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Completed

NCT Number: NCT03442634

Early Versus Traditional Oral Hydration After Cesarean Section

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

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Key information

Conditions

Gastrointestinal Motility and Defecation Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams Maternity Hospital

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Hydration

Other

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

Other names: Early Oral Hydration

Traditional Oral Hydration

Other

this group will start oral hydration 6 hours after cesarean section

Other names: Delayed Oral Hydration

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Early Versus Traditional Oral Hydration After Cesarean Section; A Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 22, 2018
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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