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, located 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 number 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
First, an organizing committee of NA was founded on March 1st, 2015, which consisted 10 members from our hospital, including administrators, anesthesiologists, obstetricians, neonatologist, nurses, midwives, and 3 experts from NPLD team. The three experts were born and studied in China, 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).
Before May 1st, 2015, Cesarean section could not be carried out in delivery room.The process can be described as that all labor onset pregnant women were generally admitted to hospital in maternity room first, and then moved to delivery room till the dilation of cervix to 1 cm or more. If intrapartum CD was needed in labor they would be transferred to the general operating room. In our delivery room, the maternal service mode provided family member accompanying, various positions allowed, Daole, midwives during labor, but there were no anesthesiologists and CD could not be carried out. So during labor, no NA could be provided, nearly 20% of them chose water immersion during first stage of labor[9]. 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 maternal room again.
After May 1st, 2015, with the help of NPLD team via WeChat, NA could be provided every day at any time in any of our delivery rooms. One of our delivery rooms (total 10 rooms) was also set as operation room for CD. 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 for giving us a one-week training. This American team [7]consisted of 4 obstetric anesthesiology attending physicians, 2 anesthesiology residents, 1 obstetricians, 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 typically “hands-on” pattern. First, the trainer from the team gave an overall introduction of the training, and then trainees (Chinese medical stuff) practiced the drills, and the actual care of patients under the 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 room, how to use operation instrument during vaginal delivery, how to reduce the rate of episiotomy, and how to use resuscitation of neonatal asphyxia and so on.
1.4 Data sources
This retrospective study focused on the maternity departemts of one tertiary- level public hospitals in Wuhan, China. This is a big birth center, the annual number of new born babies was around 20.000 in recent 3 years. The delivery data were collected from the hospitals’ information systems from June 1st, 2015 to July 1st, 2016, and 20.174 deliveries were included in our study, in 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 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 require cesarean delivery(MRCD), intrapartum CD), whether or not using NA, episiotomy, postpartum hemorrhage (PPH), operation vaginal delivery, intrapartum CD, neonatal asphyxia. (detail shows in Fig 1: Flow Diagram)
In China, CD with medical indications can be divided into CD with absolute medical indications and CD with relative medical indications(for example: age more than 35 years). In our study, MRCD is a cesarean delivery on maternal request at term, which lacks any medical indications of absolute and relative medical indication according to the classification standards above[10,11].
1.5 Neuraxial labor analgesia
All parturient women undergoing vaginal delivery should be evaluated both by anesthesiologist and obstetrician to make sure if they need NA when their cervical dilation more than 1cm. The exclusion criteria included parturient women who had any systemic and local sepsis, had deranged coagulation profile, or had drug allergy (Lidocaine, bupivacaine and fentanyl and so on). 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, nature vaginal delivery or instrument assisted vaginal delivery or intrapartum CD. Except for NA, the other maternal service mode was the same.
Epidural analgesia was initiated in the left lateral decubitus position. A sterile preparation with 1% alcohol iodophor was applied by an anesthesiologist with sterile gloves, hat, and mask after an intravenous infusion was established, and at least 500 mL of Ringer’s lactate solution would be administered by anesthesia nurse. First, a 18-gauge epidural catheter was inserted into the epidural space at the L3–4 or L4–5 interspace by 3 cm deep, and then test was carried out by the injection of 2–3 mL of 2% lidocaine. If no side effect appears, the epidural catheter was connected to a PCEA pump (Master PCA pump, Fresenius Kabi USA, without continuous background infusion). 0.08% Ropivacaine with 2 ug/mL Fentanyl was used as the anesthetic drug. If the drug of the PCEA was finished, another one be reloaded. The every-time automatic injection rate of PCEA was 10 mL with a lockout interval of 1 h. The parturient women were told to press the button, each button pressing would inject 10 mL of drug, and the maximum injection(automatic and manual) limit within 30 min was 30 mL. When the cervical dilation was completed, the PCEA pump was discontinued.
Maternal body was continuously monitored for HR, NIBP and SpO2 throughout the PCEA period, meanwhile the fetal heart rate was monitored continuously as well. The parturient women were supervised by midwife one-by-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 patients 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 an questionnaire survey about labor including the satisfaction with the effect of NA by scanning the code on WeChat.
1.7 all kinds of rates
The rate of neuraxial labor analgesia basically refers to the ratio between the number of neuraxial labor analgesia cases and the number of total vaginal delivery cases.
The rate of CD basically refers to the ratio between the number of CD cases and the number of total delivery cases (including CD and vaginal delivery).
The rate of MRCD mean the ratio between the number of MRCD cases and the number of total CD cases.
The rates of neonatal asphyxia, episiotomy, PPH, operative vaginal delivery in vaginal delivery mean the ratio between the number of these cases and the number of vaginal delivery cases.
The rates of intrapartum CD, neonatal asphyxia, PPH in CD mean the ratio between the number of these cases and the number of CD cases.
1.8 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 used 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.