Clinical trial NCT05300750: The Effect of Post Cesarean Section Protocol of Care on Early and Follow up Outcomes
Official title: The Effect of Post Cesarean Section Protocol of Care on Early and Follow up Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: Oral fluid
Chewing gum
Post cesarean
Intestinal movement
Passage of flatus
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: PREVENTION

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.

Detailed 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, and 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. An ethical approval was obtained from the ethical research committee of the faculty of nursing, (No.15-2019). As well as, an official permission was taken from authoritative personnel at obstetrics and gynecology hospital and postpartum department to conduct the study The researcher introduced herself to the post C/s mothers who met the inclusion criteria and informed them about the purpose and nature of the study to obtain their acceptance to participate in the study, all the mothers were informed that participation in the study is voluntary and they could withdraw from the study at any time without any negative consequences. Written consent was obtained prior to the commencement of data collection. Anonymity and confidentiality related to the information to the identity of each post C/s mothers were kept in a locked file. File folder was identified only by numbers; also, recorded data were assured through coding of data and assuring that. An official permission for conducting this study was obtained from the administrative authorities of El Kasr El Aini hospitals. Gathering data took place from the period of May 2019 up to November 2020. Six cases/weak for 25 weeks (i.e. the Covid -19 condition disturbed the continuity of the process). Recruitment of participant and Randomization Upon full evaluation and matching the diagnosis, all mothers who met the inclusion criteria were enrolled in the trial .randomization was achieved using randomly permuted blocks of different sizes (3, 6, and 9) .each block used for one time except block nine which repeated twice. The ratio of intervention groups versus the standard hospital care was 1:1:1 when the intervention group of oral fluid took symbol (A) and the intervention group of chewing gum took symbol (B) and the standard hospital care group took symbol (C) for the distribution of permuted blocks .the permuted blocks 3disturbuted 18 cases, .the permuted blocks 6 distributed 36cases, while the permuted blocks 9 distributed 54 cases and repeated twice up till the total number of sample was reached (I.e. 150). Concealed opaque envelopes with sequential numbers were utilized. A team of two clinical instructors who were trained in the maternal and newborn health nursing department were shared in the allocation of the mothers to different groups after receiving the appropriate training. Mothers, who met the inclusion criteria, were assigned to the interventions groups or the control group .utilizing the sequential opaque envelops. The main researcher was outside the process of allocation. Blinding and masking: Regarding the nature of the intervention there were difficulties in masking both the participant and the researcher. The researcher interviewed the mothers, explained the purpose of the study and written consent was obtained. Mothers were assured that their participation in the study was voluntary and that privacy and confidentiality were ensured. Baseline data of demographic characteristic and obstetrical history were gathered. In addition to the intestinal movement sound, passing of flatus, presence of nausea or vomiting .which carried two hours after cesarean section. 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. Two stages of follow up; first: evaluation of the intervention's effect at hospital and before discharge. Second: follow up of mothers at home. First: evaluation of the intervention effect: In this stage as described before all mothers in both intervention groups received the planned protocol of care (i.e. oral fluids or gum besides the ambulation and breathing exercises), and had been evaluated for intestinal sound, passage of flatus, and timing of breast feeding at the time points of 4, 6 and 8 hours post cesarean section. Second: follow up of mothers at home: In this stage, mothers were followed at third, seventh days post-cesarean section at home by phone. The researcher assessed their abilities to carry their routine and daily activities as well as ensured that there were no complication appeared or re-hospitalization occurred. Further at ten days post cesarean section, each mother came to postpartum clinic in order to check the wound condition and overall health condition and removed the C.S. sutures.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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

Primary outcomes:
measure: Intestinal sound
timeFrame: From 4hours post-cesarean section up to 8 hours later
measure: Passage of flatus
timeFrame: From 4hours post-cesarean section up to 8 hours later
measure: Duration of hospital stay
timeFrame: From 1 hour post-cesarean section up to 12 hours later
Secondary outcomes:
Other outcomes:
Locations:
city: Faisal
country: Egypt
facility: Eman Said Abo El Ella Hassan
state: Giza
Study officials:
affiliation: Faculty of Nursing- Cairo University
name: Shadia A Abdel Kader Hassan, Professor
role: STUDY_CHAIR
affiliation: Faculty of Nursing- Cairo University
name: Magda A Ahmed Fawaz, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Ahmed A Mahmoud Sayed, Professor
role: STUDY_DIRECTOR
References: