Tranexamic acid to reduce blood loss in women at high risk of postpartum hemorrhage undergoing cesarean delivery-a randomized controlled trial.

BACKGROUND: Postpartum hemorrhage is a leading cause of maternal morbidity and mortality. Tranexamic acid has proven to be useful in treating hemorrhage from acute blood loss. However, its role in preventing blood loss in women at high risk of postpartum hemorrhage undergoing cesarean delivery is not well studied. OBJECTIVE: This study aimed to assess the role of tranexamic acid in reducing blood loss during elective and unscheduled cesarean deliveries in women at high risk of postpartum hemorrhage. STUDY DESIGN: This was a prospective, placebo-controlled, randomized controlled trial from March 2021 to February 2022 at the Karnatak Lingayat Education Society Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi, India. Women at a high risk of postpartum hemorrhage undergoing cesarean delivery were recruited and randomized to receive either tranexamic acid or placebo (1:1) at least 10 minutes before skin incision. High-risk factors for postpartum hemorrhage included obesity, hypertension, multiparity, previous cesarean delivery, multiple pregnancy, abnormally implanted placenta, placenta previa, abruption, uterine leiomyomas, polyhydramnios, and fetal macrosomia. The primary outcome was blood loss, calculated by a formula using pre- and postoperative hematocrit levels. In addition, gravimetrically measured blood loss was measured and compared between the 2 groups. RESULTS: A total of 212 women met the inclusion criteria and were randomized (tranexamic acid [n=106] and placebo [n=106]). The mean blood loss estimates were 400.9 mL in the tranexamic acid group and 597.9 mL in the placebo group (P<.001). The mean gravimetrically measured blood loss estimates were 379.2 mL in the tranexamic acid group and 431.1 mL in the placebo group (P<.001). In addition, there was a significant difference in the fall in hemoglobin levels (1.04 vs 1.61 g/dL) and change in hematocrit levels (3.20% vs 4.95%) from the pre- to postoperative period between the 2 groups (P<.001). No difference in the need for additional uterotonics (P=.26) or the need for postoperative parental iron (P=.18) was noted. No woman was transfused in either group. CONCLUSION: High-risk women receiving tranexamic acid had significantly less blood loss than women receiving placebo during cesarean delivery.

Docosahexaenoic Acid Supplementation in Lactating Women Increases Breast Milk and Erythrocyte Membrane Docosahexaenoic Acid Concentrations and Alters Infant n-6:n-3 Fatty Acid Ratio.

Background: Low concentrations of docosahexaenoic acid (DHA) or high n-6 (ω-6):n-3 ratio in pregnant women is associated with poor fetal growth velocity and suboptimal neurodevelopment. However, there is a lack of data on levels of important n-6 and n-3 fatty acids (FAs) at different time points during pregnancy and lactation from India. Data on how much DHA is transferred during actual supplementation are also scarce. Objectives: We report the concentrations of n-6 and n-3 FAs in maternal and infant blood and in breast milk following maternal supplementation with DHA or placebo. Methods: A total of 957 pregnant women (≤20 wk) from Belagavi, Karnataka, were randomly assigned to receive either 400 mg/d of algal DHA or placebo through 6 mo postpartum. Blood samples were collected from the mother at recruitment/baseline, delivery, and 6 mo postpartum and from the infant at birth (cord) and 12 mo (venous). Breast milk samples were collected from a subsample at delivery, 1 mo and 6 mo postpartum. The FA profile was analyzed using gas chromatography. Results: The concentration of DHA appeared to be higher in erythrocyte and breast milk samples of the DHA-supplemented group at all subsequent time points. The n-6:n-3 ratio was lower among women in the DHA group at delivery [DHA: 4.08 (1.79); placebo: 5.84 (3.57); P < 0.001] and at 6 mo postpartum [DHA: 5.34 (2.64); placebo: 7.69 (2.9); P < 0.001]. Infants of DHA-supplemented mothers also had a lower n-6:n-3 ratio at delivery and 12 mo. The n-6:n-3 ratio of breast milk increased from delivery through 1 to 6 mo but remained lower in the DHA-supplemented group than in the placebo. Conclusions: Maternal DHA supplementation with 400 mg/d from early pregnancy through 6 mo postpartum significantly increased circulating DHA in breast milk and infant erythrocyte, whereas decreased erythrocyte and breast milk n-6:n-3 ratio. However, maternal supplementation did not get the ratio to the recommended levels.

Infant Young Child Feeding Practices in an Indian Maternal-Child Birth Cohort in Belagavi, Karnataka.

Poor infant young child feeding (IYCF) practices result in malnutrition, poor psychosocial development, poor school performance and less productivity in later life, thereby perpetuating a vicious cycle. The current study aims to characterize the IYCF practices during the first year of life in a maternal-child birth cohort (DHANI) in Belagavi, Karnataka, India. We collected data from the dyad at birth, 6 and 12 months postpartum. We examined dietary diversity among these infants at 12 months using WHO criteria. A total of 902 live births were recorded, and 878 mother-child pairs completed the 12-month follow up. The overall prevalence of early (within 1 h of delivery) initiation of breastfeeding (EIBF) was 77.9%, and that of exclusive breastfeeding (EBF) at 6 months was 52.4%. At 12 months, most (90%) infants were breastfed, while 39% also received formula. The large majority (94.4%) of infants met minimum meal frequency (MMF), but only 55% of infants were receiving a minimum acceptable diet (MAD). The mean dietary diversity (DD) score was 4.7 ± 1.1. Only 21.9% of infants consumed egg and/or flesh food. A large proportion (33.8%) of infants received no vegetables and/or fruits till 12 months of age. Consumption of sweet beverage was 4.8%, but consumption of ultra-processed foods high in trans-fats, sugars and salt was high (85.8%). High-quality, sustainable and scalable interventions to enhance knowledge and support positive behaviour change for adopting and implementing better IYCF practices may be urgently needed in low- and middle-income group settings to improve diet diversity and overall nutritional intake amongst young children.

Prenatal Maternal Docosahexaenoic Acid (DHA) Supplementation and Newborn Anthropometry in India: Findings from DHANI.

Long-chain omega-3 fatty acid status during pregnancy may influence newborn anthropometry and duration of gestation. Evidence from high-quality trials from low- and middle-income countries (LMICs) is limited. We conducted a double-blind, randomized, placebo-controlled trial among 957 pregnant women (singleton gestation, 14-20 weeks' gestation at enrollment) in India to test the effectiveness of 400 mg/day algal docosahexaenoic acid (DHA) compared to placebo provided from enrollment through delivery. Among 3379 women who were screened, 1171 were found eligible; 957 were enrolled and were randomized. The intervention was two microencapsulated algal DHA (200 × 2 = 400 mg/day) or two microencapsulated soy and corn oil placebo tablets to be consumed daily from enrollment (≤20 weeks) through delivery. The primary outcome was newborn anthropometry (birth weight, length, head circumference). Secondary outcomes were gestational age and 1 and 5 min Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score. The groups (DHA; n = 478 and placebo; n = 479) were well balanced at baseline. There were 902 live births. Compliance with the intervention was similar across groups (DHA: 88.5%; placebo: 87.1%). There were no significant differences between DHA and placebo groups for birth weight (2750.6 ± 421.5 vs. 2768.2 ± 436.6 g, p = 0.54), length (47.3 ± 2.0 vs. 47.5 ± 2.0 cm, p = 0.13), or head circumference (33.7 ± 1.4 vs. 33.8 ± 1.4 cm, p = 0.15). The mean gestational age at delivery was similar between groups (DHA: 38.8 ± 1.7 placebo: 38.8 ± 1.7 wk, p = 0.54) as were APGAR scores at 1 and 5 min. Supplementing mothers through pregnancy with 400 mg/day DHA did not impact the offspring's birthweight, length, or head circumference.

Effect of Maternal Docosahexaenoic Acid (DHA) Supplementation on Offspring Neurodevelopment at 12 Months in India: A Randomized Controlled Trial.

Intake of dietary docosahexaenoic acid (DHA 22:6n-3) is very low among Indian pregnant women. Maternal supplementation during pregnancy and lactation may benefit offspring neurodevelopment. We conducted a double-blind, randomized, placebo-controlled trial to test the effectiveness of supplementing pregnant Indian women (singleton gestation) from ≤20 weeks through 6 months postpartum with 400 mg/d algal DHA compared to placebo on neurodevelopment of their offspring at 12 months. Of 3379 women screened, 1131 were found eligible; 957 were randomized. The primary outcome was infant neurodevelopment at 12 months, assessed using the Development Assessment Scale for Indian Infants (DASII). Both groups were well balanced on sociodemographic variables at baseline. More than 72% of women took >90% of their assigned treatment. Twenty-five serious adverse events (SAEs), none related to the intervention, (DHA group = 16; placebo = 9) were noted. Of 902 live births, 878 were followed up to 12 months; the DASII was administered to 863 infants. At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0, p = 0.60). Supplementing mothers through pregnancy and lactation with 400 mg/d DHA did not impact offspring neurodevelopment at 12 months of age in this setting.

Antepartum Risk Assessment for Pregnant Women Visiting a Tertiary Care University Teaching Hospital in Southern India.

AIM: The study was conducted to assess the prevalence of high-risk pregnancy (HRP) cases among pregnant women visiting the Prabhakar Kore Hospital (PKH) at Belagavi, Karnataka for antenatal care (ANC) and determination of the level of risk in the identified cases. MATERIALS & METHODS: Data were collected as a part of a screening procedure of a nutrition supplement clinical trial on pregnant women [Study title: Maternal DHA Supplementation and offspring Neurodevelopment in India (DHANI)]. ANC case records including detailed notes on medical and obstetric history, physical examination, laboratory investigations of pregnant women with ≤ 20 weeks of gestational age were screened for known risk factors. RESULTS: A total of 11,686 new cases were registered for ANC between June 2016 through August 2017. Of these, 3379 (<20 weeks gestation) were screened out of 428 pregnant women, 12.6% pregnant women were found to be at risk, 40.2% (n=172) fell in the high-risk category. Most commonly reported risk factors were thyroid disorders (27.3%, hypothyroidism 17.3%; hyperthyroidism 10%), gestational diabetes (16.1%), bad obstetric history (12.6%) and anaemia (10.7%). CONCLUSION: Early identification of these at-risk mothers through a simple, practical, reliable and customized risk scoring schedule can ensure interventions either to control the risk causing factor or delivery of timely and appropriate care as and when needed. CLINICAL SIGNIFICANCE: Considering the disproportionate burden that high risk pregnancies pose on higher mortality rates and compromised quality of life for the cases which survive, early identification of these high risk cases (12.6% identified in this study) can have a significant impact on maternal and child health. The population negatively affected by at-risk pregnancies is only expected to increase in the near future in light of the rising trend of its known risk factors such as high blood pressure, diabetes, or being HIV-positive.

The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol.

BACKGROUND: Evidence suggests a strong association between nutrition during the first 1000 days (conception to 2 years of life) and cognitive development. Maternal docosahexaenoic acid (DHA) supplementation has been suggested to be linked with cognitive development of their offspring. DHA is a structural component of human brain and retina, and can be derived from marine algae, fatty fish and marine oils. Since Indian diets are largely devoid of such products, plasma DHA levels are low. We are testing the effect of pre- and post-natal DHA maternal supplementation in India on infant motor and mental development, anthropometry and morbidity patterns. METHODS: DHANI is a double-blinded, parallel group, randomized, placebo controlled trial supplementing 957 pregnant women aged 18-35 years from ≤20 weeks gestation through 6 months postpartum with 400 mg/d algal-derived DHA or placebo. Data on the participant's socio-demographic profile, anthropometric measurements and dietary intake are being recorded at baseline. The mother-infant dyads are followed through age 12 months. The primary outcome variable is infant motor and mental development quotient at 12 months of age evaluated by Development Assessment Scale in Indian Infants (DASII). Secondary outcomes are gestational age, APGAR scores, and infant anthropometry. Biochemical indices (blood and breast-milk) from mother-child dyads are being collected to estimate changes in DHA levels in response to supplementation. All analyses will follow the intent-to-treat principle. Two-sample t test will be used to test unadjusted difference in mean DASII score between placebo and DHA group. Adjusted analyses will be performed using multiple linear regression. DISCUSSION: Implications for maternal and child health and nutrition in India: DHANI is the first large pre- and post-natal maternal dietary supplementation trial in India. If the trial finds substantial benefit, it can serve as a learning to scale up the DHA intervention in the country. TRIAL REGISTRATION: The trial is retrospectively registered at clinicaltrials.gov ( NCT01580345 , NCT03072277 ) and ctri.nic.in ( CTRI/2013/04/003540 , CTRI/2017/08/009296 ).

Neu-Laxova Syndrome: An Unusual Association with Kyphosis.

The Neu-Laxova syndrome is a rare autosomal recessive condition associated with neuro-ectodermal abnormalities and other patterns of severe malformations leading to prenatal or early postnatal lethality. Association with kyphosis is an extremely rare finding. A fetus born from a 25-year-old gravida at 30 weeks gestation was diagnosed with Dandy Walker syndrome with severe intrauterine growth restriction on ultrasonography. On post-mortem examination after termination of pregnancy, the fetus showed facial dysmorphology with microcephaly, smooth shiny skin and kyphosis. Skin histology showed hyperkeratosis, edema and increased subcutaneous fat suggestive of ichthyosis. On the basis of gross and microscopic features seen, a diagnosis of Neu-Laxova syndrome was made.

An Intervention to Enhance Obstetric and Newborn Care in India: A Cluster Randomized-Trial.

OBJECTIVES: This study assessed whether community mobilization and interventions to improve emergency obstetric and newborn care reduced perinatal mortality (PMR) and neonatal mortality rates (NMR) in Belgaum, India. METHODS: The cluster-randomised controlled trial was conducted in Belgaum District, Karnataka State, India. Twenty geographic clusters were randomized to control or the intervention. The intervention engaged and mobilized community and health authorities to leverage support; strengthened community-based stabilization, referral, and transportation; and aimed to improve quality of care at facilities. RESULTS: 17,754 Intervention births and 15,954 control births weighing ≥1000 g, respectively, were enrolled and analysed. Comparing the baseline period to the last 6 months period, the NMR was lower in the intervention versus control clusters (OR 0.60, 95% CI 0.34-1.06, p = 0.076) as was the PMR (OR 0.74, 95% CI 0.46-1.19, p = 0.20) although neither reached statistical significance. Rates of facility birth and caesarean section increased among both groups. There was limited influence on quality of care measures. CONCLUSIONS FOR PRACTICE: The intervention had large but not statistically significant effects on neonatal and perinatal mortality. Community mobilization and increased facility care may ultimately improve neonatal and perinatal survival, and are important in the context of the global transition towards institutional delivery.

Thanatophoric dysplasia type I: a rare case report at fetal autopsy.

Thanatophoric dysplasia type 1 is a lethal congenital anomaly with skeletal dysplasia. It is characterized by short limb dwarfism, enlarged head with frontal bossing, short neck, protuberant abdomen. It is detected in early gestational period by ultrasonography. The other associated anatomical abnormalities and characteristic laboratory findings aid in the early diagnosis and further work-up.

Provider insights on barriers and opportunities for birth spacing utilization in Karnataka, India.

India is the second most populous country in the world, with half of its citizens being of reproductive age. Despite the availability of a long-standing national family planning program, India maintains an unmet contraceptive need and high rate of maternal morbidity and mortality. In order to develop strategies to improve the utilization of birth-spacing contraceptive methods, we conducted a qualitative study with providers of family planning services in Karnataka, India. We elicited facilitators and barriers associated with peripartum contraceptive counseling and provision and identified an important opportunity to increase the use of postpartum contraception and improve birth spacing.

Maternal and perinatal outcome during expectant management of severe pre-eclampsia between 24 and 34 weeks of gestation.

OBJECTIVE: To determine the maternal and perinatal outcome after expectant management of severe pre-eclampsia between 24 and 34 weeks of gestation. METHOD: The maternal and fetal status was monitored by an intensive, non-invasive method among 94 women with severe pre-eclampsia between 24 and 34 weeks of gestation who were scheduled for expectant management in the OICU at a tertiary care center. Pregnancy prolongation and maternal and perinatal morbidity and mortality were analyzed by the Student 't' test and the Mann-Whitney U test. RESULTS: The days of pregnancy prolongation and perinatal mortality were significantly higher among those managed at <30 weeks. Increasing gestational age correlated with a reduction of RDS. Maternal morbidities were significantly higher among those managed at <28 weeks. But, there was no maternal mortality. CONCLUSION: Expectant management of severe pre-eclampsia at 30-34 weeks in a tertiary care center of a developing country is associated with good perinatal outcome and risk reduction for the mother.

Comparison of two WHO partographs: a one year randomized controlled trial.

OBJECTIVE: To compare two World Health Organization (WHO) partographs - a composite partograph including the latent phase with a simplified one without the latent phase in women with uncomplicated pregnancy. MATERIAL AND METHODS: This was a randomized controlled trial conducted at a tertiary hospital at Belgaum, India. 743 women with term, singleton, vertex gestation, in spontaneous labor were included in the study over a period of one year. Either of the partographs was used on laboring women. The following outcomes were compared: labor crossing the alert and action line, augmentation of labor, rate of cesarean section, perinatal outcome, user friendliness and maternal complications. Statistical analysis was done using Chi-square test. RESULTS: Labor values crossed the alert and action lines significantly more often when composite partograph was used (p<0.001) in each, with increased number of augmentations (p<0.001). The number of vaginal deliveries were high (p<0.005) in the simplified group. There was no significant difference in the rate of cesarean deliveries due to non progress of labor in both groups (p=0.68). NICU admissions were higher in the composite group (p=0.035). Most resident doctors (93%) experienced difficulty with the composite partograph, but no resident doctor reported difficulty with the simplified partograph. The mean SD user friendliness score was lower for the composite partograph (2.87±1.86 vs 10.67±1.61; p<0.005). CONCLUSION: The WHO simplified partograph is easier to use and is a better option for both the laboring women and the user, when compared to composite partograph.