Metoclopramide - Medication and Pregnancy KB

Metoclopramide

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Ashkenazi-Hoffnung, 2013	Israël 2008 - 2010	All women who contacted the Beilinson Teratology Information Service (BELTIS) regarding treatment of nausea and vomiting of pregnancy (NVP) were eligible for inclusion.	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).	29 / 29	In the original study: Metoclopramide: control group. For the Meta-analysis, results were provided with Metoclopramide as the exposed group.
Asker, 2005	Sweden 1995 - 2002	Nearly all deliveries in Sweden (a few percentages are missing), including liveborn infants and stillbirths (according to the Swedish definition, 28 completed gestational weeks).	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.	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.
Bérard, 2019	Canada 1998 - 2015	All pregnancies covered by the Quebec Prescription Drug Insurance Plan administered by the Régie de l’assurance maladie du Quebec (RAMQ).	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.	958 / 179106	EXPOSURE: 45,623 pregnancies exposed to doxylamine-pyridoxine; 958 to metoclopramide; 31 to ondansetron. TOTAL: 45770.
Berkovitch, 2002	Israel, Italy, Brazil and Canada Not specified	Pregnant women who called 1 of 6 teratogen information services to obtain information about exposure during pregnancy.	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.	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.
Bsat, 2003	USA 1994 - 1996	Patients with singleton gestations presenting in the first trimester to their obstetrical provider with nausea and/or vomiting.	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.	54 / 52
Bylsma-Howell, 1983	Canada Not specified	Patients undergoing general anaesthesia for Caesarian section for healthy term pregnancies (without evidence of foetal distress)	Pregnant women administered metoclopramide intravenously approximatively 30 preoperatlively.	unexposed, sick Pregnant women administered a normal saline placebo intravenously approximatively 30 preoperatlively.	8 / 12
Howard, 1973	United Kingdom Not specified	Patients primigravidae who had volunteered during the antenatal period.	Intramuscular injection of metoclopramide 10 mg.	unexposed, sick Intramuscular injection of placebo (sterile water).	13 / 12	'Metoclopramide had no detectable adverse effects on the patients, the fetuses, or the progress of labour.'
Huybrechts, 2018	USA 2000 - 2013	Women aged 12 through 55 years were required to have Medicaid coverage from 3 months before the date of the last menstrual period to 1 month after delivery	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.	52818 / 88467	Originally, the authors studied Ondansetron versus Metoclopramide. Exposure groups were reversed for this meta-analysis.
Kafle, 1993	Nepal Not specified	Full-term pregnant women of ASA status I or II, presenting for elective Caesarean section	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).	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.
Lussos, 1992	USA Not specified	Parturients scheduled for elective cesarean delivery during spinal anasthesia.	Parturients received 2 ml (10 mg) metoclopramide intraveinously pre-cesarean.	unexposed, sick Parturients received 2 ml normal saline intraveinously pre-cesarean.	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.
Matok, 2009	Israël 1998 - 2007	All girls and women 15 to 49 years of age who were registered in Clalit Health Services and were living in the Beer-Sheva district and who had a singleton delivery at Soroka Medical Center were included in the analyses.	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.	3458 / 78245	There was no significant dose–response effect in the association between metoclopramide and the risk of major congenital malformations.
McGarry (Control exposed to perphenazine), 1971	United Kingdom Not specified	Pregnant women expected to have a vaginal delivery were studied during 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.	196 / 197	The Apgar score of the babies was also the same.
McGarry (Unexposed control), 1971	United Kingdom Not specified	Pregnant women expected to have a vaginal delivery were studied during 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.	196 / 191	The Apgar score of the babies was also the same.
Neri, 2005	Italy 2001 - 2002	Patients affected by Hyperemesis gravidarum (HG), referred to the Universities and with singleton and gestation age lower than 12th weeks	Pregnant women receiving metoclopramide infusion (metoclopramide group) supplemented by vitamin B12 complex.	unexposed, sick Pregnant women receiving acupuncture sessions plus acupressure (acupunture group).	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%).
Orr, 1993	Not specified Not specified	Healthy women with an uncomplicated pregnancy of at least 36weeks gestation, to be delivered by elective Caesarean section under general anaesthesia between 08.00 h and 12.00 noon, were included in the study	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).	31 / 63	Apgar and Neurobehavioural and adaptive capacity scoring system (NACS) scores of the infants did not show significant intergroup variation (Table 4).
Pasternak, 2013	Denmark 1997 - 2011	All pregnancies in Denmark with delivery dates (all singleton live births and stillbirths) or dates of abortive outcome during the study period.	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.	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.
Shahriari, 2009	Iran Not specified	Full term women weighting between 50 and 75 Kg, classified as ASAI, between the ages 18 to 38 years, scheduled for elective caesarean section under spinal anaesthesia.	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.	40 / 40
Sorensen, 2000	Denmark 1991 - 1996	All women delivering a child (approximately 36 000 births) in the county (constituting 9% of the total Danish population).	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.	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

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk
Anderka, 2012	USA 1997 - 2004	All infants with any of more than 30 selected birth defects.	Controls without birth defects.	4524 / 5859
Fejzo, 2013	USA 2007 - 2011	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.	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, 2015	USA 2007 - 2011	Children exposed to hyperemesis gravidarum (HG) with neurodevelopmental delay.	Children exposed to hyperemesis gravidarum (HG) with a good outcome.	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).
Lind, 2013	USA 1997 - 2007	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.	1537 / 4314	National Birth Defects Prevention Study excludes first-degree hypospadias. Arkansas, California, Georgia, Iowa, and Texas also include pregnancies that are diagnosed prenatally.
Zarante, 2009	Colombia 2001- 2006	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.	374 / 728

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