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Pregnancy outcome after first trimester exposure to domperidone—An observational cohort study

Journal Article · · Journal of Obstetrics and Gynaecology Research
DOI:https://doi.org/10.1111/jog.14709· OSTI ID:1767368
 [1];  [1];  [2];  [2];  [3];  [4];  [5];  [6];  [7];  [1]
  1. Department of Pharmacy Toranomon Hospital Minato‐ku Tokyo Japan
  2. Department of Obstetrics and Gynecology Toranomon Hospital Minato‐ku Tokyo Japan
  3. Department of Biostatistics, M&,D Data Science Center Tokyo Medical and Dental University Bunkyo‐ku Tokyo Japan
  4. The Japan Drug Information Institute in Pregnancy National Center for Child Health and Development Setagaya‐ku Tokyo Japan
  5. Human Health Sciences Kyoto University Graduate School of Medicine Sakyo‐ku Tokyo Japan
  6. Department of Pharmacy Yokohama Minami Kyousai Hospital Yokohama Kanagawa Japan
  7. Center of Maternal‐Fetal, Neonatal and Reproductive Medicine National Center for Child Health and Development Setagaya‐ku Tokyo Japan
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Abstract Aim

To assess the teratogenic risk of domperidone by comparing the incidence of major malformation with domperidone to a control.

Methods

Pregnancy outcome data were obtained for women at two Japanese facilities that provide counseling on drug use during pregnancy between April 1988 and December 2017. The incidence of major malformation was calculated among infants born to women taking domperidone ( n = 519), nonteratogenic drugs (control, n = 1673), or metoclopramide (reference, n = 241) during the first trimester of pregnancy. Using the control group as reference, the crude odds ratio (OR) of the incidence of major malformation in the domperidone and metoclopramide groups was calculated using univariable logistic regression analysis. Adjusted OR was also calculated using multivariable logistic regression analysis adjusted for various other factors.

Results

The incidence of major malformation was 2.9% (14/485, 95% confidence interval [CI]: 1.6–4.8) in the domperidone group, 1.7% (27/1554, 95%CI: 1.1–2.5) in the control group, and 3.6% (8/224, 95%CI: 1.6–6.9) in the metoclopramide group. The adjusted multivariable logistic regression analysis showed no significant difference in incidence between the control and domperidone groups (adjusted OR: 1.86 [95%CI: 0.73–4.70], p = 0.191) or between the control and metoclopramide groups (adjusted OR: 2.20 [95%CI: 0.69–6.98], p = 0.183).

Conclusions

This observational cohort study showed that domperidone exposure during the first trimester was not associated with increased risk of major malformation in infants. These results may help alleviate the anxiety of patients who took domperidone during pregnancy.

Sponsoring Organization:
USDOE
OSTI ID:
1767368
Alternate ID(s):
OSTI ID: 1786884
Journal Information:
Journal of Obstetrics and Gynaecology Research, Journal Name: Journal of Obstetrics and Gynaecology Research Journal Issue: 5 Vol. 47; ISSN 1341-8076
Publisher:
Wiley-BlackwellCopyright Statement
Country of Publication:
Country unknown/Code not available
Language:
English

References (6)

Metoclopramide in Pregnancy and Risk of Major Congenital Malformations and Fetal Death journal October 2013
First trimester exposure to domperidone: A comparative prospective study of exposed infants journal November 2015
The Safety of Metoclopramide Use in the First Trimester of Pregnancy journal June 2009
Atypical Antipsychotic Drugs and Pregnancy Outcome: A Prospective, Cohort Study journal January 2013
The French Pregnancy Cohort: Medication use during pregnancy in the French population journal July 2019
Fetal and neonatal outcomes in women taking domperidone during pregnancy journal February 2013

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