A comparison of efficacy, safety, and adherence profiles of bowel regimens in pregnancy-related constipation

Introduction: Constipation is a common complaint in 40% of all pregnant women but data on bowel regimens used in this population is very limited. Objectives: The purpose of this study was to determine efficacy, safety, and adherence profiles of commonly prescribed bowel regimens in pregnancy-related constipation. Study Design: This study was a prospective, single-centered, clinical trial. Methods: Eligible subjects included pregnant women of all trimesters who were diagnosed with constipation and were prescribed lactulose or docusate. Excluded subjects included pregnant women greater than 18 years old and those who do not speak English. The primary endpoint was the difference in the total Patient Assessment of Constipation Symptoms (PAC-SYM) score between docusate and lactulose after two weeks of therapy. Secondary endpoints included the differences between the rectal symptoms, stool symptoms, and abdominal symptoms of the PAC-SYM questionnaire and adherence profiles using the Medication Adherence Questionnaire (Morisky 4). The Mann-Whitney U Test was used to calculate nonparametric data. P-values were 2-sided at a 95% confidence interval. Results: Of the 89 subjects were assessed, 50 were initiated on docusate and 39 were started on lactulose. Overall, there were no differences for the total PAC-SYM questionnaire scores between docusate and lactulose (2 ± 0.73 vs. 3 ± 1.24 respectively; P-value = 0.07). While there were also no difference between stool and abdominal symptoms (P = 0.25 and P = 0.13 respectively), those taking docusate had less rectal symptoms on the PAC-SYM (0 ± 0.20 vs. 1 ± 0.28; P = 0.04). Adherence and side effect profiles were not different between the two laxatives (P > 0.05). Conclusions: Overall, the safety, efficacy, and adherence profile between docusate and lactulose were similar. Pregnant women with constipation may use either therapy for constipation, although those using docusate may have less rectal symptoms from constipation.