Clinical trial NCT02809027: Efficacy of Ginger in the Prevention of Abdominal Distention in Post Cesarean Section Patient
Official title: A Randomized Double-blind Placebo-controlled Trial on the Efficacy of Ginger in the Prevention of Abdominal Distention in Post Cesarean Section Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Cesarean Section Patient
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine ginger is effective in the prevention of abdominal distention in post Cesarean section patient.


Eligibility criteria: Inclusion Criteria:

* Post cesarean section women

Exclusion Criteria:

* allergic to ginger
* time of cesarean section more than 1 hour
* perform another operation such as appendectomy, cystectomy
* former use carminative drugs
* already have abdominal distention

Primary outcomes:
measure: incidence abdominal distention as measured by diary chart (history taking and examination)
timeFrame: 72 hours
Secondary outcomes:
measure: Maternal satisfaction as measured by questionaire
timeFrame: 72 hours
measure: Quality of life as measured by questionaire
timeFrame: 72 hours
measure: nausea vomiting as measured by questionaire
timeFrame: 72 hours
measure: first time to pass flatus/feces as measured by diary chart
timeFrame: 72 hours
measure: number of carminative drug use as measured by questionaire
timeFrame: 72 hours
measure: side effect as measured by questionaire
timeFrame: 72 hours
Other outcomes:
Locations:
Study officials:
affiliation: Chulalongkorn University
name: Vorapong Phupong, M.D.
role: STUDY_DIRECTOR
References:
citation: Carroll J, Alavi K. Pathogenesis and management of postoperative ileus. Clin Colon Rectal Surg. 2009 Feb;22(1):47-50. doi: 10.1055/s-0029-1202886.
citation: Chaiyakunapruk N, Kitikannakorn N, Nathisuwan S, Leeprakobboon K, Leelasettagool C. The efficacy of ginger for the prevention of postoperative nausea and vomiting: a meta-analysis. Am J Obstet Gynecol. 2006 Jan;194(1):95-9. doi: 10.1016/j.ajog.2005.06.046.
citation: O'Hara M, Kiefer D, Farrell K, Kemper K. A review of 12 commonly used medicinal herbs. Arch Fam Med. 1998 Nov-Dec;7(6):523-36. doi: 10.1001/archfami.7.6.523.
citation: Ushiroyama T, Sakuma K, Souen H, Nakai G, Morishima S, Yamashita Y, Kamegai H. Xiong-gui-tiao-xue-yin (Kyuki-chouketsu-in), a traditional herbal medicine, stimulates lactation with increase in secretion of prolactin but not oxytocin in the postpartum period. Am J Chin Med. 2007;35(2):195-202. doi: 10.1142/S0192415X07004734.
citation: Gibstein A, Cooper JJ, Wisot AL, Rosenthal AH. Prevention of postoperative abdominal distention and discomfort with simethicone. Obstet Gynecol. 1971 Sep;38(3):386-90. No abstract available.
citation: Hu ML, Rayner CK, Wu KL, Chuah SK, Tai WC, Chou YP, Chiu YC, Chiu KW, Hu TH. Effect of ginger on gastric motility and symptoms of functional dyspepsia. World J Gastroenterol. 2011 Jan 7;17(1):105-10. doi: 10.3748/wjg.v17.i1.105.