NCT06403215

Brief Summary

Aim: Postoperative ileus after cesarean section is a problem that significantly prolongs hospital stay and increases perioperative costs. The ability of postoperative fennel tea consumption to produce bowel movement is unclear and needs to be studied. This study aimed to determine the effect of chewing gum and drinking fennel tea on intestinal motility after cesarean section. Methods: The study was conducted in postnatal care wards between January 2018 and April 2018. Simple randomization was used to assign women to the study arms. Data were collected during Pregnancy Constipation Diagnostic Scale, Data Collection and Follow-up Form were collected.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

May 2, 2024

Last Update Submit

May 6, 2024

Conditions

Keywords

Cesareanchewing gumfennel teaBowel sounds

Outcome Measures

Primary Outcomes (3)

  • bowel sounds

    Bowel sounds were recorded every 2 hours.

    12 hours

  • flatulation

    .The time of the first flatulation were determined by asking the women themselves and this information was then recorded using the study form.

    24 hours

  • defecation

    .The time of the first defecation were determined by asking the women themselves and this information was then recorded using the study form.

    48 hours

Study Arms (4)

Chewing gum group

EXPERIMENTAL

Women in this group chewed sugar-free and non-xylite gum for 15 minutes every two hours (2nd, 4th, and 6th) following the cesarean operation. As a result of their meta-analysis study, a study reported that chewing gum for 15 minutes every two hours until oral intake started bowel sounds in a shorter time. Therefore, in the current study, women chewed gum for 15 minutes every two hours, following two hours after the cesarean operation. The bowel sounds of the women were listened to and their flatulation times were recorded before and after gum chewing for 15 minutes every two hours. When women were allowed oral intake, gum-chewing activity was terminated completely. Data for the first time of flatulation and the bowel sounds were collected by verbally asking women, and these data were recorded in the follow-up form.

Other: Chewing gum group

Fennel tea group

EXPERIMENTAL

Women in this group started oral intake 6 hours after cesarean delivery and were allowed to drink 2 grams of fennel tea in the 6th, 8th, and 10th hours (a total of 6 grams of fennel tea). Fennel seeds (2 grams) were put into 150 ml water, boiled at a temperature of 100 °C, and left for 20 minutes. Women were then instructed to drink the tea. Bowel sounds were recorded every 2 hours, before and after drinking the fennel tea. The time of the first flatulation and the first bowel sounds were determined by asking the women themselves and this information was then recorded using the study form.

Other: Fennel tea group

Chewing gum+Fennel tea group

EXPERIMENTAL

Women in this group chewed sugar-free and non-xylite gum for 15 minutes every two hours (2nd, 4th, and 6th) following the cesarean operation. As a result of their meta-analysis study, a study reported that chewing gum for 15 minutes every two hours until oral intake started bowel sounds in a shorter time.Women were then instructed to drink the tea. Bowel sounds were recorded every 2 hours, before and after drinking the fennel tea. The time of the first flatulation and the first bowel sounds were determined by asking the women themselves and this information was then recorded using the study form.

Other: Chewing gum+Fennel tea group

Control group

EXPERIMENTAL

Researcher sounded in bowel movement as hospital protocols.

Other: Control group

Interventions

Women in this group chewed sugar-free and non-xylite gum for 15 minutes every two hours (2nd, 4th, and 6th) following the cesarean operation.

Chewing gum group

Women in this group started oral intake 6 hours after cesarean delivery and were allowed to drink 2 grams of fennel tea in the 6th, 8th, and 10th hours (a total of 6 grams of fennel tea).

Fennel tea group

Women in this group both chewed sugar-free and non-xylite gum for 15 minutes every two hours (2nd, 4th, and 6th) following the cesarean operation and started oral intake 6 hours after cesarean delivery and were allowed to drink 2 grams of fennel tea in the 6th, 8th, and 10th hours (a total of 6 grams of fennel tea).

Chewing gum+Fennel tea group

No intervention

Control group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Without chronic disease
  • women who had a cesarean section under general anesthesia
  • received primary school education at least
  • women had no problems during pregnancy
  • who had no history of allergy
  • who had a body mass index (BMI) of 18.50-24.99 kg/m2
  • no previous abdominal operation
  • no complications during the operation.

You may not qualify if:

  • age\<18 years
  • multiparous women
  • who had a cesarean section under spinal anesthesia
  • spontaneous onset of labor
  • who had a chronic systemic disease
  • who had problems during pregnancy
  • who had any history of allergy
  • who had a body mass index (BMI) of \<24.99 kg/m2
  • who had a previous abdominal operation, and complications during the operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ileus

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Rüveyda Ölmez Yalazı, PhDc

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

May 2, 2024

First Posted

May 7, 2024

Study Start

September 11, 2017

Primary Completion

April 30, 2018

Study Completion

June 30, 2019

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations