Early Versus Traditional Oral Hydration After Cesarean Section

NCT03442634 | Completed DMC

• 1 other identifier: cshydration
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Gastrointestinal Motility and Defecation Conditions

Keywords

bowel movements; cesarean section; oral hydration

Outcome Measures

Primary Outcomes (1)

• audible intestinal sounds

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

  first 12 hours after cesarean section

Secondary Outcomes (9)

• postoperative anorexia, nausea and vomiting

  first 24 hours after cesarean section

• time for first breast feeding

  first 24 hours after cesarean section

• abdominal distension

  first 24 hours after cesarean section

• amount of given intravenous fluids

  up to 24 hours after cesarean section

• need for pain analgesics

  up to 24 hours after cesarean section

Study Arms (2)

Early Hydration Group

EXPERIMENTAL

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

Traditional Hydration Group

ACTIVE COMPARATOR

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

Early Hydration OTHER

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

Also known as: Early Oral Hydration

Early Hydration Group

Traditional Oral Hydration OTHER

this group will start oral hydration 6 hours after cesarean section

Also known as: Delayed Oral Hydration

Traditional Hydration Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

Study Officials

• Bassem A Islam, Lecturer

  Ain Shams Maternity Hospital

  STUDY DIRECTOR

• Karim A Wahba, Professor

  Ain Shams Maternity Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrics and Gynaecology Resident

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: March 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)