A Retrospective Study on the Effectiveness and Safety of Macrogol 4000, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride in Pregnant Women with Chronic Constipation

A Retrospective Study on the Effectiveness and Safety of Macrogol 4000, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride in Pregnant Women with Chronic Constipation - A Retrospective Study on the Effectiveness and Safety of Macrogol 4000, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride in Pregnant Women with Chronic Constipation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046499

Enrollment

Registered

2021-12-28

Start date

2021-11-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Constipation

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Pregnant women over 20 years old Patients diagnosed with chronic constipation who have less than 3 bowel movements per week Patients who were administered Macrogol preparations for the first time between October 1, 2020 and July 31, 2021 (Concomitant use of other drugs for the treatment of constipation should be allowed) Patients whose therapeutic benefit outweighs the risk

Exclusion criteria

Exclusion criteria: Patients who have history of Macrogol allergies Patiants who have presence or suspicion of Intestinal obstruction , Intestinal perforation, Severe Inflammatory bowel disease(Ulcerative colitis, Crohn's disease, toxic megacolon) Patiants who have presence or suspicion of organic constipation Patients who received the Macrogol preparation outside the approved dosage and administration

Design outcomes

Primary

Measure	Time frame
Comparison of the frequency of bowel movements before and after 4 weeks of treatment by Macrogol	—

Secondary

Measure	Time frame
Change and Comparison of the frequency of bowel movements before, after 8 weeks and the end of treatment by Macrogol Comparison of Bristol Stool Form Scale (BSFS) before, after 4 weeks, after 8 weeks and the end of treatment by Macrogol Comparison of CSS before, after 4 weeks, after 8 weeks and the end of treatment by Macrogol Comparison of straining before, after 4 weeks, after 8 weeks and the end of treatment by Macrogol Responder rates Subpopulation analysis by patient background	—

Measure

Time frame

Change and Comparison of the frequency of bowel movements before, after 8 weeks and the end of treatment by Macrogol Comparison of Bristol Stool Form Scale (BSFS) before, after 4 weeks, after 8 weeks and the end of treatment by Macrogol Comparison of CSS before, after 4 weeks, after 8 weeks and the end of treatment by Macrogol Comparison of straining before, after 4 weeks, after 8 weeks and the end of treatment by Macrogol Responder rates Subpopulation analysis by patient background

—

Countries

Japan

Contacts

Public ContactYojiro Maruyama

Juntendo University Nerima Hospital Department of Obstetrics and Gynecology

ymaruya@juntendo.ac.jp03-5923-3111

Outcome results