Polyethylene glycol compared to lactulose for constipation in pregnancy: A randomized controlled trial

Objective: To compare polyethylene glycol 4000 versus lactulose in chronic constipation during pregnancy. Methods: Women at 28-32 weeks' gestation attending antenatal clinic for routine care were screened using the Rome IV chronic constipation criterion. Eligible women were approached and conse...

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Main Authors: Raj, Victoria Ivy, Hassan, Azyyati, Hanafiah, Nurulashikin, Azhary, Jerilee Mariam Khong, Lim, Boon Kiong, Saaid, Rahmah, Gan, Farah, Tan, Peng Chiong
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Published: Elsevier 2024
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Online Access:http://eprints.um.edu.my/47043/
https://doi.org/10.1002/ijgo.15431
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spelling my.um.eprints.470432025-01-06T04:26:39Z http://eprints.um.edu.my/47043/ Polyethylene glycol compared to lactulose for constipation in pregnancy: A randomized controlled trial Raj, Victoria Ivy Hassan, Azyyati Hanafiah, Nurulashikin Azhary, Jerilee Mariam Khong Lim, Boon Kiong Saaid, Rahmah Gan, Farah Tan, Peng Chiong RG Gynecology and obstetrics Objective: To compare polyethylene glycol 4000 versus lactulose in chronic constipation during pregnancy. Methods: Women at 28-32 weeks' gestation attending antenatal clinic for routine care were screened using the Rome IV chronic constipation criterion. Eligible women were approached and consented. Participants were randomized to oral polyethylene glycol (10 g/day) or lactulose (10 g/day) for 4 weeks. A bowel movement diary was kept and outcomes using the Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM), Patient Assessment of Constipation Quality of Life questionnaire (PAC-QoL) and Bristol Stool Form Scale (BSFS), which were evaluated at the start and end of the four-week period. Relative risks (RR) were determined for the coprimary outcomes of complete spontaneous bowel movement (CSBM) and PAC-SYM mean score improvement (decrease in score of >1 from the baseline). Results: A total of 4323 women underwent screening, of which 780 fulfilled the Rome IV criterion, and 360 consented to participate (180 randomized to PEG and lactulose, respectively). Data from 247 women who completed the study were analyzed. CSBM was achieved in 107/124 (86.3%) versus 102/123 (82.9%) (RR 1.04, 95% CI: 0.93-1.16, P = 0.464) for PEG and lactulose trial arms, respectively. PAC-SYM mean score improvement was 62/118 (52.5%) in the PEG arm versus 44/118 (37.3%) in the lactulose arm (RR 1.40, 95% CI: 1.05-1.88). Of secondary outcomes, a significant difference was found in favor of PEG, with respect to PAC-SYM abdominal symptoms subscale, normal stool versus loose stool consistency and side effects of vomiting and diarrhea. After controlling for parity, baseline PAC-SYM, PAC-QoL scores, characteristics different at baseline, only diarrhea and loose stools remained significant. Conclusion: Both PEG 4000 and lactulose are effective laxatives in pregnancy with similar performance after adjusted analysis. Diarrhea and loose stools are less frequently reported with PEG. Elsevier 2024-08 Article PeerReviewed Raj, Victoria Ivy and Hassan, Azyyati and Hanafiah, Nurulashikin and Azhary, Jerilee Mariam Khong and Lim, Boon Kiong and Saaid, Rahmah and Gan, Farah and Tan, Peng Chiong (2024) Polyethylene glycol compared to lactulose for constipation in pregnancy: A randomized controlled trial. International Journal of Gynecology & Obstetrics, 166 (2). pp. 828-836. ISSN 0020-7292, DOI https://doi.org/10.1002/ijgo.15431 <https://doi.org/10.1002/ijgo.15431>. https://doi.org/10.1002/ijgo.15431 10.1002/ijgo.15431
institution Universiti Malaya
building UM Library
collection Institutional Repository
continent Asia
country Malaysia
content_provider Universiti Malaya
content_source UM Research Repository
url_provider http://eprints.um.edu.my/
topic RG Gynecology and obstetrics
spellingShingle RG Gynecology and obstetrics
Raj, Victoria Ivy
Hassan, Azyyati
Hanafiah, Nurulashikin
Azhary, Jerilee Mariam Khong
Lim, Boon Kiong
Saaid, Rahmah
Gan, Farah
Tan, Peng Chiong
Polyethylene glycol compared to lactulose for constipation in pregnancy: A randomized controlled trial
description Objective: To compare polyethylene glycol 4000 versus lactulose in chronic constipation during pregnancy. Methods: Women at 28-32 weeks' gestation attending antenatal clinic for routine care were screened using the Rome IV chronic constipation criterion. Eligible women were approached and consented. Participants were randomized to oral polyethylene glycol (10 g/day) or lactulose (10 g/day) for 4 weeks. A bowel movement diary was kept and outcomes using the Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM), Patient Assessment of Constipation Quality of Life questionnaire (PAC-QoL) and Bristol Stool Form Scale (BSFS), which were evaluated at the start and end of the four-week period. Relative risks (RR) were determined for the coprimary outcomes of complete spontaneous bowel movement (CSBM) and PAC-SYM mean score improvement (decrease in score of >1 from the baseline). Results: A total of 4323 women underwent screening, of which 780 fulfilled the Rome IV criterion, and 360 consented to participate (180 randomized to PEG and lactulose, respectively). Data from 247 women who completed the study were analyzed. CSBM was achieved in 107/124 (86.3%) versus 102/123 (82.9%) (RR 1.04, 95% CI: 0.93-1.16, P = 0.464) for PEG and lactulose trial arms, respectively. PAC-SYM mean score improvement was 62/118 (52.5%) in the PEG arm versus 44/118 (37.3%) in the lactulose arm (RR 1.40, 95% CI: 1.05-1.88). Of secondary outcomes, a significant difference was found in favor of PEG, with respect to PAC-SYM abdominal symptoms subscale, normal stool versus loose stool consistency and side effects of vomiting and diarrhea. After controlling for parity, baseline PAC-SYM, PAC-QoL scores, characteristics different at baseline, only diarrhea and loose stools remained significant. Conclusion: Both PEG 4000 and lactulose are effective laxatives in pregnancy with similar performance after adjusted analysis. Diarrhea and loose stools are less frequently reported with PEG.
format Article
author Raj, Victoria Ivy
Hassan, Azyyati
Hanafiah, Nurulashikin
Azhary, Jerilee Mariam Khong
Lim, Boon Kiong
Saaid, Rahmah
Gan, Farah
Tan, Peng Chiong
author_facet Raj, Victoria Ivy
Hassan, Azyyati
Hanafiah, Nurulashikin
Azhary, Jerilee Mariam Khong
Lim, Boon Kiong
Saaid, Rahmah
Gan, Farah
Tan, Peng Chiong
author_sort Raj, Victoria Ivy
title Polyethylene glycol compared to lactulose for constipation in pregnancy: A randomized controlled trial
title_short Polyethylene glycol compared to lactulose for constipation in pregnancy: A randomized controlled trial
title_full Polyethylene glycol compared to lactulose for constipation in pregnancy: A randomized controlled trial
title_fullStr Polyethylene glycol compared to lactulose for constipation in pregnancy: A randomized controlled trial
title_full_unstemmed Polyethylene glycol compared to lactulose for constipation in pregnancy: A randomized controlled trial
title_sort polyethylene glycol compared to lactulose for constipation in pregnancy: a randomized controlled trial
publisher Elsevier
publishDate 2024
url http://eprints.um.edu.my/47043/
https://doi.org/10.1002/ijgo.15431
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