The Effect of Post Cesarean Section Protocol of Care on Early and Follow up Outcomes

NCT05300750 | Completed DMC

• 1 other identifier: No.15-2019
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current study is to evaluate the effect of post cesarean section protocol of care on early and follow up outcomes.The criteria for inclusion were; mothers can read and write, primipara or multipara who was admitted to postpartum unit, age ranged between 20-35 years, under epidural anesthesia, gestational age (≥ 37 weeks) newborn, uncomplicated elective or under C/s for abnormal lie, abnormal presentation, cephalo- pelvic disproportion. Mothers with any medical disorders or post C/s complications were excluded from the present study.Two post C/s regimens were approached for two groups of interventions; 1) oral fluids group (A) and 2) chewing gum group (B) versus standard hospital care group (C). Both interventions groups (A\&B) received early ambulation, breathing and coughing exercises protocol of care besides. Both groups of intervention received the proposed protocol at 2, 4, 6 hours post -cesarean. Regarding to the intervention group (A) in which mothers received oral fluid, the starting amount of fluid after 2 hours post C/s should be 5cm and then increase gradually to be 45-50 cm of oral fluid at 4 hours post C/s and 100 cm each hours later. The oral fluid intake was in form of peppermint or anise. While in the intervention group (B), mothers chewed free sugar gum for 15 minutes in the same time points of group (A) at 2, 4 and 6 hours after C/s. Further, ambulation of mothers started after four hours post C/s. Furthermore, before discharge both intervention groups were received booklet contained health education for healthy diet with balanced meal, different position for breast feeding, dealing with C/s wound, dealing with post C/s minor discomfort, information related to postpartum danger signs (i.e. foul vaginal discharge, sever incision pain, discharge from suture line, painful calf muscle, burning sensation on urination, heavy vaginal bleeding, symptoms of anxiety. Further, each mother had been informed that if any minor discomforts or any danger signs appeared and couldn't deal with, contact the researcher directly to help in management and referral with available phone numbers. Also, each mother was informed to come for obligatory postpartum clinic for follow up on day 10 after cesarean section for complete check and follow up.

Conditions

Cesarean Section

Keywords

Oral fluid; Chewing gum; Post cesarean; Intestinal movement; Passage of flatus

Outcome Measures

Primary Outcomes (3)

• Intestinal sound

  Hearing of intestinal sound after cesarean section after receiving the intervention (oral fluid or chewing gum, two hours post ceserean section). Measured by post cesarean section early assessment sheet. This tool divided into three parts; part (1) includes base line data of the mothers such as physiological condition after 2 hours post Cs delivery (vital signs, intestinal movement, passage the flatus, abdominal distension, nausea, vomiting, and colic related to distention). Part: (2) includes data related to assessment of mothers condition after first ambulation 4 hours post Cs delivery (i.e. the time of early ambulation, feeling of drowsiness in change position from sitting to standing or walking, ability to walk, ability to sit;. While the third part includes assessment of mothers' abilities to do breathing exercises.

  From 4hours post-cesarean section up to 8 hours later

• Passage of flatus

  Assessment of passage of flatus after receiving the intervention (oral fluid or chewing gum, two hours post ceserean section). Measured by post cesarean section early assessment sheet. This tool divided into three parts; part (1) includes base line data of the mothers such as physiological condition after 2 hours post Cs delivery (vital signs, intestinal movement, passage the flatus, abdominal distension, nausea, vomiting, and colic related to distention). Part: (2) includes data related to assessment of mothers condition after first ambulation 4 hours post Cs delivery (i.e. the time of early ambulation, feeling of drowsiness in change position from sitting to standing or walking, ability to walk, ability to sit;. While the third part includes assessment of mothers' abilities to do breathing exercises.

  From 4hours post-cesarean section up to 8 hours later

• Duration of hospital stay

  Duration of hospital stay after cesarean section. It measured by numbers of hours started immediately after C/S operation up till the time of hospital discharge.

  From 1 hour post-cesarean section up to 12 hours later

Study Arms (3)

Oral Fluid

EXPERIMENTAL

The oral fluid intake was in form of peppermint or anise

Other: Oral fluids

Chewing Gum

EXPERIMENTAL

Free sugar gum

Other: Chewing gum

Standard hospital care

NO INTERVENTION

Control group

Interventions

Oral fluids OTHER

Starting amount of oral fluid after 2 hours post C/s should be 5cm and then increase gradually to be 45-50 cm of oral fluid at 4 hours post C/s and 100 cm each hours later.

Oral Fluid

Chewing gum OTHER

Chewed free sugar gum for 15 minutes

Chewing Gum

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: Mothers in postaprtum period
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mothers can read and write
• Primipara or multipara who was admitted to postpartum unit
• Age ranged between 20-35 years
• Under epidural anesthesia, gestational age (≥ 37 weeks) newborn
• Uncomplicated elective or under C/s for abnormal lie
• Abnormal presentation, cephalo- pelvic disproportion.

You may not qualify if:

• \- Mothers with any medical disorders or post C/s complications

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Eman Said Abo El Ella Hassan

Faisal, Giza Governorate, 002, Egypt

Location

MeSH Terms

Interventions

Fluid Therapy; Chewing Gum

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Shadia A Abdel Kader Hassan, Professor

  Faculty of Nursing- Cairo University

  STUDY CHAIR

• Magda A Ahmed Fawaz, Professor

  Faculty of Nursing- Cairo University

  STUDY DIRECTOR

• Ahmed A Mahmoud Sayed, Professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Model Details: Randomized controlled trail (Parallel group design) is an experimental study design in which each subject is randomized to one of two or more distinct treatment/intervention groups. Those who are assigned to the same treatment are referred to as a treatment group

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 29, 2022
• Study Start: May 1, 2019
• Primary Completion: January 30, 2022
• Study Completion: February 27, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

EG (1)