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Early Versus Traditional Oral Hydration After Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03442634
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Hassan Mohamed Mostafa, Ain Shams University

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

Condition or disease Intervention/treatment Phase
Gastrointestinal Motility and Defecation Conditions Other: Early Hydration Other: Traditional Oral Hydration Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Early Versus Traditional Oral Hydration After Cesarean Section; A Randomized Clinical Trial
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Hydration Group
this study group will get 200 ml of sugar free water within 1 hour after cesarean section followed by oral hydration as per patients' desire then starting semisolid and solid foods when patients are open bowel Intervention: Early Oral Hydration
Other: Early Hydration
this group will start oral hydration within 1 hour after cesarean section
Other Name: Early Oral Hydration

Active Comparator: Traditional Hydration Group
this study group will get 200 ml of sugar free water after 6 hours after cesarean section followed by oral hydration as per patients' desire then starting semisolid and solid foods when patients are open bowel Intervention: Traditional Oral Hydration
Other: Traditional Oral Hydration
this group will start oral hydration 6 hours after cesarean section
Other Name: Delayed Oral Hydration




Primary Outcome Measures :
  1. audible intestinal sounds [ Time Frame: first 12 hours after cesarean section ]
    auscultation of intestinal sounds hourly for the first 12 hours after cesarean section


Secondary Outcome Measures :
  1. postoperative anorexia, nausea and vomiting [ Time Frame: first 24 hours after cesarean section ]
    recording the incidence of git upset symptoms in the first 24 hours after cesarean section

  2. time for first breast feeding [ Time Frame: first 24 hours after cesarean section ]
    recording the time of first breast-feed

  3. abdominal distension [ Time Frame: first 24 hours after cesarean section ]
    recording the incidence of abdominal distension after cesarean section

  4. amount of given intravenous fluids [ Time Frame: up to 24 hours after cesarean section ]
    recording amount in ml of given iv fluids

  5. need for pain analgesics [ Time Frame: up to 24 hours after cesarean section ]
    recording the amount of pain analgesia needed after cesarean section

  6. length of hospital stay [ Time Frame: up to 48 hours after cesarean section ]
    recording the length of patients' stay at hospital

  7. satisfaction measured with a visual analogue scale before patient discharge [ Time Frame: first 6 hours after cesarean section ]
    measuring satisfaction level after cesarean section

  8. time to first flatus [ Time Frame: up to 48 hours after cesarean section ]
    recording the time at which the patient had its first flatus

  9. time to first bowel movement [ Time Frame: up to 72 hours after cesarean section ]
    recording the time at which the patient had her first bowel motion



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442634


Locations
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Egypt
Ain Shams Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Bassem A Islam, Lecturer Ain Shams Maternity Hospital
Study Director: Karim A Wahba, Professor Ain Shams Maternity Hospital

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Responsible Party: Mohamed Hassan Mohamed Mostafa, Obstetrics and Gynaecology Resident, Ain Shams University
ClinicalTrials.gov Identifier: NCT03442634     History of Changes
Other Study ID Numbers: cshydration
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohamed Hassan Mohamed Mostafa, Ain Shams University:
bowel movements
cesarean section
oral hydration