Clinical trial NCT02497794: The Effect of Gum Chewing on Bowel Function After Cesarean Section
Official title: Efficacy and Effectiveness of Gum Chewing on Bowel Function After Cesarean Section: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Splinter of Gum
Keywords: chew gum
bowel movements
cesarean section
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomised controlled trial that included 150 pregnant women undergoing cesarean in Sisli Ethal Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey. It was carried out in the period from October 1, 2015 to December 31, 2015. After operation, the participants are going to randomly assigned into two groups by using cards. The patients are going to randomized into two groups by using a sealed enveloped system.The patients in the study group, will chew one sugar less gum for 30 minutes in postoperative 3., 5. and 7. hours. The control group will be followed without chew gum. All patients will note the time of first rumbling of the stomach, first feeling of hunger and the first gas outlet.

Detailed description: For elective cases, all participants are going to given nothing by mouth since midnight before surgery, and all operations are going to perform in the morning. For those who had emergency cesarean section, nothing is going to given per oral for at least 4 hours before the start of the operation. Operation data is going to recorded including surgical setting, type of cesarean section, previous surgery, adhesion and operation time.

After operation, the participants are going to randomly assigned into two groups by using cards. The patients are going to randomized into two groups by using a sealed enveloped system. A blue card and an orange card are going to sealed in separate envelopes. Blue card means patients will chewgum.

The patients in the study group, will chew one sugar less gum for 30 minutes in postoperative 3., 5. and 7. hours. The control group will be followed without chew gum. Both patient groups will be mobilized in postoperative 6 hour and 8 hour after the operation, juicy food will be given. It will be introduced to solid foods after bowel movements and gas output occurs. All patients postoperatively 4, 6, 8, 10, 12, 24 and 48 hours will be examined and bowel sounds will be oscult. Gas evolution is still not, enema will be applied. All patients will note the time of first rumbling of the stomach, first feeling of hunger and the first gas outlet.

Eligibility criteria: Inclusion Criteria:

1. pregnant women who is at least 18 years of age
2. pregnant women whose body mass index is under 35
3. pregnant women who is going to have cesarean section.

Exclusion Criteria:

1. cesarean hysterectomy,
2. surgical management of severe postpartum hemorrhage
3. previous bowel surgery
4. women with history of drug consumption,especially opioids
5. water and electrolyte disturbances
6. pancreatitis or peritonitis
7. inability to chew gum
8. diabetes, pregnancies accompanied by coagulopathy like pre-eclampsia, hypothyroidism, muscular and neurological disorders
9. postoperative admission to intensive care unit
10. history of abdominal surgery except cesarean section
11. history of postoperative ileus
12. patients with drains

Primary outcomes:
measure: Postoperative time to return to active bowel movements
timeFrame: up to 48 hours
Secondary outcomes:
measure: Postoperative infection rates and early discharge
timeFrame: up to 48 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Etfal Research and Training hospital, Obstetrics and gynecology department
state: Marmara
Study officials:
affiliation: Sisli etfal
name: Fatma YAZICI YILMAZ
role: PRINCIPAL_INVESTIGATOR
affiliation: Sisli etfal
name: Begüm AYDOGAN
role: STUDY_DIRECTOR
References: