- Participants and methods
This study was conducted from January 1st, 2015 to April 30th, 2016 in our hospital, a tertiary- care teaching hospital in Hubei province, in central China.
1.1 Ethical approval
The study protocol was a retrospective research, so the Ethical approval from hospital was not necessary. All parturient women requiring the NA service in this work 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. Among the members, 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 among the experts from NPLD through WeChat (the most popular online chat platform in China designed by Tencent Company), and the care givers from our hospital had more than 5 years of work experience in the department of anesthesia (attending physician) and NPLD experts took at least 7 days for field guidance in our hospital .
Before May 1st, 2015, NA was not available in labor and delivery suite. 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, and 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 operative suite for intrapartum CD, with 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 consisting of 12 members 12 members (Supplementary file 1) from American travelled to our hospital to give us a one-week training[7]. 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 staff) practiced the drills , and finally multidisciplinary debriefings were held at the end of each day. The practiced drills included 5-minute crash CD to deal with very urgent for mothers and children, how to deal with neurological complications, how to use operative instrument, how to reduce the rate of episiotomy, and how to perform resuscitation of neonatal asphyxia.
1.4 Data sources
This retrospective study was based on the maternity departments of a tertiary- level public hospital in Wuhan, China. This is a big birth center, with annual number of newborn babies of around 20.000 in recent 3 years. The delivery data were collected from the hospital’s information system from January 1st, 2015 to April 30 th, 2016. A total of 26,255 deliveries were included in our study, of which 53 cases of incomplete information, 28 cases of abortion before 28 weeks’ gestation, 821 cases of labor induction for fetal malformation, 60 cases of intrauterine fetal death were excluded. Therefore, a complete data of 25,293 cases was finally included (accounting for 96.3% of total data). Among them, 5,829 cases were from January 1st 2015 to April 30th 2015 before the implement of NA and 19,464 cases were from May 1st , 2015 to April 30th, 2016 after NA. The data 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), operative 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 based on maternal request, which lacks absolute or relative medical indications according to the classification standards above [10,11].
1.5 Neuraxial labor analgesia
Women undergoing vaginal delivery were evaluated 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, deranged coagulation profile, or drug allergy (Lidocaine, bupivacaine and fentanyl) were excluded from the study. For labor NA, following conditions need to be recorded: 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.
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. Then 2-3 mL of 2% lidocaine was applied before observing for 5 min to see if there was any adverse reaction. If no adverse reaction was observed, 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 10 mL of the mixed drugs every other hour.. The patient could push the PCEA button whenever she felt uncomfortable or any pain during delivery and labor. Each press releases 10 mL of mixed drugs, but the interval between the two presses must be at least 15 minutes. The continuous infusion rate was set to 0mL/h. Generally, anesthesia infusion was stopped after finishing the perineal stitch and was removed in two hours after delivery.
Maternal HR, NIBP and SpO2 as well as fetal heart rate were continuously monitored throughout the PCEA period. Each parturient woman was supervised by a specialized midwife, 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 selected pregnant women were informed that the left end of the scale represents “no pain” and that the right end represents the “most severe pain imaginable”. Then, they were instructed to mark the intensity of pain they were currently experiencing. For the NRS,a 11-point scale was used, with “0” representing “no pain” and “10” representing the “most severe pain imaginable.” All pain assessments were performed by an anesthesiologist before and after NA. After delivery, a questionnaire survey on the satisfaction on the NA effect was carried out 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 to teach them how to improve compliance during analgesia. Women undergoing vaginal delivery were evaluated 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 could also 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.