A prospective, facility-based, cross sectional study was conducted from 22 June to 22 December in 2017 in Zahedan, Iran. Sistan and Baluchistan province has a population size of 2.775 million distributed over a land area of 180726 km2. Zahedan, the capital of the province, entails three hospitals, one of which is Ali-ibn Abi Talib. This center is the only provincial tertiary teaching hospital with a catchment population of about 2221544 people. This hospital also receives referrals from the other two tertiary hospitals in the same city, other district hospitals, health centers, and rural and urban childbirth facilities, as well as self-referring patients. Therefore, Ali-ibn Abi Talib Hospital, as a representative of childbirth facilities, affiliated to Zahedan University of Medical Sciences.
Annually, almost 7000 deliveries are conducted in this hospital. During the study period, the medical staff consisted of 10 obstetricians and 34 midwives. Additionally, midwifery and medical students, as well as obstetrics and gynecology residents provide care for parturient mothers. Mothers and newborns are referred to this hospital in case of the development of any medical/surgical complications or the emergence of unpredicted intrapartum and postpartum complications. Anesthesiologists, obstetricians, and pediatricians are present in the hospital 24 hours a day. This referral hospital is equipped with two intensive care units (ICUs) of 12 beds.
The study population corresponded to all females giving birth at Ali-ibn Abi Talib Hospital or referred to this hospital for childbirth, as well as the ones within 42 days of pregnancy termination. All subjects were females with a gestational age of over 22 weeks. The females diagnosed with abortion or ectopic pregnancy was excluded since the denominator for both abortion and ectopic pregnancy rates was not reliably known.
Females with PLTC were identified based on severe complications (e.g. severe postpartum hemorrhage, severe preeclampsia, eclampsia, sepsis or severe systematic infection, and ruptured uterus) (
7).
Furthermore, the organ-system dysfunction based criteria were used to identify MNM cases (
3,
8,
10). According to this approach, an MNM case has one or more specified organ dysfunctions among the following markers: (1) cardiovascular dysfunction (shock, cardiac arrest (absence of pulse/ heart beat and loss of consciousness), continuous consumption of vasoactive drugs, cardiopulmonary resuscitation, severe hypoperfusion (lactate > 5 mM/L or > 45 mg/dL), severe acidosis (pH < 7.1); (2) respiratory dysfunction (acute cyanosis, gasping, severe tachypnea (respiratory rate (RR) > 40 breath per minute (BPM), severe bradypnea (RR < 6 BPM), intubation and ventilation not related to anesthesia, severe hypoxemia (O
2 saturation < 90% for ≥ 60 minutes or PAO
2/FiO
2 < 200); (3) renal dysfunction (oliguria non-responsive to fluids or diuretics, dialysis for acute renal failure, severe acute azotemia (creatinine ≥ 300 μM/mL or ≥ 3.5 mg/dL); (4) coagulation/hematological dysfunction (failure to form clots, massive transfusion of blood or red cells ≥ 5 U), severe acute thrombocytopenia (< 50000 platelet/mL); (5) hepatic dysfunction (jaundice in the presence of pre-eclampsia, severe acute hyperbilirubinemia (bilirubin > 100 μM/L or > 6.0 mg/dL); (6) neurological dysfunction (prolonged unconsciousness (lasting ≥ 12 hours), coma (including metabolic coma), stroke, uncontrollable fits/status epilepticus, total paralysis); and (7) uterine dysfunction (uterine hemorrhage or infection leading to hysterectomy) (
7,
8). The current study employed clinical organ dysfunction, laboratory markers of organ dysfunction, and management-based proxies to identify severe organ dysfunction (
7,
13).
The MNM and death cases (SMO cases) were categorized into two groups, one of which included the females that already met the MNM criteria on admission (i.e. referred from other childbirth facilities, and the number of live births as denominator was unclear), and the other one entailed the ones that gave birth at Ali-ibn Abi Talib Hospital and developed SMO after admission (i.e. near miss cases occurred during childbirth or within 42 days of pregnancy termination). Later, they were categorized as “referred from other childbirth facilities” (to show the rate and effectiveness of the emergency referrals) and “gave birth at Ali-ibn Abi Talib Hospital”.
Data were collected through daily visits of obstetrics ward and other relevant facilities (e.g. ICU, cardiac care unit, internal medicine, and neurological unit). During the daily visits, the females’ medical records were screened for the inclusion criteria, and cases with MNM were followed up until 42 days postpartum. For all females (including near miss cases), the data were extracted from hospital medical records, and then collected into a form adapted from the WHO MNM forms. The WHO maternal near-miss criteria were previously validated (
9,
10).
All data were transferred into SPSS version 16, and a copy of MNM records was prepared for the subsequent follow-ups, as well as for the substantiation of data accuracy. After entering the data into the software, they were checked for the accuracy by the research team. Moreover, all the cases with MNM were entered into an online system called “IMAN”. Then, these cases were checked by an expert at Iranian Ministry of Health and Medical Education, and the accuracy was verified. Additionally, information related to the patients’ demographic characteristics, hospital admission, duration of hospital stay, as well as maternal and perinatal outcomes (to monitor the performance and quality of obstetric services in the hospital itself) (
8) was recorded for all participants.
The current study protocol was approved by the Ethics Committee of Zahedan University of Medical Sciences (ZAUMS), Zahedan, Iran (July 9, 2017; IR.AUMS.REC: 1396. 82). In addition, permission was obtained from the managers of Ali-ibn Abi Talib Hospital.
The data were analyzed with SPSS version 16. The results were presented as frequencies and percentages (for categorical variables), as well as mean and standard deviations (for continuous variables). Chi-square test was used to compare demographic qualitative variables among the three groups [(1) The females that already met the MNM criteria on admission (i.e. referred from other childbirth facilities), (2) Mothers that gave birth at Ali-ibn Abi Talib Hospital and developed SMO after admission (i.e. near miss manifestations occurred during childbirth or within 42 days of pregnancy termination, (3) Females without MNM], and two-tailed tests were run to compare the variables. P-values < 0.05 were considered statistically significant.
The results were presented in accordance with WHO criteria regarding MNM 8. The MNM ratio (MNMR) refers to the number of MNM cases per 1000 live births (MNMR = MNM/LB). The SMO ratio was also obtained by inspecting the number of females with life-threatening conditions (i.e. MNM + MD) per 1000 live births. Moreover, mortality index (MI%) was calculated as MD/(MNM + MD) × 100. Hospital access indicators were also estimated by the calculation of SMO12 [cases presenting the organ dysfunction or maternal death within 12 hours of hospital stay (SMO12) (number), proportion of SMO12 cases among all SMO cases, proportion of SMO12 cases coming from other health facilities, and SMO12 mortality index: The number of SMO12 cases divided by the number of all SMO cases was expressed as a percentage].
Logistic regression model was used to estimate the association between SMO (0 = without SMO, 1 = SMO) and independent variables (type of delivery, age, parity, maternal education, place of residence, insurance coverage, history of CS, and anemia). All independent variables were considered categorical (dichotomous).
The forward stepwise method was adopted in logistic regression to study the role of each independent variable on SMO event among females with previous CS. P-value of 0.05 was selected to allow a variable to enter the model or retain a variable (as an independent variable) in the model. The overall goodness-of-fit was tested by the Hosmer-Lemeshow test and likelihood statistics. The two-tailed tests were also employed to compare the variables between groups. P-values < 0.05 were considered statistically significant.