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CompletedNCT03566498Updated Jun 25, 2018

The Effect Of Immediate Versus Early Oral Hydration On Caesarean Section Post Operative Outcomes

An interventional study of Immediate hydration and Early hydration in Cesarean Section, sponsored by Ain Shams University. Completed. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-06-25.

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

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Aug 2016, registered Jun 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

The aim of this study is to evaluate the effect of immediate oral hydration initiated within 2 hours after uncomplicated Caesarean section

Read the detailed description

The aim of this study is to evaluate the effect of immediate oral hydration initiated within 2 hours after uncomplicated Caesarean section on the following post-operative outcomes:

  1. Post-operative nausea, vomiting, abdominal distention and abdominal cramps.
  2. Return of intestinal movements.
  3. Duration of intravenous fluid administration.
  4. Duration of hospital stay.
  5. Participant satisfaction
02

Conditions studied

  • Cesarean Section
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

    • Uncomplicated pregnancy.

      • Uncomplicated elective or emergency Caesarean section under regional anesthesia

Exclusion criteria

Exclusion Criteria:

    • Having medical disorders in the form of: hypertension, DM, and Hepatic disorders.

      • Having bleeding disorders.
      • Having intraoperative bowel or bladder injury.
      • Having intraoperative or immediate postoperative severe bleeding.
      • Having chronic gastrointestinal problems, like chronic constipation, peptic ulcer, esophagitis, hiatus hernia or irritable bowel syndrome.
      • Having abdominal adhesions
05

Study design

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

Study arms

  • Experimental
    Immediate hydration

    They will be allowed to start oral fluids immediately (within the first 2 hours post operatively) beginning with water or clear fluids (but not milk or soda containing drinks), the amounts will be according to their needs, solid food will be given gradually after tolerating the drinks and intravenous fluids will be given beside all of that and till the return of intestinal movements.

    Dietary Supplement: Immediate hydration

  • Active comparator
    Early hydration

    They will receive the routine intravenous fluids and the oral fluids will be given after 8 hours post operatively and gradually, solid food will be allowed after that gradually too and the intravenous fluids will be stopped after return of intestinal movements.

    Dietary Supplement: Early hydration

Interventions

  • Dietary supplementImmediate hydration

    They will be allowed to start oral fluids immediately (within the first 2 hours post operatively) beginning with water or clear fluids (but not milk or soda containing drinks), the amounts will be according to their needs, solid food will be given gradually after tolerating the drinks and intravenous fluids will be given beside all of that and till the return of intestinal movements

  • Dietary supplementEarly hydration

    They will receive the routine intravenous fluids and the oral fluids will be given after 8 hours post operatively and gradually, solid food will be allowed after that gradually too and the intravenous fluids will be stopped after return of intestinal movements.

06

What researchers measure

Primary outcomes

  1. Postpartum vomiting

    through a questionnaire patients were asked if they had vomiting or not and the nomber of attacks of vomitting

    Time frame: 48 hours

Secondary outcomes

  1. Return of intestinal movements

    through physical examination and auscultation of the intestinal sounds

    Time frame: 24 hours

  2. Duration of intravenous fluid administration

    Time frame: 24 hours

  3. Duration of hospital stay

    Time frame: 48 hours

  4. Participant satisfaction

    through a questionnaire patients were asked about degree of satisfaction 1- satisfied 2- neutral 3- not satisfied

    Time frame: 48 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03566498
Lead sponsor
Ain Shams University
Responsible party
Ahmed Abdel Shafy El Shahawy (Principal Investigator, Ain Shams University) — Principal investigator
First posted
Jun 25, 2018
Start date
Aug 1, 2016
Primary completion
Mar 2018
Completion
Apr 2018
Last update
Jun 25, 2018

Oversight

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

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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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