003 - 2005 randomized controlled trial	A randomised, double-blind, placebo-controlled trial at Entebbe Hospital.	Pregnant women receiving a single dose of oral albendazole (400 mg) and placebo.	unexposed, sick Pregnant women receiving placebo and placebo.	2nd and/or 3rd trimester	625 / 628	(Ndibazza 2010 ; Webb 2011 and Mpairwe 2011 => same placebo-controlled, with different outcomes, except for Stillbirths (overlapping) for which the data provided by Ndibazza 2010 was reported (rather than Mpairwe 2011) because these data were adjusted.
Mpairwe (Controls unexposed, sick) 2011	Uganda 2003 - 2005 randomized controlled trial		Pregnant women were allocated to one of the four treatment arms according to a random sequence. Participants and staff were blinded to treatment allocation.		2nd and/or 3rd trimester	625 / 628
Ndibazza (Controls exposed to praziquantel) 2010	Uganda 2003 - 2005 randomized controlled trial	A large placebo-controlled trial conducted at the Entebbe Hospital.	Pregnant women receiving oral albendazole (400 mg) and placebo in their second or third trimester.	exposed to other treatment, sick Pregnant women receiving praziquantel and placebo in their second or third trimester.	2nd and/or 3rd trimester	625 / 626	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.
Ndibazza (Controls exposed to praziquantel) 2010	Uganda 2003 - 2005 randomized controlled trial		Participants were randomized and double-blind assigned to receive albendazole.		2nd and/or 3rd trimester	625 / 626
Ndibazza (Controls unexposed, sick) 2010	Uganda 2003 - 2005 randomized controlled trial	A large placebo-controlled trial conducted at the Entebbe Hospital.	Pregnant women receiving oral albendazole (400 mg) and placebo in their second or third trimester.	unexposed, sick Pregnant women receiving placebo and placebo in their second or third trimester.	2nd and/or 3rd trimester	625 / 628	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.
Ndibazza (Controls unexposed, sick) 2010	Uganda 2003 - 2005 randomized controlled trial		Participants were randomized and double-blind assigned to receive albendazole.		2nd and/or 3rd trimester	625 / 628
Ndyomugyenyi (Controls exposed to ivermectin) 2008	Uganda 2003 - 2005 randomized controlled trial	A randomized, open label, controlled trial in Masindi district in western Uganda.	Women infected with any intestinal helminth receiving albendazole administered as a single dose of 400 mg.	exposed to other treatment, sick Women infected with any intestinal helminth receiving ivermectin administered according to height.	2nd trimester	160 / 170	Ndibazza 2010 and Ndyomugyenyi 2008: 2 clinical trials not conducted in the same districts: Entebbe municipality and Masindi district=> different data.
Ndyomugyenyi (Controls exposed to ivermectin) 2008	Uganda 2003 - 2005 randomized controlled trial		Women were randomly assigned to receive albendazole administered as a single dose of 400 mg or ivermectin or a combination of both. The drugs were taken under direct supervision.		2nd trimester	160 / 170
Ndyomugyenyi (Controls unexposed, disease free) 2008	Uganda 2003 - 2005 randomized controlled trial	A randomized, open label, controlled trial in Masindi district in western Uganda.	Women infected with any intestinal helminth receiving albendazole administered as a single dose of 400 mg.	unexposed, disease free Pregnant women without soil-transmitted helminths (STHs).	2nd trimester	160 / 207	Ndibazza 2010 and Ndyomugyenyi 2008: 2 clinical trials not conducted in the same districts: Entebbe municipality and Masindi district=> different data.
Ndyomugyenyi (Controls unexposed, disease free) 2008	Uganda 2003 - 2005 randomized controlled trial		Women were randomly assigned to receive albendazole administered as a single dose of 400 mg or ivermectin or a combination of both. The drugs were taken under direct supervision.		2nd trimester	160 / 207

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

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

Empty. There are no case-control studies available for this drug.

master protocol