Objective
To study the effect of a departmental program designed to shorten the decision-to-delivery interval (DDI) for emergency cesarean section (ECS) for nonreassuring fetal heart rate (NRFHR) on maternal and neonatal outcome.
Study Design
A protocol for managing ECS that included documenting precise time-intervals, identification of delaying obstacles and debriefing of each case, was implemented from March 2011. All women who delivered by ECS for NRFHR, as the only indication were included. Detailed information regarding DDI, maternal intraoperative and postoperative complications, and neonatal early outcomes were compared before (period-P1) (−27 months) and after (period 2) (+27 months) program implementation.
Results
During 54 months of study, 593 ECS DDI were included. Mean DDI decreased at period 2 (12.3 ± 3.8 min, n = 301) compared with period 1 (21.7 ± 9.1 min, n = 292), P < .001. Rate of cord pH ≤7.1 and 5 min Apgar score ≤7 decreased at period 2 compared with period 1, P = .016 and P = .031, respectively. Worse composite neonatal outcome decreased at period 2 compared with period 1, 15.6% vs 32.2%, respectively, P ≥ .001. Composite maternal outcome did not differ between the groups. Worse neonatal outcome was dependent on time period (period 1), odds ratio, 2.12; 95% confidence interval, 1.27–3.55; P = .004 and on gestational age at delivery, odds ratio, 0.68; 95% confidence interval, 0.62–0.76; P < .001.
Conclusion
Introduction of a management protocol to shorten DDI in ECS for NRFHR was associated with improved early neonatal outcome without change in maternal complications.
See related editorial, page 177
Several studies in animal models and humans have shown that a very short period of fetal anoxia could lead to irreversible cerebral lesions. To prevent hypoxic-ischemic morbidities of the neonate, nonreassuring fetal heart rate (NRFHR) monitoring during labor is one of the major indications for prompt delivery of the fetus by performing an emergency cesarean section (ECS). Studies have demonstrated that in cases of fetal distress, expressed as NRFHR, delivery within the recommended 30 minute interval resulted in improved Apgar scores and umbilical artery pH. Therefore, the 30-minute rule for decision-to-delivery interval (DDI) when ECS is performed, has become a common practice and has been adopted by many professional associations. Nevertheless, the existing scientific evidence to support these recommendations is weak. Moreover, there are reports showing that even longer DDI in ECS for NRFHR did not necessarily correlate with a poorer perinatal outcome. In addition, other investigators have shown that DDI of 30 minutes or less is not universally feasible, especially in busy obstetric units.
Despite the fact that this issue is of major importance to every obstetrician worldwide daily, there is still no consensus regarding the recommended time interval between decision to ECS. It is obvious that the ability to achieve short DDI depends on the levels of facilities of the hospitals. In the last years, efforts have been made to identify factors that may influence DDI, such as correct identification of the clinical urgency degree, communication skills between healthcare members, whether the ECS was performed within or outside standard working hours, seniority of the surgeon, cervical dilatation, type of anesthesia used, midwifery staff level, and whether the woman had a previous cesarean section (CS).
Recently, programs to shorten DDI were mainly designed in tertiary centers and focused in improving communication skills between staff members by performing simulation drills to assess and improve obstetric team performance. There is still no information regarding the effect of such programs on perinatal outcome. Therefore, the aim of the current study was to analyze the effect of a departmental program, designed to shorten DDI for ECS for NRFHR, on maternal and neonatal outcome.
Materials and Methods
The medical records of all patients who underwent ECS for NRFHR, at the labor ward of the Obstetrics and Gynecology Department, Edith Wolfson Medical Center, Holon, Israel, from Jan. 2009 to June 2013 (54 months), were reviewed retrospectively. Our labor ward has a standard intrapartum management protocol that includes: (1) The use of continous cardiotocograph monitor. (2) Interpretation of fetal monitor that follows the American College of Obstetricians and Gynecologists guidelines. (3) Decision to perform ECS is made by the senior attending physician, thus, recording the time point to start the timer for DDI. (4) Cesarean section because of NRFHR must be done as soon as possible, and it is defined as an emergent CS. (5) Clear documentation in the computerized medical notes of the decision for ECS, and the events that led to the decision, including description of the fetal heart rate changes is required.
Cases eligible for the study were identified from the labor-ward computerized data system. The study group included women who delivered, between 24-42 weeks of gestation, by ECS for NRFHR as the only indication. Those with additional indications for ECS, such as abnormal progress in labor, or maternal refusal for CS, or inadequate documentation, were excluded. Women with evidence of fetal or neonatal malformations were also excluded from the study.
From March 2011, a departmental protocol aimed to shorten DDI for ECS for NRFHR was implemented and it included: (1) documenting precise time intervals in addition to recording DDI, such as: decision-to-entering operating room (OR) interval, entering OR-to-anesthesia interval, anesthesia-to-uterine incision interval, and incision-to-delivery interval. (2) General anesthesia for patients without regional anesthesia was preferred. (3) Each case was debriefed for identification of delaying obstacles by the departmental obstetric staff, usually in the departmental morning meeting; mainly conducted by the head of the department. (4) For each case, a strategy was tailored, targeted to overcome each delaying obstacle in subsequent cases. The relevant staff members: nurses, midwives, anesthesiologists, neonatologists, and administrators, were questioned in an attempt to overcome each staff members’ share in the delay of the case.
For purposes of the study, the study population was divided into 2 groups; those delivered before (−27 months, period 1) (P1) and after (+27 months, period 2) (P2) program implementation. DDI and maternal and neonatal outcomes were compared between the 2 groups. Approval for the study was obtained from the Local Ethics Committee.
Data collection
The clinical data for the present study was collected from the patients’ medical and surgical files and included: demographic and labor characteristics: age, gravidity and parity, body mass index (kg/m 2 ), known complications during pregnancy, as pregestational diabetes mellitus (Pre-GDM), GDM, A1, and A2, thrombophilia, preeclampsia, trial of labor after cesarean delivery attempt, gestational age at delivery, oligohydramnios, defined as amniotic fluid index <5 cm, cervical dilatation at decision to perform ECS, the presence of intrapartum fever (defined as fever >38°C), and regional epidural anesthesia before the ECS. Intraoperative maternal complications included: need for general anesthesia, bleeding necessitating blood transfusions, surgical extensions >3 cm, injuries to adjacent organ. Postpartum complications included endometritis, defined as fever with abnormal uterine tenderness in the absence of other findings suggesting another source of infection, the need for blood transfusion, relaparotomy, wound infection/hematoma, pelvic abscess, and thromboembolism, and anesthesia related complications such as postdural puncture headache necessitating blood patch.
Immediately after birth, all neonates were examined by pediatricians. Birthweight and the specific percentile for gestational age were assigned using the updated Israeli growth charts. Fetal growth restriction was defined when the actual birthweight was below the 10th percentile for gestational age. The following information was collected from the neonatal medical records: Apgar scores, cord blood pH ≤7.1, sepsis (defined as positive blood or cerebrospinal fluid culture), need for blood transfusion, need for phototherapy, respiratory distress syndrome (defined as clinical signs of respiratory distress warranting treatment with oxygen, and continuous nasal pressure or mechanical ventilation, with typical radiographic appearance), need for mechanical ventilation and respiratory support, necrotizing enterocolitis, intraventricular hemorrhage, and diagnosis of hypoxic ischemic encephalopathy or seizures and death.
Statistical analysis
Data were analyzed by SPSS software, version 15.0 (SPSS Inc, Armonk, NY). Continuous variables were calculated as mean ± SD or range, as appropriate. Categoric variables were calculated as number and rate (%). Continuous parameters were compared between the groups by Student t test, and categoric variables, by χ 2 test. A P value of < .05 was considered statistically significant.
Intraoperative maternal composite outcome was defined as one or more of the following intraoperative complications: surgical extensions >3 cm, intraoperative bleeding necessitating blood transfusion, injury to adjacent organ. Postpartum maternal composite outcome was defined as one or more of the following complications: endometritis, pelvic abscess, blood transfusion, wound infection/hematoma, relaparotomy, postdural puncture headache, or thromboembolism.
Neonatal composite outcome was defined as one or more of the following complications: sepsis, blood transfusion, phototherapy, respiratory distress, mechanical ventilation, respiratory support, intraventricular hemorrhage, seizures, hypoxic-ischemic encephalopathy, or death.
To identify independent risk factors for adverse neonatal outcome, a multivariate stepwise forward logistic regression analysis was performed. Parity, gestational age, general anesthesia, preeclampsia, Pre-GDM, GDM, thrombophilia, intrapartum fever, birthweight, DDI, and time periods P1 and P2 (defined as the time period before and after implementation of the protocol), served as independent variables.
To identify independent risk factors for shorter DDI, a linear multivariate regression model was performed, with DDI as a dependent variable, and general anesthesia, spinal anesthesia and time periods P1 and P2 served as independent variables.
Results
During the 54 months study time period, a total of 20, 366 women delivered, among them 4507 (22.1%) underwent cesarean sections. Of them, 738 ECS were performed because of NRFHR (16.4%). Of them, 145 ECS were excluded; 131 because the association of NRFHR was accompanied by abnormal progress in labor, 6 because of maternal refusal for CS, and 8 because of incomplete data. Of the 593 ECS analyzed, 292 were performed before (P1) and 301 were performed after (P2) implementation of the departmental protocol.
The rate of category 2 FHR tracing before decision for ECS was similar in P1 vs P2, 92.1% vs 92.3%, respectively, P = .91, as well as the rate of category 3 tracing in P1 vs P2, 7.9% vs 7.7%, respectively, P = .91.
Table 1 presents maternal and delivery characteristics of the groups before (P1) and after (P2) protocol was implemented. There were no differences in maternal age, gravidity, parity, body mass index, rate of fetal growth restriction, diabetes mellitus, preterm labor <34 weeks, multiple pregnancy, oligohydramnios, intrapartum fever, epidural anesthesia, trial of labor after cesarean delivery attempts, and number of patients in active labor, between the groups. Preeclampsia was more common in P1 compared with P2, 11.3% vs 6.6%, respectively, P = .047. General anesthesia was performed more often in P2 than in P1, 46.2% vs 24%, respectively, P < .001, spinal anesthesia was performed more often in P1 than in P2, 27% vs 11.3%, respectively, P < .001.
| Characteristic | P1 n = 292 | P2 n = 301 | P value |
|---|---|---|---|
| Mean gestational age, wks | 38.9 ± 2.5 | 39.1 ± 2.2 | .225 |
| Gravidity | 2.16 ± 1.6 | 2.14 ± 1.3 | .821 |
| Parity | 0.8 ± 1.2 | 0.7 ± 1 | .164 |
| BMI, kg/m 2 | 24.2 ± 5.8 | 24.1 ± 5.1 | .990 |
| Diabetes mellitus | 19 (6.5) | 15 (5) | .425 |
| Preeclampsia | 33 (11.3) | 20 (6.6) | .047 |
| Oligohydramnions | 17 (5.8) | 19 (6.3) | .803 |
| Thrombophilia | 4 (1.4) | 4 (1.3) | .966 |
| TOLAC attempts | 30 (10.3) | 29 (9.6) | .79 |
| Patient in active labor | 141 (48.3) | 167 (54.2) | .080 |
| FGR <10th percentile | 67 (22.9) | 54 (17.9) | .131 |
| FGR <3rd percentile | 23 (7.9) | 23 (7.6) | .915 |
| Preterm labor <34 wks | 14 (4.8) | 13 (4.3) | .781 |
| Intrapartum fever >38 ° C | 11 (3.8) | 15 (5) | .464 |
| Multiple pregnancies | 5 (1.7) | 3 (1) | .450 |
| Epidural anesthesia | 143 (49) | 128 (42.5) | .115 |
| General anesthesia | 70 (24) | 139 (46.2) | < .001 |
| Spinal anesthesia | 79 (27) | 34 (11.3) | < .001 |
Mean DDI significantly decreased in P2 compared with P1, 12.3 ± 3.8 minutes vs 21.7 ± 9.1 minutes, respectively, P < .001. Overall, 299 (99.3%) of the operations in P2 were performed within DDI <30 minutes, compared with 241 (82.5%) in P1, P < .001. The rate of ECS within DDI <20 minutes was also significantly higher in P2 group compared with P1 group, 93.7% vs 56.8%, respectively, P < .001. Mean surgery duration (from incision to skin-closure) did not differ between the groups, 35.3 ± 11.8 minutes vs 34.6 ± 18.9 minutes, P = .609 ( Table 2 ). In a linear multivariate regression model for DDI as a dependent variable, and general anesthesia, spinal anesthesia and period of the study (P1 and P2) as independent variables, P2 ( P < .001) and general anesthesia ( P = .013) were significantly independent predictors for shorter DDI by stepwise analysis, R 2 = 0.345 P < .001. Spinal anesthesia was found as independent predictor for longer DDI, P < .001.
| Variable | P1 n = 292 | P2 n = 301 | P value |
|---|---|---|---|
| Mean DDI, min | 21.7 ± 9.1 (7–62) | 12.3 ± 3.8 (5–30) | < .001 |
| ECS within DDI <30 min | 241 (82.5) | 299 (99.3) | < .001 |
| ECS within DDI <20 min | 166 (56.8) | 282 (93.7) | < .001 |
| Mean surgery duration, min | 35.3 ± 11.8 (18–105) | 34.6 ± 18.9 (16–120) | .609 |
Composite maternal outcome (intraoperative and postoperative) and mean maternal hospitalization time did not differ between the groups ( Table 3 ).
| Variable | P1 n = 292 | P2 n = 301 | P value |
|---|---|---|---|
| Maternal hospitalization time, d | 4.7 ± 1.5 | 4.3 ± 1.3 | .646 |
| Intraoperative complications | |||
| Surgical extensions >3 cm | 34 (11.6) | 31 (10.3) | .694 |
| Intraoperative bleeding necessitating blood transfusions | 4 (1.4) | 3 (1) | .072 |
| Injuries to adjacent organ | 1 (0.4) | 1 (0.3) | > .99 |
| Composite intraoperative complications | 39 (13.4) | 35 (11.6) | .537 |
| Postoperative complications | |||
| Endometritis | 10 (3.4) | 9 (3) | .819 |
| Pelvic abscess | 1 (0.4) | 0 | .492 |
| Anemia necessitating blood transfusions | 5 (1.7) | 4 (1.3) | .749 |
| Wound infection/hematoma | 15 (5.1) | 9 (3) | .214 |
| Relaparotomy | 2 (0.7) | 2 (0.7) | > .99 |
| PDPH | 8 (2.8) | 5 (1.7) | .413 |
| Composite postoperative complications | 41 (14) | 29 (9.6) | .099 |
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