Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06403215 |
| Other study ID # |
2018.2018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 11, 2017 |
| Est. completion date |
June 30, 2019 |
Study information
| Verified date |
May 2024 |
| Source |
Marmara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Study Sample This parallel, monocenter, randomized controlled experimental study was
conducted between January 2018 and April 2018 with the CONSORT guidelines in four maternity
units in Türkiye. Inclusion criteria for the study were as follows: Healthy, women who had a
cesarean section under general anesthesia, received primary school education at least, did
not have a chronic systemic disease, had no problems during pregnancy, had no history of
allergy, had a body mass index (BMI) of 18.50-24.99 kg/m2, with no previous abdominal
operation, and no complications during the operation.
Participants and Setting After being included in the study, the women were registered as a
participant and the study was carried out using opaque sealed envelopes numbered
sequentially. The study was carried out with four different groups determined by 22 factorial
trial levels. The sample size was determined as a total of 120 participants at 80% power and
95% confidence interval in consideration of the meta-analysis conducted on the data of the
subjects. Two different interventions- chewing gum and drinking fennel tea - were conducted
in this study.
Intervention Chewing gum group 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.
Fennel tea 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 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.
Data collection The amount of fluid taken by the patients was measured with a glass. The
amount of urine removed was calculated by checking the patient's bladder. The urinary
catheter was removed at the 6th hour.
Ethical Statement The study was conducted in accordance with the Declaration of Helsinki and
were approved by Ethics Committees (Protocol No: 09.2017.586). All patients signed informed
consents.
Data Analysis Chi-square and Fisher tests were used to compare categorical data. Spearman's
rank correlation coefficient was used to analyze and compare the statistical data. A value of
p<0.05 was accepted for the statistical significance of the comparisons.
