NCT05300750

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

Completed NA Last updated 6 April 2022

What this trial tests

NA trial testing Oral fluids in Cesarean Section in 150 participants. Completed in 27 February 2022.

Timeline

1 May 2019

Primary endpoint
30 January 2022

27 February 2022

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	150
Start date	1 May 2019
Primary completion	30 January 2022
Estimated completion	27 February 2022
Sites	1 location across Egypt

Drugs / interventions tested

• Oral fluids
• Chewing gum — full drug profile →

Conditions studied

• Cesarean Section — all drugs for Cesarean Section →

Sponsor

Cairo University

Who can join

Adults 20 to 35, female only, with Cesarean Section. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.