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CompletedNCT03442634Updated Aug 9, 2018

Early Versus Traditional Oral Hydration After Cesarean Section

An interventional study of Early Hydration and Traditional Oral Hydration in Gastrointestinal Motility and Defecation Conditions, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-09.

Sponsored by Ain Shams University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Sex
Female
01

Study 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

Read the 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

02

Conditions studied

  • Gastrointestinal Motility and Defecation Conditions

Keywords

  • bowel movements
  • cesarean section
  • oral hydration
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherEarly Hydration

    this group will start oral hydration within 1 hour after cesarean section

    Also known as: Early Oral Hydration

  • OtherTraditional Oral Hydration

    this group will start oral hydration 6 hours after cesarean section

    Also known as: Delayed Oral Hydration

05

What researchers measure

Primary outcomes

  1. audible intestinal sounds

    auscultation of intestinal sounds hourly for the first 12 hours after cesarean section

    Time frame: first 12 hours after cesarean section

Secondary outcomes

  1. postoperative anorexia, nausea and vomiting

    recording the incidence of git upset symptoms in the first 24 hours after cesarean section

    Time frame: first 24 hours after cesarean section

  2. time for first breast feeding

    recording the time of first breast-feed

    Time frame: first 24 hours after cesarean section

  3. abdominal distension

    recording the incidence of abdominal distension after cesarean section

    Time frame: first 24 hours after cesarean section

  4. amount of given intravenous fluids

    recording amount in ml of given iv fluids

    Time frame: up to 24 hours after cesarean section

  5. need for pain analgesics

    recording the amount of pain analgesia needed after cesarean section

    Time frame: up to 24 hours after cesarean section

  6. length of hospital stay

    recording the length of patients' stay at hospital

    Time frame: up to 48 hours after cesarean section

  7. satisfaction measured with a visual analogue scale before patient discharge

    measuring satisfaction level after cesarean section

    Time frame: first 6 hours after cesarean section

  8. time to first flatus

    recording the time at which the patient had its first flatus

    Time frame: up to 48 hours after cesarean section

  9. time to first bowel movement

    recording the time at which the patient had her first bowel motion

    Time frame: up to 72 hours after cesarean section

06

Study locations

1 site
  • Ain Shams Maternity Hospital
    Cairo, Egypt
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03442634
Lead sponsor
Ain Shams University
Responsible party
Mohamed Hassan Mohamed Mostafa (Obstetrics and Gynaecology Resident, Ain Shams University) — Principal investigator
First posted
Feb 22, 2018
Start date
Mar 1, 2018
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Last update
Aug 9, 2018

Study contacts

Bassem A Islam, Lecturer
study director · Ain Shams Maternity Hospital
Karim A Wahba, Professor
study director · Ain Shams Maternity Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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