| 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 |
|---|---|---|---|---|---|---|---|---|
|
Ashkenazi-Hoffnung 2013 |
Israël 2008 - 2010 prospective cohort |
Beilinson Teratology Information Service (BELTIS), a free call-in center for queries regarding drug use during pregnancy and lactation, Israel. | Pregnant women treated with metoclopramide only (control group in the original publication). |
exposed to other treatment, sick
Pregnant women treated with the combination of pyridoxine and doxylamine only (treatment group in the original publication). |
at least 1st trimester | 29 / 29 | In the original study: Metoclopramide: control group. For the Meta-analysis, results were provided with Metoclopramide as the exposed group. | |
| At the initial phone conversation, information was obtained using a standard questionnaire and included use of medications. | ||||||||
|
Asker 2005 |
Sweden 1995 - 2002 population based cohort retrospective |
The Swedish Medical Birth Registry, the Registry of Congenital Malformations, and the Hospital Discharge Register. | All women who reported use of metoclopramide during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
All women who had given birth during the study period. |
during pregnancy (anytime or not specified) | 1166 / 665572 | During this time, 29,804 pregnant women with 31,130 infants reported the use of antiemetic drugs from a total of 665,572 pregnant women with 676,198 infants that were registered. | |
| The standard practice in Sweden is that during the first antenatal care visit (usually between weeks 10 and 12), the pregnant woman is interviewed by a midwife. Among the many questions asked is one which refers to drug use since the woman has become pregnant. | ||||||||
|
Bérard 2019 |
Canada 1998 - 2015 population based cohort propective |
The Quebec Pregnancy Cohort (QPC). | Exposure was defined as having filled at least one prescription for metoclopramide within the first trimester of pregnancy. |
unexposed (general population or NOS)
Pregnancies without prescription for antiemetic (doxylamine-pyridoxine, metoclopramide, or ondansetron) within the first trimester of pregnancy. |
1st trimester | 958 / 179106 | EXPOSURE: 45,623 pregnancies exposed to doxylamine-pyridoxine; 958 to metoclopramide; 31 to ondansetron. TOTAL: 45770. | |
| The Quebec Prescription Drug Insurance Plan administered by the Régie de l’assurance maladie du Quebec (RAMQ). | ||||||||
|
Berkovitch 2002 |
Israel, Italy, Brazil and Canada Not specified prospective cohort |
6 Teratology Information Service (TIS) | Pregnant women who were counseled because they had taken metoclopramide during the first trimester of pregnancy for nausea and vomiting. |
unexposed, disease free
Pregnant women who were counseled at the participating centers during the study period for the use of drugs that are known to be nonteratogenic and nonembryotoxic. |
1st trimester, during pregnancy (anytime or not specified) | 175 / 175 | This study included Berkovitch et al. 2000. For major malformation, organogenesis was defined as the period between the 4th and 13th week of gestation. Acquisition of milestones defined as age at which competence was acquired of milestone. | |
| Data were collected at the time of exposure and before pregnancy outcome was known. | ||||||||
|
Bsat 2003 |
USA 1994 - 1996 randomized controlled trial |
Not specified | The patients in Group A received one 50 mg intramuscular injection of pyridoxine, with metoclopramide 10 mg orally every 6 hours as needed. |
exposed to other treatment, sick
The patients in Group C received promethazine 25 mg orally every 6 hours as needed. |
1st trimester | 54 / 52 | ||
| Patients were prospectively randomized into three treatment groups: pyridoxine–metoclopramide, prochlorperazine, or promethazine. Mean gestational age between 7.9 and 8.6 weeks (according regimens). | ||||||||
|
Bylsma-Howell 1983 |
Canada Not specified randomized controlled trial |
Double-blind study in parturient women undergoing elective Caesarian section. | Pregnant women administered metoclopramide intravenously approximatively 30 preoperatlively. |
unexposed, sick
Pregnant women administered a normal saline placebo intravenously approximatively 30 preoperatlively. |
late pregnancy | 8 / 12 | ||
| Administration in a double-blind way of metoclopramide or placebo in parturient women undergoing elective Caesarian section. | ||||||||
|
Howard 1973 |
United Kingdom Not specified randomized controlled trial |
Not specified | Intramuscular injection of metoclopramide 10 mg. |
unexposed, sick
Intramuscular injection of placebo (sterile water). |
late pregnancy | 13 / 12 | 'Metoclopramide had no detectable adverse effects on the patients, the fetuses, or the progress of labour.' | |
| The subjects were given either metoclopramide 10 mg or sterile water by intramuscular injection on a double-blind random basis at the start of the test, in each case once labour had definitely become established. | ||||||||
|
Huybrechts 2018 |
USA 2000 - 2013 retrospective cohort (claims database) |
Medicaid Analytic eXtract (MAX) | Women who filled at least 1 metoclopramide prescription during the first 3 months of pregnancy. |
exposed to other treatment, sick
Women who filled at least 1 ondansetron prescription during the first 3 months of pregnancy. |
1st trimester | 52818 / 88467 | Originally, the authors studied Ondansetron versus Metoclopramide. Exposure groups were reversed for this meta-analysis. | |
| Prescriptions filled on an outpatient basis. | ||||||||
|
Kafle 1993 |
Nepal Not specified randomized controlled trial |
Not specified | Pregnant women received intrathecal 5% meperidine 1 mg/kg and metoclopramide iv 10 mg one hour before surgery (premedication with oral ranitidine also given). |
exposed to other treatment, sick
Pregnant women received 5% heavy lidocaine 1.2-1.4 ml (premedication with oral ranitidine also given). |
late pregnancy | 25 / 25 | All newborns in both groups cried immediately after birth. Apgar score was >7 in all at birth and at five minutes. No baby was reported to have problems later on and at the time of discharge. | |
| Patients randomly divided into two groups to receive either intrathecal meperidine (and metoclopramide and ranitidine) or lidocaine (and ranitidine). | ||||||||
|
Lussos 1992 |
USA Not specified randomized controlled trial |
A double-blind randomized trial. | Parturients received 2 ml (10 mg) metoclopramide intraveinously pre-cesarean. |
unexposed, sick
Parturients received 2 ml normal saline intraveinously pre-cesarean. |
late pregnancy | 21 / 21 | There were no significant differences in umbilical vein or arterial blood gas values and in neurobehavioral: the 2 groups scored similarly in evaluations of wakefulness, muscle tone, reflex responses ans responses to light, sound ans limb flexion. | |
| Parturients were randomized in a double-blind fashion to receive either 2 ml (10 mg) metoclopramide, or 2 ml normal saline intraveinously. | ||||||||
|
Matok 2009 |
Israël 1998 - 2007 retrospective cohort (claims database) |
Three databases: two from Soroka Medical Center and one from Clalit Health Services (the largest health maintenance organization in Israel, which insures 70% of the population 15 to 49 years of age in the Beer-Sheva district in southern Israel). | The exposed group comprised the infants of women to whom metoclopramide (ATC code A03FA01) was dispensed during the first trimester of pregnancy (at 13 weeks’ gestation or earlier). |
unexposed (general population or NOS)
The unexposed group comprised the infants of all women who did not take metoclopramide during the first trimester over the course of the study period. |
1st trimester | 3458 / 78245 | There was no significant dose–response effect in the association between metoclopramide and the risk of major congenital malformations. | |
| The three databases — one from Clalit Health Services and two from Soroka Medical Center — were encoded and linked to create a registry of medications dispensed during pregnancy. | ||||||||
|
McGarry (Control exposed to perphenazine) 1971 |
United Kingdom Not specified randomized controlled trial |
A double- blind trial in normal labour. | Women analgesied with Pethidine 100 mg was given by intramuscular injection, together with metoclopramide 10 mg. |
exposed to other treatment, sick
Women analgesied with Pethidine 100 mg was given by intramuscular injection, together with perphenazine 5 mg. |
late pregnancy | 196 / 197 | The Apgar score of the babies was also the same. | |
| Patients were allocated to one of the three regimes in accordance with random sequence tables. When analgesia became necessary, pethidine 100 mg was given by intramuscular injection, together with either metoclopramide 10 mg or perphenazine 5 mg, or normal saline 2 ml by the same route. | ||||||||
|
McGarry (Unexposed control) 1971 |
United Kingdom Not specified randomized controlled trial |
A double- blind trial in normal labour. | Women analgesied with Pethidine 100 mg was given by intramuscular injection, together with metoclopramide 10 mg. |
unexposed, sick
Women analgesied with Pethidine 100 mg was given by intramuscular injection, together with normal saline 2 ml. |
late pregnancy | 196 / 191 | The Apgar score of the babies was also the same. | |
| Patients were allocated to one of the three regimes in accordance with random sequence tables. When analgesia became necessary, pethidine 100 mg was given by intramuscular injection, together with either metoclopramide 10 mg or perphenazine 5 mg, or normal saline 2 ml by the same route. | ||||||||
|
Neri 2005 |
Italy 2001 - 2002 randomized controlled trial |
Department of Obstetrics and Gynecology of the Universities of Modena-Reggio Emilia and Turin | Pregnant women receiving metoclopramide infusion (metoclopramide group) supplemented by vitamin B12 complex. |
unexposed, sick
Pregnant women receiving acupuncture sessions plus acupressure (acupunture group). |
1st trimester | 38 / 43 | As far as the fetal outcome was concerned no differences were observed between ACU and MCP groups for age at delivery (39.2±1.7 vs 40.2±1.1 weeks), birth-weight (3 123±329 vs 3 425±450) and rate of cesarean section (10% vs 15%). | |
| Randomisation by computer. In the metoclopramide group, the patients received metoclopramide infusion (20 mg/500 mL saline for 60 min) at hospital, twice a week for 2 weeks. Oral supplementation with vitamin B12 complex (pyridoxine, hydroxycobalamine) (30 mg/day) prescribed at home. | ||||||||
|
Orr 1993 |
Not specified Not specified randomized controlled trial |
Groups 3 and 4 received omeprazole treatments (as groups 1 and 2 respectively), but in addition were given metoclopramide 10 mg intramuscularly at least 20 min before induction of anaesthesia. |
unexposed, sick
Groups 1 and 2 received omeprazole treatments only according 2 dose regimens: 40mg at 20.00 h on the evening before surgery and at 06.00 h on the morning of surgery (group 1); omeprazole 80 mg at 06.00 h (group 2). |
late pregnancy | 31 / 63 | Apgar and Neurobehavioural and adaptive capacity scoring system (NACS) scores of the infants did not show significant intergroup variation (Table 4). | ||
| Exposed pregnant women were given metoclopramide 10 mg intramuscularly at least 20 min before induction of anaesthesia. | ||||||||
|
Pasternak 2013 |
Denmark 1997 - 2011 population based cohort retrospective |
National register-based cohort. | Pregnant women with dispensation of metoclopramide throughout the respective exposure time window, with exclusion of women diagnosed with cancer within 6 months prior to pregnancy onset. |
unexposed (general population or NOS)
Unexposed women were those who did not use metoclopramide throughout the respective exposure time window. Women who had filled metoclopramide prescriptions within 1 month before pregnancy onset were excluded. |
1st trimester, during pregnancy (anytime or not specified), early pregnancy, throughout pregnancy | 45002 / 1177501 | Analyses of fetal death outcomes were based on all pregnancies in the cohort, whereas analyses of malformations, preterm birth, low birth weight, and SGA were based on live births. | |
| Prescriptions for metoclopramide dispensed to women in the cohort identified from the National Prescription Registry, with the timing of exposure defined by the prescription fill date. | ||||||||
|
Shahriari 2009 |
Iran Not specified randomized controlled trial |
A double-blind study, in Hospital of Tehran, Iran. | Pregnant women injected metoclopramide 10 mg at the beginning of surgery before skin incision. |
exposed to other treatment, sick
Pregnant women injected midazolam 2 mg at the beginning of surgery before skin incision. |
late pregnancy | 40 / 40 | ||
| Pregnant women were allocated randomly to receive midazolam 2 mg, or metoclopramide 10 mg at the beginning of surgery before skin incision. | ||||||||
|
Sorensen 2000 |
Denmark 1991 - 1996 retrospective cohort (claims database) |
Pharmaco-Epidemiological Prescription Database of North Jutland County and Danish Medical Birth Registry | Women who had a singleton pregnancy in which they had taken up a prescription for metoclopramide. |
unexposed (general population or NOS)
Pregnant mothers who had obtained no prescriptions for any reimbursed drugs in any of the referenced time windows. |
1st trimester, 2nd and/or 3rd trimester, during pregnancy (anytime or not specified) | 309 / 13327 | Risk of Malformations: Interval 1: 0±30 days before conception to the end of 12th gestational week. Risk of pretem and low birth weight: Interval 2: Second and third trimester | |
| Pharmaco-Epidemiological Prescription Database of North Jutland which thus retains key information on all prescribed and reimbursed drugs sold at pharmacies in the county | ||||||||
| Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
|---|---|---|---|---|---|---|---|---|---|
|
Anderka 2012 |
USA 1997 - 2004 case control |
The National Birth Defects Prevention Study (NBDPS). | All infants with any of more than 30 selected birth defects. | Controls without birth defects. | Histories of NVP and treatments obtained from a standardized computer- assisted telephone interview with the mother. Data were collected by month for the first trimester and by trimester for the second and third trimesters. | 1st trimester | 4524 / 5859 | ||
| Case infants (over 30 different birth defects) are identified prenatally, at birth or during the first year of life from surveillance systems (10 participating states). 9 sites also collected fetal deaths at 20 GW or greater and 8 sites collected diagnosed and electively terminated. | |||||||||
|
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 surveyregarding 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). | |
| 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. | |||||||||
|
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). | |
| 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. | |||||||||
|
Lind 2013 |
USA 1997 - 2007 case control |
National Birth Defects Prevention Study (NBDPS) | Male infants with isolated second- or third-degree hypospadias, defined as the urethral opening at the penile shaft, scrotum, or perineum. | Male infants with no major birth defects selected randomly from vital records or birth logs. | The National Birth Defects Prevention Study uses computer-assisted telephone interviews to collect information from women 6 weeks to 24 months after their estimated date of delivery. | 1st trimester | 1537 / 4314 | National Birth Defects Prevention Study excludes first-degree hypospadias. Arkansas, California, Georgia, Iowa, and Texas also include pregnancies that are diagnosed prenatally. | |
| Cases are identified through population-based birth defects surveillance from each states. A clinical geneticist classifies eligible cases of hypospadias as isolated. | |||||||||
|
Zarante 2009 |
Colombia 2001- 2006 case control |
Several Colombian hospitals participating in the ECLAMC (Spanish acronym for Latin-American Collaborative Study of Congenital Malformations) program. | All newborns and stillborns of weight >500 g that presented only one craniofacial malformation, not associated with any other congenital condition. | The next non-malformed same sex child born in the same hospital. | Information collected in 10 Colombian hospitals (NOS). | during pregnancy (anytime or not specified) | 374 / 728 | ||
| Information collected in 10 Colombian hospitals (NOS). | |||||||||
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;
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