As per the latest report of the Registrar General of India, Maternal Mortality Ratio of India has declined from 212 per 100,000 live births in the period 2007-09 to 130 per 100,000 live births [1]. Reducing Maternal mortality and improving existing health care is a prime concern both for the country and worldwide.
Both, Maternal mortality and Maternal near miss are important indicators of maternal health. Maternal mortality, is often described as “the tip of the iceberg” [2], and maternal morbidity as the base. That is for each maternal death, there are several women who experienced a severe complication, nearly died but survived (near miss) [3].
There are several advantages of using SAMM as a tool compared to maternal mortality, e.g., - the woman is alive to give a detailed account of the series of the event, there are more number of cases of SAMM compared to maternal deaths. The health personnel are more forthcoming in giving detailed treatment information as there is no threat of punitive liability [5]. Hence, over the last decade; there is a gaining momentum to use MNM as an indicator of obstetric care, even in developing countries [5,6].
However, unlike maternal deaths, it often becomes difficult to define MNM cases. With passage of time and geographical boundaries, the definition of near miss has evolved and literature demonstrates different criteria being used to define near miss (disease specific, management specific, organ system dysfunction specific, WHO criteria [7] etc.,). Ministry of Health and Family Welfare (MOHFW), India, have recently laid down Operational guidelines [4] to define and report MNM cases, adapted for and use in the country. Being a relatively new guideline, there is paucity of well-designed, prospective studies using it to Audit Near Miss.
Hence, this study was conducted, to identify gaps in the existing Health system in India and determine an approach to resolve them using the MNM review Operational guidelines, launched by MOHFW, India.
This study, also aimed to determine the incidence of MNM to Maternal Mortality Ratio (MNRM) and the Mortality Index (MI) in a tertiary care hospital, over a period of one year according to the Maternal Near Miss operational Guidelines, laid by MOHFW, Government of India.
Materials and Methods
A prospective cohort study was conducted in a Tertiary care hospital, in North India from October 2015 to December 2016, to determine the causes of MNM.
The cases which met the criteria of MNM as per the Maternal Near Miss Operational Guidelines, [4] were included for audit by the Maternal mortality review committee along with maternal death cases. The Institutional Ethical Committee approved the study (IEC/VMMC/ SH/Thesis/October/2015). All the participants signed the consent form (Hindi or English).
Inclusion Criteria
During the study period, all the women who met the criteria for MNM were identified at the time of discharge and enrolled in the study. Maternal mortality cases were identified as per WHO definition of maternal death [8] from amongst all the female deaths in the hospital.
Facility based MNM Review form and Facility based maternal death form were filled for MNM cases and maternal deaths, respectively by the treating doctors. Patient characteristics including age, parity, gestational age at the time of admission, booked (at least 3 antenatal visits at the institute), mode of delivery, ICU admission, lifesaving intervention and foetal outcome were analysed for both the groups. Caregivers were interviewed and medical records reviewed to identify the gaps in both the groups by the members of the departmental committee members. In some near miss cases, women were also interviewed. Audit was conducted for both by the departmental committee, during the weekly and monthly meet.
Patients were categorised by final diagnosis with respect to haemorrhage, hypertension, sepsis, dystocia (direct causes). Anemia, thrombocytopenia, and other medical disorders were considered as indirect causes contributing to MNM and deaths.
The above data was analysed to calculate the following near miss indices [9]:
Women with Life-Threatening Conditions (WLTC) refers to all women who either qualified as maternal near-miss cases or those who died (i.e., women presenting a severe maternal outcome). It is the sum of maternal near-miss and maternal deaths (WLTC=MNM+MD).
Severe Maternal Outcome Ratio (sMOR) refers to the number of women with life-threatening conditions (MNM+MD) per 1000 live births (LB). {SMOR=(MNM+MD)/LB}.
MNM Ratio (MNMR) refers to the number of maternal near-miss cases per 1000 live births (MNMR=MNM/LB).
Maternal Near-Miss Mortality Ratio (MNM: MD) refers to the ratio between MNM cases and Maternal Deaths (MD).
Mortality Index (MI) refers to the number of maternal deaths divided by the number of women with life-threatening conditions expressed as a percentage [MI=MD/(MNM+MD)].
Statistical Analysis
Data entry was done on Microsoft Excel spreadsheet and it was analysed using Statistical Package for Social Sciences (SPSS) version 21.0. For qualitative data, proportions were calculated. Mean score was calculated for quantitative data. Test of significance of differences between proportions and mean were calculated. Qualitative data was analysed by Chi-square test and t-test was applied for quantitative data. p-value <0.05 was considered significant.
Results
During the study period, there were 31,925 deliveries at the Institute. Total live births, maternal mortality and near miss cases are shown in [Table/Fig-1].
Indices | Numbers |
---|
Total no. of deliveries | 31,925 |
Total no. of live births (LB) | 31,111 |
Number of near miss cases (MNM) | 249 |
Number of maternal mortality cases (MM) | 131 |
Maternal near miss incidence ratio (MNM IR=MNM/LB) | 8/1000 live births (0.8%) |
Maternal mortality ratio (MMR=MM/LB) | 421/1,00,000 live births (0.421%) |
Maternal near miss: Maternal mortality ratio (MNM: MD) | 1.9:1 |
Mortality index (MD/MNM+MD) | 34.0% |
Severe maternal outcome ratio (SMOR=MNM+MD/LB) | 12.2/1000 live births (1.22%) |
[Table/Fig-2] shows the characteristics of women in both the groups. Mean age of the women in both the groups were comparable, majority of the women were in their twenties. More number of women with teenage pregnancies died than survived (12.2% versus 5.6%). Most of the women were unbooked. Many women had more than one level of delay. Delay in women seeking care (level 1) was most common in both the groups. A high proportion of women also experienced a delay in referrals to the current Health facility (Level 3 delay), 70% and 74.8%, respectively. More number of women in the maternal death group (34.3% versus 27.7%) presented to the hospital with postpartum complications, however, the difference was not statistically significant. Many had undergone LSCS at another health facility and referred with multiple complications to the present facility (27.5% and 37.8%, in MNM and MM group, respectively).
Patient characteristics | Near miss (249) | Maternal deaths (131) | p-value |
---|
Age (years) | 26.55±4.16 years | 26.02±5.05 years | 0.29 |
≤20 yrs | 14 (5.6%) | 16 (12.2%) |
21-25 yrs | 93 (37.3%) | 52 (39.7%) |
26-30 yrs | 111 (44.6%) | 44 (33.6%) |
31-35 yrs | 22 (8.8%) | 14 (10.6%) |
≥35 yrs | 9 (3.6%) | 5 (3.8%) |
Parity |
Primipara | 77 (30.9%) | 43 (32.8%) | 0.07 |
Multipara | 172 (69%) | 88 (67.1%) |
Antenatal/Postnatal status |
Antenatal | 180 (72.3%) | 86 (65.6%) | 0.179 |
Postnatal | 69 (27.7%) | 45 (34.3%) |
LSCS done at another facility and referred | 27.5% | 37.8% |
Mean duration of hospital stay | 8.94±3.06 days | 3.27±6.9 days | <0.01 |
Antenatal care |
Booked | 22 (8.8%) | 8 (6.1%) | 0.35 |
Unbooked | 227 (91.2%) | 123 (93.9%) |
Referral status |
Referred | 178 (71.4%) | 98 (74.8%) | 0.49 |
Self admitted | 71 (28.5%) | 33 (25.2%) |
ICU admission | 159 (63.9%) | 90 (68.7%) | 0.34 |
Not admitted in ICU | 90 (36.1%) | 41 (31.2%) |
Period of Gestation (POG) in weeks |
<12 | 23 (12.8%) | 1 (1.2%) | 0.002 |
12-28 | 15 (8.3%) | 14 (16.3%) |
>28 | 142 (78.9%) | 71 (82.6%) |
Socioeconomic status (Modified Kuppuswamy scale) |
Lower middle | 58 (23.3%) | 14 (10.7%) | <0.0001 |
Upper lower | 16 (6.4%) | 0 |
Lower | 175 (70.9%) | 117 (89.3%) |
Level of delay |
First delay | 169 (67.9%) | 102 (77.9%) | <0.01 |
2nd delay | 33 (13.3%) | 5 (3.8%) |
3rd delay | 175 (70.0%) | 98 (74.8%) |
Educational status |
Illiterate | 184 (73.9%) | 120 (91.6%) | <0.01 |
Literate | 65 (26.1%) | 11 (8.4%) |
A high proportion of women in MNM group had live births (61.8%) compared to MM group (38.9%, p-value <0.001). However, the incidence of Intra-uterine fetal deaths were comparable in both groups (23.4% vs 29.0%).
Most common causes of MNM in the study were haemorrhage (53.8%) [Table/Fig-3]. Majority of Maternal deaths were due to direct causes (71.8%). The most common causes were hypertensive disorders of pregnancy (31.2%). In the MNM group, admission to ICU was the most common intervention (63.9%), [Table/Fig-4,5 and 6].
Distribution of study participants according to primary cause in Maternal Near miss group.
Primary determinant | Maternal near miss (n=249) |
---|
Haemorrhage | 134 (53.8%) |
Early pregnancy | 27 (10.8%) |
Abortion | 4 (1.6%) |
Ectopic pregnancy | 23 (9.2%) |
Late pregnancy | 107 (43%) |
APH | 19 (7.6%) |
Placenta previa | 12 (4.8%) |
abruption | 7 (2.8%) |
PPH | 53 (21.3%) |
Atonic PPH | 45 (18%) |
Traumatic PPH | 8 (3.2%) |
Morbidly adherent placenta | 13 (5.2%) |
Rupture uterus | 16 (6.4%) |
Uterine inversion | 6 (2.4%) |
Hypertensive disorders in pregnancy | 54 (21.7%) |
Ecclampsia | 33 (13.2%) |
Pre-ecclampsia | 21 (8.4%) |
Obstetrical sepsis | 22 (8.8%) |
Postabortal | 5 (2%) |
Puerperal sepsis | 17 (6.8%) |
Medical disorder | 32 (13.3%) |
Cardiac dysfunction | 9 (3.6%) |
Haematological dysfunction | 19 (7.6%) |
Hepatic dysfunction | 1 (0.4%) |
Respiratory dysfunction | 1 (0.4%) |
Endocrine dysfunction | 2 (0.8%) |
Incidental/accidental causes | 7 (2.8%) |
Infections | 6 (2.4%) |
Anaphylaxis | 1 (0.4%) |
Cause of maternal mortality according to International Classification of Disease 10th revision (ICD-10 & ICD-MM).
Direct causes | Maternal mortality (n=131) |
---|
Pregnancy with abortive outcome | 8 (6.1%) |
Ectopic pregnancy | 1 (0.8%) |
Septic abortion | 7 (5.3%) |
II. Hypertensive disorders | 41 (31.2%) |
Eclampsia | 20 (15.2%) |
Severe PE/HELLP | 21 (16%) |
III. Obstetrical haemorrhage | 25 (19%) |
APH | 8 (6.1%) |
PPH | 14 (10.7%) |
Rupture uterus | 3 (2.3%) |
IV. Pregnancy related infections | 19 (14.5%) |
Chorioamnitis | 1 (0.8%) |
Wound infections | 3 (2.3%) |
Puerperal sepsis | 15 (11.5%) |
V. Other obstetric complications | 1 (0.8%) |
Amniotic fluid embolism | 1 (0.8%) |
VI. Unanticipated complications of management | 0 (0.0%) |
VII. Non obstetric complications | 37 (28.2%) |
Cardiovascular causes | 8 (6.1%) |
Haematological causes | 8 (6.1%) |
Hepatic disorders | 10 (7.6%) |
Neurological disorders | 1 (0.8%) |
Respiratory disorders | 4 (3.0%) |
Renal disorders | 0 (0.0%) |
Maternal infections and parasitic disease | 6 (4.6%) |
VIII Unknown | 0 (0.0%) |
IX Coincidental causes | 0 (0.0%) |
Disease specific mortality index.
Cause | Total | MNM | MM | Mortality index MI (%) |
---|
Haemorrhage | 160 | 134 (83.8%) | 26 (16.3%) | 16.3 |
Early pregnancy | | 27 | 1 |
Late pregnancy | | 107 | 25 |
APH | | 19 | 8 |
PPH | | 53 | 14 |
Rupture Uterus | | 16 | 3 |
Uterine Inversion | | 9 | - |
Morbidly adherent placenta | | 13 | - |
Hypertension | 95 | 54 (56.8%) | 41 (43.2%) | 43.2 |
Eclampsia | | 33 | 20 |
Pre-eclampsia | | 21 | 21 |
Medical disorders (indirect cause) | 69 | 32 (46.4%) | 37 (53.6%) | 53.6 |
Obstetrical sepsis | 48 | 22 (45.8%) | 26 (54.2%) | 54.2 |
Others | 8 | 7 (87.5%) | 1 (12.5%) | 12.5 |
Critical lifesaving interventions done in Maternal near miss and maternal mortality group.
Interventions | Maternal near miss (n=249) | Maternal mortality (n=131) |
---|
ICU admission | 159 (63.9%) | 90 (68.7%) |
Resuscitative procedure/intubation | 59 (23.7%) | 98 (74.8%) |
Mechanical ventilation | 14 (5.6%) | 25 (19.1%) |
Use of cardiotonics/vasopressors | 33 (13.3%) | 64 (48.9%) |
Laparotomy with B lynch suture | 1 (0.4%) | 1 (0.8%) |
Hysterectomy | 44 (17.3%) | 12 (9.2%) |
Internal iliac artery ligation | 5 (2%) | 5 (3.8%) |
Repair of genital injuries | 10 (4%) | 0 (0%) |
Manual removal of placenta | 1 (0.4%) | 0 (0%) |
Reposition of inverted uterus | 6 (2.4%) | 0 (0%) |
Balloon tamponade | 14 (5.6%) | 5 (3.8%) |
Evacuation | 6 (2%) | 0 (0%) |
Repair of bowel, bladder | 5 (2%) | 0 (0%) |
Dialysis | 14 (5.6%) | 5 (3.8%) |
Management of ketoacidosis | 2 (0.8%) | 2 (1.5%) |
Drugs to reduce cerebral oedema (mannitol) | 2 (0.8%) | 5 (3.8%) |
Blood transfusions | 78 (31.3%) | 42 (32.1%) |
Discussion
Over the last decade; there is a gaining momentum to use MNM as an indicator of obstetric care. Several studies have been conducted to audit the MNM cases [10-27] both in India and across the globe. However, unlike maternal death, identifying MNM is complex. Different criteria have been used in the past to define MNM, like disease specific criteria, management specific criteria or organ system dysfunction criteria. WHO have defined near miss using organ system dysfunction criterion. While, many authors have used the WHO Criteria for near miss audit [Table/Fig-7], some had to make minor changes to this approach [14,16,23, 24] as the need was felt to modify according to the lack of some facilities at their centre or an underestimation of near miss cases was perceived using this approach.
Study and year | Study design | Setting/Total no. of deliveries | Criteria | MNM incidence ratio | MNM: mortality ratio | Mortality index | Most common cause (MNM) | Most common cause (MD) | Highest mortality index |
---|
Almerie Y et al., 2010 [11] | Retrospective | Damascus, Syria/ 28,025 deliveries | Disease specific (Flippi 2005) | 32.9/1000 live births | 60:1 | 0.02 | Hypertensive disorders (52%) | Late pregnancy haemorrhage (60%) | Sepsis (7.4%) |
Ali AA et al., 2011 [13] | Retrospective | Sudan/ 9,578 deliveries | Disease specific (Flippi 2005) | 22.1/1000 live births | 1.5:1 | 0.20 | Haemorrhage (40.8%) | - | Infection (22.2%) |
Roopa PS 2013 [10] | Audit | Manipal, India/ 7390 deliveries | WHO Near Miss Approach | 17.8/1000 live births | 5.6:1 | 0.15 | Haemorrhage (44.2%) | Sepsis ((52.2%) | Cardiac disease (40%), Sepsis (36.3%) |
Purandre CN et al., 2014 [2] | Prospective | Multicenter, India/27,433 deliveries | Guidelines from MOHF & W, Govt. of India, Dec 2014 | 9.623/1000 deliveries | - | - | Haemorrhage (46.9%) | - | - |
Gupta S et al., 2015 [17] | Prospective | New Delhi, India/ 6,892 deliveries | WHO Near Miss Approach | 3.98/1000 live births | 3.37:1 | 0.228 | Haemorrhage | Hypertensive disorders of pregnancy (37.5%) | - |
Bansal M et al., 2016 [12] | Retrospective | Chhattisgarh, India/ 3,539 deliveries | WHO Near Miss Approach | 11.9/1000 live births | 2.05:1 | 0.33 | Haemorrhage (43.5%) | Pre-ecclampsia/ecclampsia (31.57%) | - |
Kalisa R et al., 2016 [23] | Prospective cohort | Rwanda, 3979 deliveries | WHO Near Miss Approach (Pa o2/fi)2, pH, Lactate, Dialysis for Acute renal Failure not available) | 21.5/1000 live births | 6.62:1 | 0.131 | Haemorrhage (57%) | Ecclampsia (30.7%) | Sepsis/Peritonitis following cesarian (33.3%) |
Rathod AD et al., 2016 [14] | Retrospective cohort | Yavatmal, India/ 21,992 deliveries | WHO Near Miss Approach (SOFA Score) | 7.56/1000 live births | 3.43:1 | 0.29 | Haemorrhage (26.7%) | Hypertensive disorders (27.27%) | Cardiac dysfunction (68.42%) |
Parmar TN et al., 2016 [24] | Cross-sectional study | Vadodra, Gujarat, India/ 2,104 deliveries | WHO Near Miss Approach and Mantel et al., criteria | 23.85/1000 live births | 2.6:1 | 0.281 | - | - | - |
Tallapureddy S et al., 2017 [15] | Retrospective | Tirupati, Andhra Pradesh, India | WHO Near Miss Approach | 8.4/1000 live births | 5.3:1 | 0.158 | Haemorrhage (43.7%) | Hypertensive disorders (66.6%) | - |
Herklots T et al., 2019 [16] | Prospective | Zanzibar, East Africa/ 22,054 deliveries | WHO Near Miss Approach (with local adaptation e.g., dialysis facility unavailable, blood transfusion >=5 included blood/ blood component therapy and women were included if they needed but could not get due to non availability etc.) | 11.6/1000 live births | 3.2:1 | 0.24 | Hematological dysfunction | Cardiovascular or Respiratory dysfunction | - |
Samant PY et al., 2019 [25] | Retrospective-prospective | Maharashtra, India | WHO Near Miss Approach | 112.57/1000 live births | 14.28:1 | - | Severe pre-ecclampsia (51%) | - | - |
Kamal s et al., 2019 [26] | Descriptive | Jharkand, India/ 20,000 deliveries | WHO Near Miss Approach | 24/1000 live births | 7.2:1 | - | Haemorrhage (42.5%) | - | - |
Kumari S et al., (Current study) | Prospective cohort | New Delhi, india/ 31,925 deliveries | Guidelines from MOHF & W, Govt. of India, Dec 2014 | 8/1000 live births (0.8%) | 1.9:1 | 0.34 | Haemorrhage (53.8%) | Hypertensive disorders of pregnancy (31.2%). | Obsterical sepsis (54.2 %)Medical disorders (53.6%) |
Moreover, many previous studies are retrospective [11-15] or have a small sample size [10,12,17,23,24], making it difficult to arrive at a statistically powered conclusion. This study aimed to determine the incidence of MNM cases as defined in Maternal Near Miss Review Operational Guidelines, released by the MOHFW, Government of India in 2014 [4]. For identification of an MNM case according to this criterion (minimum three, one from each category) must be present:
Clinical findings (either symptoms or signs), Investigations, Interventions or any single criteria which signifies cardio respiratory collapse from different categories of various adverse events and disorders associated with them. Very few Indian studies have used the MOHFW criteria for MNM [10] to audit these cases.
The strength of the current study is that it has a large sample size, is prospective and is well-designed, also comparing the socio-demographic profile of MNM cases with maternal deaths. Roopa PS et al., [10], was a multi-centric, pilot study using the Operational guidelines by MOHFW [4], however, no comparison was made with maternal mortality cases.
The MNM Incidence Ratio in this study (0.8%) was lowest except for Gupta S et al., [Table/Fig-7] [17]. This difference can be explained due to different settings in which the studies were conducted. The latter caters to a selected population of medically insured patients who are often booked and the hospital is not open to general public. While the hospital in the current study is a tertiary care centre, receiving unbooked and complicated cases from across the state and the neighbouring states. Disease specific criterion as used by some studies [11,13], is known to report a higher no. of cases as near miss. Many studies have used the WHO criterion [9] or their modifications [Table/Fig-7] which may explain the difference in the incidence ratio. WHO criterion is organ system dysfunction based, while, the Indian guidelines incorporates all the 3 criterion; disease based, management based and organ system dysfunction based (1 from each category is required to label as near miss, unless there is evidence of cardiovascular collapse).
The low MNM/MD ratio in this study [Table/Fig-7], may be wrongly interpreted as a poor quality of care, but it actually is due to strict adherence to Indian guidelines and also, most of these patients were unbooked (91.2-93.9%) and referred (71.4-74.8%) to the centre after multiple complications.
In spite of the heterogeneity in the study design and the setting, most of the studies like the current study have reported haemorrhage followed by hypertensive disorders as the most common cause of MNM, while hypertensive disorders was the leading cause of maternal deaths [Table/Fig-7]. Even studies from developed countries like Australia and Netherlands have reported obstetric haemorrhage as the most frequent cause of severe acute maternal morbidity [20,21].
A detailed analysis of women in haemorrhage group reveals that most of the critically bleeding women were in the postpartum phase with PPH (39.3%). This observation is similar to other Indian studies by Roopa PS et al., and an Australian study by Jayaratnam S et al., which have also observed PPH as the most common cause of MNM [10,20].
In the hypertensive group, there were higher proportion of eclampsia versus pre-eclampsia (13.2 and 8.4%, respectively), hence reaffirming that timely initiation of magnesium sulphate therapy and termination of pregnancy can salvage these women.
Obstetrical sepsis (54.2%) and medical disorders like cardiac disease (53.6%), continue to pose a major threat to the health of the women. They have the highest mortality index [Table/Fig-5] also reported in other studies [Table/Fig-7]. Puerperal sepsis was most common (6.8%) cause of sepsis. This is in spite, of launch of Janani Suraksha Yojana (JSY), a cash incentive scheme launched by the Government of India to promote institutional deliveries [7,28]. Though there has been an increase in the institutional deliveries to 84.44% as per the recent National Family Health Survey-4 (NFHS 4 2015-16) in Delhi state, the increased load to health facility may compromise the quality of care due to limited infrastructure or trained health personnel [29].
Indirect causes (medical disorders) too pose a major challenge to the health of the women. A multi-disciplinary approach and timely detection and referral of the high risk women to a tertiary care centre, through good quality antenatal coverage and referral linkage, may help optimise the health of these women.
In this study, a significant association was demonstrated with lower socioeconomic status and illiteracy and occurrence of maternal mortality, (p<0.0001, p<0.01, respectively). Also, the most common delay identified were type 1 delay (delay in the decision to seek care; 67.9-77.9%) and type 2 delay (delay arrival at the health facility;70-74.8%) [26]. Thus, highlighting the role of social factors and cost in a women’s health and how education may play a role in changing attitudes and promoting a health seeking behaviour.
Limitation(s)
The interview of all the maternal near cases and verbal autopsy for maternal death cases could not be done.
Conclusion(s)
The MNM IR in this study was 8/1000 live births and the MMR was 421/100,000 live births. The MNM: MM ratio was 1.9:1. Overall Mortality Index (MI) was 34%. Severe Maternal Outcome Ratio (SMOR) was 12.2/1000 live births. The most common cause of MNM was haemorrhage, mostly, post-partum haemorrhage. Lower socio-economic status and illiteracy were associated with occurrence of maternal mortality. The most common cause of maternal deaths were hypertensive disorders of pregnancy. Hence, from the present study it is concluded, that mothers may benefit by upgradation of the infrastructure of the peripheral health centres (like ensuring availability of blood banks, round the clock operation theatre facility, magnesium sulphate for seizure prophylaxis etc.) along with a network of referral linkage to ensure speedy and appropriate referrals. Inspite of a high percentage of institutional delivery, obstetrical sepsis and medical disorders continue to challenge the health system as they have the highest mortality index.