1. Participants and methods
This study was conducted from May 1st, 2015 to April 30th, 2016 in our hospital, a tertiary- care teaching hospital in Hubei province, in the central of China.
1.1 Ethical approval
The study protocol was approved by the Ethics Committee of Maternal and Child Health Hospital of Hubei Province (Record No. 2015008) on September 23th, 2017. All parturient women requiring the NA service had signed informed consent.
1.2 Preparation stage of NA in our hospital
On March 1st, 2015, an organizing committee of NA was founded, which consisted of 10 members from our hospital, including administrators, anesthesiologists, obstetricians, neonatologist, nurses, midwives, and 3 experts from NPLD team. Of the members in the founded committee, three experts were born and educated in China and then immigrated to the United States for further academic development. They were fluent in both Mandarin and English and familiar with Western standards of obstetric care. In our hospital, a meeting is regularly organized 1-2 times a week. Questions would be discussed and communicated with the experts from NPLD through WeChat (the most popular online chat platform in China designed by Tencent Company), and the care givers of operator from our hospital were versed in the institution of epidural and had more than 5 years of work experience in the department of anesthesia(attending physician) and took turns to observe at least 7 days in the hospitals that had helped by NPLD in China.
Before May 1st, 2015, cesarean section could not be carried out in labor and delivery suite. The process can be described as that all pregnant women with labor onset were generally transferred to labor and delivery suite when the dilation of cervix was more than 1 cm. If intrapartum CD was needed in labor, they would be transferred to the operating suite. In our labor and delivery suite, various . However, during labor, no NA could be provided, nearly 20% of them chose water immersion during first stage of labor. All of the parturient women received bilateral perineal block anesthesia when the fetal head was crowned. After delivery, all of postpartum women would be returned to maternity room again.
After May 1st, 2015, with the help of NPLD team via WeChat, NA could be provided every day at any time in our labor and delivery suite. One of our labor and delivery suites (total 10 rooms) was also set as operation suite for intrapartum CD, in which there would be an anesthesiologist and an anesthesia nurse on duty every day, two shifts a day, at 8:00am and 17:00 pm, respectively.
1.3 The NPLD program in our hospital
From June 21 to 27 of 2015, a professional NPLD team from American travelled to our hospital to give us a one-week training. This American team [7] consisted of 4 obstetric anesthesiology attending physicians, 2 anesthesiology residents, 1 obstetrician, 1 labor and delivery nurse, 1 neonatologist, and 3 interpreters (Supplementary file 1). The NPLD schedule included seven different themes distributed in 7 days, (Orientation Agenda, Mother Safety Day, Baby Safety Day, No Pain Day, Crash Day, Patient Satisfaction Day, and Conference Day). The training was conducted in a typical “hands-on” pattern. First, the trainer from the team gave an overall introduction about the training, and then trainees (Chinese medical stuff) practiced the drills and the actual care of patients under the guidance of the experts from NPLD program, and finally multidisciplinary debriefings were held at the end of each day. The practiced drills included 5-minute crash CD, how to deal with neurological complications in labor and delivery suite, how to use operation instrument during vaginal delivery, how to reduce the rate of episiotomy, and how to perform resuscitation of neonatal asphyxia.
1.4 Data sources
This retrospective study focused on the maternity departments of a tertiary- level public hospital in Wuhan, China. This is a big birth center, where the annual number of newborn babies were around 20.000 in recent 3 years. The delivery data were collected from the hospital’s information system from May 1st, 2015 to April 30 th, 2016. A total of 20 174 deliveries were included in our study, of which 40 cases of incomplete information, 20 cases of abortion before 28 weeks’ gestation, 601 cases of labor induction for fetal malformation, 49 cases of intrauterine fetal death were excluded. Therefore, a complete data of 19 464 cases was finally included (accounting for of all the data 96.48%). The data set contains information such as demographic data, mother’s age, gravidity, parity, date of delivery, principal diagnosis of maternal or fetal pregnancy-related complications, gestational age at delivery, mode of delivery, primary indications of CD, maternal request cesarean delivery(MRCD), intrapartum CD, whether or not using NA, episiotomy, postpartum hemorrhage (PPH), operation vaginal delivery, neonatal asphyxia. (See Fig 1)
In China, CD with medical indications can be divided into CD with absolute medical indications and CD with relative medical indications (for instance age more than 35 years). In our study, MRCD refers to a cesarean delivery on maternal request, which lacks any medical indications of absolute and relative medical indication according to the classification standards above [10,11].
1.5 Neuraxial labor analgesia
Women undergoing vaginal delivery were evaluated both by anesthesiologist and obstetrician to assess their desire for and suitability for NA once their cervical dilation was greater than 1 cm. Parturient women who had any systemic and local sepsis, had deranged coagulation profile, or had drug allergy (Lidocaine, bupivacaine and fentanyl) were excluded from the study. The detail records for NA can be listed according to nulliparous or parous, spontaneous labor or medicine induced labor, full-term delivery or premature delivery, spontaneous vaginal delivery or instrument assisted vaginal delivery or intrapartum CD. Except for
Epidural analgesia was initiated in the left lateral decubitus position. A sterile preparation with 1% alcohol iodophor was applied by an anesthesiologist after at least 500 mL of Ringer’s lactate solution was administered by an anesthesia nurse. Then, an 18-gauge epidural catheter was inserted into the epidural space at the L3-4 or L4-5 interspace. After giving 2-3 mL test dose of 2% lidocaine, if there was no adverse reaction after 5 min, the catheter was fixed and connected to a patient controlled epidural analgesia (PCEA) pump (Master PCA pump, Fresenius Kabi USA, without continuous background infusion) to give 10 mL of mixed drugs of 0.08% ropivacaine +2ug/mL fentanyl. The PCEA pump was set to an automatic mode to deliver a 10 mL dose with a lockout time of 1 hour. We advised the patient to push the PCEA button whenever she felt uncomfortable. If the pain relief was inadequate, 15 minutes after having activated the PCEA bolus, a bolus dose of 10 mL was manually given. The continuous infusion rate was set to 0mL/h. Anesthesia infusion was stopped after finishing the perineal stitch and was removed in two hours after delivery generally.
Maternal HR, NIBP and SpO2 were continuously monitored throughout the PCEA period, meanwhile the fetal heart rate was monitored continuously as well. Parturient women were supervised by midwife one-on-one, and observed by anesthesia nurse at regular intervals. Common side effects such as nausea, somnolence, and pruritus were recorded by anesthesia nurses. The PCEA pump was administered by the parturient woman herself according to the instruction of anesthesiologist. Parturient women received exogenous oxytocin to obtain an enhanced labor process when they need. All fetal and maternal events, therapeutic interventions, outcome of labor, and Apgar score of new born at 1 and 5 min, PPH, and the mode of delivery were recorded. The analgesia effect was evaluated by visual analog scale (VAS) and numerical rating scale (NRS). The VAS was assessed on a 10 cm horizontal line. The patients were informed that the left end of the scale represented “no pain” and that the right end represented the “most severe pain imaginable”. The patients were then instructed to mark the intensity of pain they were currently experiencing on the line. For the NRS,an 11-point scale was used, with “0” representing “no pain” and “10” representing the “most severe pain imaginable.” All pain assessments were performed by the anesthesiologist before and after NA. After delivery, there was a questionnaire survey about labor including the satisfaction degree on the NA effect by scanning the code on WeChat.
1.6 Patient’s education
All our patients were educated by obstetrician in prenatal examination and the brochure for NA were given to them. On working day, midwives conducted specialized classes about NA for pregnant women to teach them how to improve compliance during analgesia. Women undergoing vaginal delivery were evaluated both by anesthesiologist and obstetrician to assess their desire for and suitability for NA once their cervical dilation was greater than 1 cm and all of them signed written informed consent for NA. Women undergoing vaginal delivery also could choose water immersion delivery once their cervical dilation was greater than 5 cm.
1.7 Data analysis
All data were inputted into SPSS software (v.19.0, SPSS Inc, Chicago, IL, USA) for statistical analysis. The Pearson correlation was adopted to evaluate the relationship among observed rates during 12 months. Value r and their 95% CIs were calculated. Cochran- Armitage Trend Test was carried out to evaluate the change trend of observed rates. All statistical tests were performed with 2-sided P values. If p value<0.05, the difference was considered statistically significant.