• 2
    Jan
  • Prospective, controlled, multicentre study of loperamide in pregnancy: RESULTS

A total of 105 women from five centres were followed pro- spectively. There were 58 cases from Toronto, Ontario; 25 from Rome, Italy; 16 from Jerusalem, Israel; four from Milan, Italy; and two from Helsinki, Finland. Eighty-nine (85%) women took loperamide during organogenesis, with 21 (20%) taking it throughout their pregnancies. Indications for use were short term, for an acute case of diarrhea, or chronic, for bowel disease such as Crohn’s disease or irritable bowel syndrome. The doses varied greatly, from 4 to 6 mg in total, to 2 to 6 mg/day throughout the pregnancy.

In the study group, there were 95 live births, four thera­peutic abortions and six spontaneous abortions. There were no major malformations and three minor malformations re­ported. The malformations consisted of a heart murmur, a mild right pelviectasis (no symptoms) and a hypospadia (mi­nor). The mean birth weight was 3368 g (Table 1).

A subanalysis comparing the women who took the drug throughout pregnancy for chronic bowel disease with the women who took only a few doses for acute diarrhea was per­formed; the mean birth weight was 3261 g among women who took the drug throughout their pregnancy compared with 3441 g in those who took the drug for acute diarrhea. However, this difference was not statistically significant, al­though in the chronic use group, half of the babies weighed less than 3000 g (11 of 21). There were no statistical differ­ences in the preterm delivery rates between the acute users and chronic users – four of 74 (5%) and two of 21(9%) babies, respectively, were born before 36 weeks’ gestation (Ta­ble 2).

TABLE 1 Pregnancy outcome

Outcome

Case

Control

P

Live births

95/105

94/105

0.5

Spontaneous abortions

6/105

9/105

0.59

Therapeutic abortions

4/105

2/105

0.68

Major malformations

0/95

1/94

0.49

Minor malformations

3/95

3/94

0.62

Birth weight, g (mean ± SD)

3368±533

3407±470

0.68

In the control group, there were 94 live births, two thera­peutic abortions and nine spontaneous abortions. There was a baby with Down’s syndrome and one major malformation: cleft palate with cupped ears. There were three minor mal­formations: bilateral twisted feet (no surgery required), microfacelia and pulmonary stenosis. The mean birth weight was 3407 g. Comparison between the two groups (Table 2) found no statistical differences in pregnancy outcome, in­cluding spontaneous and therapeutic abortions, rates of ma­jor and minor malformations, and mean birth weights. Maternal characteristics were also compared among the study group, the control group and the group lost to fol­low-up; no differences were found.
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TABLE 2 Comparison of birth outcomes between chronic and acute users of loperamide

Acute use

Chronic use

(n = 74)

(n=21)

P

Preterm labour

4

2

0.86

Birth weight, g (mean ± SD)

3441±544

3261 ±693

0.21

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