Clinical trial NCT03442634: Early Versus Traditional Oral Hydration After Cesarean Section
Official title: Early Versus Traditional Oral Hydration After Cesarean Section; A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Motility and Defecation Conditions
Keywords: bowel movements
cesarean section
oral hydration
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 2
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: this study helps us to compare and evaluate prospectively the benefits and safety of early hydration on bowel movement after cesarean section it includes two groups, a control group and a study group. the study group will get 200 ml of sugar free water within 1 hour after cs while the control group will get 200 ml of sugar free water 6 hours after cs

Detailed description: Traditionally, patients are not given fluids or food after cesarean sections until bowel function returns as evidenced by bowel sounds, passage of stool or flatus since , uneventful (uncomplicated) cesarean sections have no effect on intestinal functions and with putting in minds the need of the mother for early hydration , movement , breast feeding and early discharge; that is why we are investigating the effectiveness and safety of early oral hydration after cesarean sections

Eligibility criteria: Inclusion Criteria:

* Term Singleton Pregnancy.
* Uncomplicated Elective Cesarean Section.
* Time of Cesarean Section doesn't exceed 90 minutes.
* Average blood loss during and after cesarean section (doesn't exceed 1000cc).
* All patients will be under spinal anesthesia.

Exclusion Criteria:

* Postpartum Hemorrhage.
* Surgical Complications Such as intestinal injury.
* Medical disorders such as Diabetes and Hypertension
* Factors that may influence postpartum blood loss as anemia, multiple pregnancy and polyhydraminos.
* Use of tocolytic drugs

Primary outcomes:
measure: audible intestinal sounds
timeFrame: first 12 hours after cesarean section
Secondary outcomes:
measure: postoperative anorexia, nausea and vomiting
timeFrame: first 24 hours after cesarean section
measure: time for first breast feeding
timeFrame: first 24 hours after cesarean section
measure: abdominal distension
timeFrame: first 24 hours after cesarean section
measure: amount of given intravenous fluids
timeFrame: up to 24 hours after cesarean section
measure: need for pain analgesics
timeFrame: up to 24 hours after cesarean section
measure: length of hospital stay
timeFrame: up to 48 hours after cesarean section
measure: satisfaction measured with a visual analogue scale before patient discharge
timeFrame: first 6 hours after cesarean section
measure: time to first flatus
timeFrame: up to 48 hours after cesarean section
measure: time to first bowel movement
timeFrame: up to 72 hours after cesarean section
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Bassem A Islam, Lecturer
role: STUDY_DIRECTOR
affiliation: Ain Shams Maternity Hospital
name: Karim A Wahba, Professor
role: STUDY_DIRECTOR
References: