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1. Antenatal Dexamethasone for Early Preterm Birth in Low-resource Countries

Author

Oladapo, O.T., Vogel, J.P., Piaggio, G., Nguyen, M.H., Althabe, F., Gülmezoglu, A.M., Bahl, R., Rao, S.P.N., De Costa, A., Gupta, S., Baqui, A.H., Khanam, R., Shahidullah, M., Chowdhury, S.B., Ahmed, S., Begum, N., D Roy, A., Shahed, M.A., Jaben, I.A., Yasmin, F., Rahman, M.M., Ara, A., Khatoon, S., Ara, G., Akter, S., Akhter, N., Dey, P.R., Sabur, M.A., Azad, M.T., Choudhury, S.F., Matin, M.A., Goudar, S.S., Dhaded, S.M., Metgud, M.C., Pujar, Y.V., Somannavar, M.S., Vernekar, S.S., Herekar, V.R., Bidri, S.R., Mathapati, S.S., Patil, P.G., Patil, M.M., Gudadinni, M.R., Bijapure, H.R., Mallapur, A.A., Katageri, G.M., Chikkamath, S.B., Yelamali, B.C., Pol, R.R., Misra, S.S., Das, L., Nanda, S., Nayak, R.B., Singh, B., Qureshi, Z., Were, F., Osoti, A., Gwako, G., Laving, A., Kinuthia, J., Mohamed, H., Aliyan, N., Barassa, A., Kibaru, E., Mbuga, M., Thuranira, L., Githua, N.J., Lusweti, B., Ayede, A.I., Falade, A.G., Adesina, O.A., Agunloye, A.M., Iyiola, O.O., Sanni, W., Ejinkeonye, I.K., Idris, H.A., Okoli, C.V., Irinyenikan, T.A., Olubosede, O.A., Bello, O., Omololu, O.M., Olutekunbi, O.A., Akintan, A.L., Owa, O.O., Oluwafemi, R.O., Eniowo, I.P., Fabamwo, A.O., Disu, E.A., Agbara, J.O., Adejuyigbe, E.A., Kuti, O., Anyabolu, H.C., Awowole, I.O., Fehintola, A.O., Kuti, B.P., Isah, A.D., Olateju, E.K., Abiodun, O., Dedeke, O.F., Akinkunmi, F.B., Oyeneyin, L., Adesiyun, O., Raji, H.O., Ande, A.B.A., Okonkwo, ., I, Ariff, S., Soofi, S.B., Sheikh, L., Zulfiqar, S., Omer, S., Sikandar, R., Sheikh, S., Giordano, D., Gamerro, H., Carroli, G., Carvalho, J., Neilson, J., Molyneux, E., Yunis, K., Mugerwa, K., and Chellani, H.K.

Published
2021
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2. DECISION TO DELIVERY INTERVAL OF EMERGENCY CAESAREAN SECTION AND ASSOCIATED MATERNAL AND NEONATAL OUTCOMES IN A COUNTY HOSPITAL IN KENYA.

Author

Kanario, P., Mburugu, P., Kabuga, S., Wangari, L., Wanjiku, L., Luchemo, P., Simba, J., Nyariki, C. M., Thuo, R., Makworo, D., and Lusweti, B.

Subjects
CESAREAN section, NEWBORN infants, LABOR complications (Obstetrics), RESPIRATORY distress syndrome, STILLBIRTH
Abstract

Objective: The objective of the study was to determine the decision to delivery interval and the associated maternal and neonatal outcomes at Thika level five hospital. Design: Ambidirectional study Setting: Secondary Level Hospital in Kenya Subjects: Four hundred and nineteen mothers who underwent emergency caesarean section and their newborns Main outcome measure: Decision to delivery interval, maternal and neonatal outcomes. Results: The median decision to delivery interval was 248 minutes. Only 1% attained the recommended decision to delivery interval of ≤30 minutes. Majority of the participants (40.1%) had a decision to delivery interval above 300 minutes. Six percent of the mothers developed complications among which postpartum haemorrhage accounted for 1.9% (n=8), wound sepsis 0.7% (n=3), ruptured uterus 0.5% (n=2) and maternal deaths recorded were 0.5% (n=2). There was no significant association between DDI and maternal complications. Of the newborn admissions, meconium aspiration syndrome accounted for 17.6%, respiratory distress syndrome 17.6% and birth asphyxia 12.0%. Perinatal deaths recorded were 1.4%, fresh and macerated still births were 2.6% and 1%, respectively. There was a significance association between prolonged DDI and neonatal outcome (p=0.024) Conclusions: Decision to delivery interval at Thika Level Five Hospital was longer than the recommended. There was no significant association between the decision to delivery interval and the maternal complications and prolonged duration of hospital stay. Prolonged decision to delivery interval significantly influenced the neonatal outcome. [ABSTRACT FROM AUTHOR]

Published
2021

3. The World Health Organization ACTION-I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) Trial: a multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries

Author

Bahl, R, Gulmezoglu, AM, My, HN, Oladapo, OT, Piaggio, G, Vogel, JP, Baqui, AH, Chowdhury, SB, Shahidullah, M, Goudar, S, Dhaded, SM, Mallapur, AA, Bidri, S, Misra, S, Kinuthia, J, Qureshi, Z, Were, F, Ayede, AI, Fawole, B, Adesina, OA, Adejuyigbe, EA, Kuti, O, Ariff, S, Sheikh, L, Soofi, S, Neilson, J, Althabe, F, Chellani, H, Molyneux, E, Mugerwa, K, Yunis, K, Campodonico, L, Carroli, G, Gamerro, H, Giordano, D, Patterson, J, Khanam, R, Harrison, M, Mannan, MA, Nasrin, B, Ahmed, S, Begum, N, Sultana, S, Khatoon, S, Ara, A, Chowdhury, MA, Dey, PR, Bhowmik, DK, Sabur, MA, Azad, MT, Ara, G, Akter, S, Bari, S, Rahman, MM, Yasmin, F, Matin, MA, Choudhury, SF, Goudar, SS, Metgud, MC, Pujar, YV, Somannavar, MS, Vernekar, SS, Herekar, V, Machakanur, VL, Andola, SS, Katageri, GM, Math, S, Yelamali, BC, Pol, R, Ramdurg, U, Bidri, SR, Mathpati, S, Patil, P, Lakhkar, BB, Patil, MM, Gudadinni, MR, Misra, SS, Padhi, M, Das, LB, Das, L, Nanda, SS, Pradhan, MJ, Mohanty, GSG, Nayak, RS, Singh, BS, Osoti, A, Gwako, G, Laving, A, Mohamed, H, Nassir, F, Mohamed, N, Barassa, A, Ogindo, J, Gwer, B, Salome, W, Ochieng, G, Githua, NJ, Lusweti, B, Okunlola, MA, Falade, AG, Ashubu, OF, Busari, O, Sanni, W, Ebedi, A, Kate, EI, Violet, O, Idris, HA, Sallau, FA, Viola, OC, Osaretin, EL, Irinyenikan, TA, Olubosede, OA, Omololu, OM, Runsewe, O, Imam, Z, Akintan, AL, Owa, OO, Oluwafemi, OR, Eniowo, IP, Fabamwo, A, Disu, E, Awowole, IO, Adeyemi, AB, Fehintola, AO, Anyabolu, HC, Kuti, BP, Famurewa, OC, Ande, ABA, Okonkwo, I, Peter, AA, Olugbenga, M, Adesiyun, O, Isah, AD, Kudirat, OE, Abiodun, O, Dedeke, OF, Oyeneyin, L, Akinkunmi, FB, Soofi, SB, Najimi, N, Ali, M, Anwar, J, Zulfiqar, S, Sikander, R, Rani, S, Sheikh, S, Memon, S, Bahl, R, Gulmezoglu, AM, My, HN, Oladapo, OT, Piaggio, G, Vogel, JP, Baqui, AH, Chowdhury, SB, Shahidullah, M, Goudar, S, Dhaded, SM, Mallapur, AA, Bidri, S, Misra, S, Kinuthia, J, Qureshi, Z, Were, F, Ayede, AI, Fawole, B, Adesina, OA, Adejuyigbe, EA, Kuti, O, Ariff, S, Sheikh, L, Soofi, S, Neilson, J, Althabe, F, Chellani, H, Molyneux, E, Mugerwa, K, Yunis, K, Campodonico, L, Carroli, G, Gamerro, H, Giordano, D, Patterson, J, Khanam, R, Harrison, M, Mannan, MA, Nasrin, B, Ahmed, S, Begum, N, Sultana, S, Khatoon, S, Ara, A, Chowdhury, MA, Dey, PR, Bhowmik, DK, Sabur, MA, Azad, MT, Ara, G, Akter, S, Bari, S, Rahman, MM, Yasmin, F, Matin, MA, Choudhury, SF, Goudar, SS, Metgud, MC, Pujar, YV, Somannavar, MS, Vernekar, SS, Herekar, V, Machakanur, VL, Andola, SS, Katageri, GM, Math, S, Yelamali, BC, Pol, R, Ramdurg, U, Bidri, SR, Mathpati, S, Patil, P, Lakhkar, BB, Patil, MM, Gudadinni, MR, Misra, SS, Padhi, M, Das, LB, Das, L, Nanda, SS, Pradhan, MJ, Mohanty, GSG, Nayak, RS, Singh, BS, Osoti, A, Gwako, G, Laving, A, Mohamed, H, Nassir, F, Mohamed, N, Barassa, A, Ogindo, J, Gwer, B, Salome, W, Ochieng, G, Githua, NJ, Lusweti, B, Okunlola, MA, Falade, AG, Ashubu, OF, Busari, O, Sanni, W, Ebedi, A, Kate, EI, Violet, O, Idris, HA, Sallau, FA, Viola, OC, Osaretin, EL, Irinyenikan, TA, Olubosede, OA, Omololu, OM, Runsewe, O, Imam, Z, Akintan, AL, Owa, OO, Oluwafemi, OR, Eniowo, IP, Fabamwo, A, Disu, E, Awowole, IO, Adeyemi, AB, Fehintola, AO, Anyabolu, HC, Kuti, BP, Famurewa, OC, Ande, ABA, Okonkwo, I, Peter, AA, Olugbenga, M, Adesiyun, O, Isah, AD, Kudirat, OE, Abiodun, O, Dedeke, OF, Oyeneyin, L, Akinkunmi, FB, Soofi, SB, Najimi, N, Ali, M, Anwar, J, Zulfiqar, S, Sikander, R, Rani, S, Sheikh, S, and Memon, S

Abstract

BACKGROUND: Antenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of a preterm birth. However, the safety and efficacy of ACS in hospitals in low-resource countries has not been established in an efficacy trial despite their widespread use. Findings of a large cluster-randomized trial in six low- and middle-income countries showed that efforts to scale up ACS use in low-resource settings can lead to harm. There is equipoise regarding the benefits and harms of ACS use in hospitals in low-resource countries. This randomized controlled trial aims to determine whether ACS are safe and efficacious when given to women at risk of imminent birth in the early preterm period, in hospitals in low-resource countries. METHODS/DESIGN: The trial design is a parallel, two-arm, double-blind, individually randomized, placebo-controlled trial of ACS (dexamethasone) for women at risk of imminent preterm birth. The trial will recruit 6018 women in participating hospitals across five low-resource countries (Bangladesh, India, Kenya, Nigeria and Pakistan). The primary objectives are to compare the efficacy of dexamethasone with placebo on survival of the baby and maternal infectious morbidity. The primary outcomes are: 1) neonatal death (to 28 completed days of life); 2) any baby death (any stillbirth postrandomization or neonatal death); and 3) a composite outcome to assess possible maternal bacterial infections. The trial will recruit eligible, consenting pregnant women from 26 weeks 0 days to 33 weeks 6 days gestation with confirmed live fetuses, in whom birth is planned or expected within 48 h. The intervention comprises a regimen of intramuscular dexamethasone sodium phosphate. The comparison is an identical placebo regimen (normal saline). A total of 6018 women will be recruited to detect a reduction of 15% or more in neonatal deaths in a two-sided 5% significance test with 90% power (including 10% loss to follow-up).

Published
2019

4. Prevalence of acute kidney injury and its characteristics among neonates with suspected sepsis in a tertiary hospital in Kenya.

Author

Munyendo C, Admani B, Mburugu P, Simba J, Lusweti B, Gachara N, and Laving A

Subjects
Infant, Newborn, Pregnancy, Female, Humans, Prevalence, Tertiary Care Centers, Kenya epidemiology, Cross-Sectional Studies, Risk Factors, Acute Kidney Injury epidemiology, Acute Kidney Injury etiology, Sepsis epidemiology, Pregnancy Complications
Abstract

Introduction: Unique aspects of neonatal renal physiology enhance the occurrence of Acute Kidney Injury (AKI) as a complication of neonatal sepsis. The study sought to determine prevalence of AKI and its characteristics in neonates with suspected sepsis., Methods: A cross-sectional study was conducted at Kenyatta National Hospital among neonates aged 0-28 days. AKI was defined as serum creatinine of more than 100µmmol/l., Results: Among 332 neonates included 120 had AKI giving a prevalence of 36.1% (95% CI 31 to 41.6). Based on RIFLE criteria the commonest AKI presentation was Failure 72 (62.6%, 95% CI 53.6 to 71.6), followed by Injury 26 (22.6%, 95% CI 14.8 to 30.4) and then Risk 17 (14.8%, 95% CI 8.2 to 21.3). AKI was more common in neonates with suspected late onset sepsis (p=0.004). Maternal fever in the preceding week to delivery and presence of either puerperal sepsis or post-partum hemorrhage were significantly associated with severe AKI (p=0.004 and p=0.038)., Conclusion: Prevalence of AKI was high; those with suspected late onset sepsis were more likely to develop AKI compared to early onset sepsis. Presence of maternal fever preceding delivery and presence of either puerperal sepsis or postpartum hemorrhage were associated with severe forms of AKI., Competing Interests: Authors of this article disclose no conflict of interest in this study and its publication., (© 2023 Munyendo C et al.)

Published
2023
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5. Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries.

Author

Oladapo OT, Vogel JP, Piaggio G, Nguyen MH, Althabe F, Gülmezoglu AM, Bahl R, Rao SPN, De Costa A, Gupta S, Baqui AH, Khanam R, Shahidullah M, Chowdhury SB, Ahmed S, Begum N, D Roy A, Shahed MA, Jaben IA, Yasmin F, Rahman MM, Ara A, Khatoon S, Ara G, Akter S, Akhter N, Dey PR, Sabur MA, Azad MT, Choudhury SF, Matin MA, Goudar SS, Dhaded SM, Metgud MC, Pujar YV, Somannavar MS, Vernekar SS, Herekar VR, Bidri SR, Mathapati SS, Patil PG, Patil MM, Gudadinni MR, Bijapure HR, Mallapur AA, Katageri GM, Chikkamath SB, Yelamali BC, Pol RR, Misra SS, Das L, Nanda S, Nayak RB, Singh B, Qureshi Z, Were F, Osoti A, Gwako G, Laving A, Kinuthia J, Mohamed H, Aliyan N, Barassa A, Kibaru E, Mbuga M, Thuranira L, Githua NJ, Lusweti B, Ayede AI, Falade AG, Adesina OA, Agunloye AM, Iyiola OO, Sanni W, Ejinkeonye IK, Idris HA, Okoli CV, Irinyenikan TA, Olubosede OA, Bello O, Omololu OM, Olutekunbi OA, Akintan AL, Owa OO, Oluwafemi RO, Eniowo IP, Fabamwo AO, Disu EA, Agbara JO, Adejuyigbe EA, Kuti O, Anyabolu HC, Awowole IO, Fehintola AO, Kuti BP, Isah AD, Olateju EK, Abiodun O, Dedeke OF, Akinkunmi FB, Oyeneyin L, Adesiyun O, Raji HO, Ande ABA, Okonkwo I, Ariff S, Soofi SB, Sheikh L, Zulfiqar S, Omer S, Sikandar R, Sheikh S, Giordano D, Gamerro H, Carroli G, Carvalho J, Neilson J, Molyneux E, Yunis K, Mugerwa K, and Chellani HK

Subjects
Adult, Developing Countries, Female, Humans, Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Infant, Premature, Diseases epidemiology, Injections, Intramuscular, Pregnancy, Premature Birth, Risk, Stillbirth epidemiology, Dexamethasone administration & dosage, Glucocorticoids administration & dosage, Infant, Premature, Diseases prevention & control, Perinatal Death prevention & control, Prenatal Care
Abstract

Background: The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain., Methods: We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale., Results: A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P = 0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events., Conclusions: Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection. (Funded by the Bill and Melinda Gates Foundation and the World Health Organization; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000476336; Clinical Trials Registry-India number, CTRI/2017/04/008326.)., (Copyright © 2020 Massachusetts Medical Society.)

Published
2020
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