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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04338737
Other study ID # MS-235-2019
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2020
Est. completion date April 2021

Study information

Verified date April 2020
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

3 different post ceseraen secton feeding regmen are compared


Description:

300 women admitted to the labor and delivery unit in kasr Elainy teaching hospital, Following the decision to perform a cesarean section because of obstetric indications. The study involved only elective cesarean sections.

The 300 patients participated in this work and will be randomly and equally divided into three groups:

1. Group A :

It consists of 100 patients that will be allocated for early post-operative oral feeding receiving water and clear fluid approximately 2 hours after surgery, followed by soft food and regular diet 4 hours later irrespective to intestinal sounds, flatus or stool.

2. Group B :

It consists of 100 patients that will be allocated for early Postoperative oral feeding receiving water and clear fluid approximately 2 hours after surgery till the return of intestinal sounds, then soft food and regular diet later on.

3. Group C :

It consists of 100 patients that will receive no oral feeding till passage of flatus instead 2 to 3 Litres of intravenous fluid will be used for feeding. Water and fluid will be then offered, followed by soft foods and then a regular diet.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date April 2021
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Maternal age from 20 to 40.

- Primigravida and previous 1 or two cesarean section.

- Elective cesarean section.

- Regional anaesthesia.

- Singleton pregnancy

Exclusion Criteria:

- Medical disorders as (sever preeclampsia, diabetes, liver or kidney diseases).

- Intraoperative intestinal injury.

- Previous major abdominal surgery except cesarean section.

- Obstructed labor with

Study Design


Related Conditions & MeSH terms


Intervention

Other:
timming of feeding
post-operative oral feeding receiving water and clear fluid after surgery, followed by soft food and regular diet

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kasr El Aini Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary duration minutes till return of bowel sound hearing of intestinal sound time interval in minutes from the end of surgery till the return of intestinal sound
Primary maternal satisfaction from time of initiation of oral feeding after caesarean section. Assessment of patient satisfaction before discharge from hospital using visual analogue scale. before discharge from hospital (range of 24 hours)
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