The Effect of Post Cesarean Section Protocol of Care on Early and Follow up Outcomes
Condition: Cesarean Section
Study type: Interventional

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.
    

Intervention name(s): Oral fluids; Chewing gum
Intervention type(s): Other; Other
Intervention description(s): 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.; Chewed free sugar gum for 15 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
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
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Oral fluid; Chewing gum; Post cesarean; Intestinal movement; Passage of flatus