Risk of Adverse Birth Outcomes in Two Cohorts of Pregnant Women With HIV in Zambia.


Journal

Epidemiology (Cambridge, Mass.)
ISSN: 1531-5487
Titre abrégé: Epidemiology
Pays: United States
ID NLM: 9009644

Informations de publication

Date de publication:
01 05 2022
Historique:
pubmed: 25 1 2022
medline: 8 4 2022
entrez: 24 1 2022
Statut: ppublish

Résumé

A trial of progesterone to prevent preterm birth among HIV-infected Zambian women [Improving Pregnancy Outcomes with Progesterone (IPOP)] found no treatment effect, but the risk of the primary outcome was among the lowest ever documented in women with HIV. In this secondary analysis, we compare the risks of preterm birth (<37 weeks), stillbirth, and a composite primary outcome comprising the two in IPOP versus an observational pregnancy cohort [Zambian Preterm Birth Prevention Study (ZAPPS)] in Zambia, to evaluate reasons for the low risk in IPOP. Both studies enrolled women before 24 gestational weeks, during August 2015-September 2017 (ZAPPS) and February 2018-January 2020 (IPOP). We used linear probability and log-binomial regression to estimate risk differences and risk ratios (RR), before and after restriction and standardization with inverse probability weights. The unadjusted risk of composite outcome was 18% in ZAPPS (N = 1450) and 9% in IPOP (N = 791) (RR = 2.0; 95% CI = 1.6, 2.6). After restricting and standardizing the ZAPPS cohort to the distribution of IPOP baseline characteristics, the risk remained higher in ZAPPS (RR = 1.6; 95% CI = 1.0, 2.4). The lower risk of preterm/stillbirth in IPOP was only partially explained by measured risk factors. Possible benefits in IPOP of additional monetary reimbursement, more frequent visits, and group-based care warrant further investigation.

Sections du résumé

BACKGROUND
A trial of progesterone to prevent preterm birth among HIV-infected Zambian women [Improving Pregnancy Outcomes with Progesterone (IPOP)] found no treatment effect, but the risk of the primary outcome was among the lowest ever documented in women with HIV. In this secondary analysis, we compare the risks of preterm birth (<37 weeks), stillbirth, and a composite primary outcome comprising the two in IPOP versus an observational pregnancy cohort [Zambian Preterm Birth Prevention Study (ZAPPS)] in Zambia, to evaluate reasons for the low risk in IPOP.
METHODS
Both studies enrolled women before 24 gestational weeks, during August 2015-September 2017 (ZAPPS) and February 2018-January 2020 (IPOP). We used linear probability and log-binomial regression to estimate risk differences and risk ratios (RR), before and after restriction and standardization with inverse probability weights.
RESULTS
The unadjusted risk of composite outcome was 18% in ZAPPS (N = 1450) and 9% in IPOP (N = 791) (RR = 2.0; 95% CI = 1.6, 2.6). After restricting and standardizing the ZAPPS cohort to the distribution of IPOP baseline characteristics, the risk remained higher in ZAPPS (RR = 1.6; 95% CI = 1.0, 2.4). The lower risk of preterm/stillbirth in IPOP was only partially explained by measured risk factors.
CONCLUSIONS
Possible benefits in IPOP of additional monetary reimbursement, more frequent visits, and group-based care warrant further investigation.

Identifiants

pubmed: 35067569
doi: 10.1097/EDE.0000000000001465
pii: 00001648-202205000-00016
pmc: PMC9516482
mid: NIHMS1834875
doi:

Types de publication

Journal Article Observational Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

422-430

Subventions

Organisme : FIC NIH HHS
ID : K01 TW010857
Pays : United States
Organisme : NIAID NIH HHS
ID : P30 AI050410
Pays : United States
Organisme : NICHD NIH HHS
ID : R01 HD087119
Pays : United States
Organisme : NICHD NIH HHS
ID : T32 HD075731
Pays : United States

Informations de copyright

Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.

Déclaration de conflit d'intérêts

The authors report no conflicts of interest.

Références

Chawanpaiboon S, Vogel JP, Moller AB, et al. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Glob Health. 2019;7:e37–e46.
Lawn JE, Blencowe H, Waiswa P, et al.; Lancet Ending Preventable Stillbirths Series study group; Lancet Stillbirth Epidemiology investigator group. Stillbirths: rates, risk factors, and acceleration towards 2030. Lancet. 2016;387:587–603.
Wedi CO, Kirtley S, Hopewell S, Corrigan R, Kennedy SH, Hemelaar J. Perinatal outcomes associated with maternal HIV infection: a systematic review and meta-analysis. Lancet HIV. 2016;3:e33–e48.
Price JT, Vwalika B, Edwards JK, et al. Maternal HIV infection and spontaneous versus provider-initiated preterm birth in an urban Zambian cohort. J Acquir Immune Defic Syndr. 2021;87:860–868.
Uthman OA, Nachega JB, Anderson J, et al. Timing of initiation of antiretroviral therapy and adverse pregnancy outcomes: a systematic review and meta-analysis. Lancet HIV. 2017;4:e21–e30.
Chen JY, Ribaudo HJ, Souda S, et al. Highly active antiretroviral therapy and adverse birth outcomes among HIV-infected women in Botswana. J Infect Dis. 2012;206:1695–1705.
Zash R, Jacobson DL, Diseko M, et al. Comparative safety of dolutegravir-based or efavirenz-based antiretroviral treatment started during pregnancy in Botswana: an observational study. Lancet Glob Health. 2018;6:e804–e810.
Malaba TR, Newell ML, Madlala H, Perez A, Gray C, Myer L. Methods of gestational age assessment influence the observed association between antiretroviral therapy exposure, preterm delivery, and small-for-gestational age infants: a prospective study in Cape Town, South Africa. Ann Epidemiol. 2018;28:893–900.
van der Merwe K, Hoffman R, Black V, Chersich M, Coovadia A, Rees H. Birth outcomes in South African women receiving highly active antiretroviral therapy: a retrospective observational study. J Int AIDS Soc. 2011;14:42.
Li N, Sando MM, Spiegelman D, et al. Antiretroviral therapy in relation to birth outcomes among HIV-infected Women: A Cohort Study. J Infect Dis. 2016;213:1057–1064.
Zash R, Souda S, Chen JY, et al. Reassuring birth outcomes with tenofovir/emtricitabine/efavirenz used for prevention of mother-to-child transmission of HIV in Botswana. J Acquir Immune Defic Syndr. 2016;71:428–436.
Price JT, Vwalika B, Rittenhouse KJ, et al. Adverse birth outcomes and their clinical phenotypes in an urban Zambian cohort. Gates Open Res. 2019;3:1533.
Malaba TR, Phillips T, Le Roux S, et al. Antiretroviral therapy use during pregnancy and adverse birth outcomes in South African women. Int J Epidemiol. 2017;46:1678–1689.
Stringer EM, Vwalika B, Killam WP, et al. Determinants of stillbirth in Zambia. Obstet Gynecol. 2011;117:1151–1159.
Kupka R, Kassaye T, Saathoff E, Hertzmark E, Msamanga GI, Fawzi WW. Predictors of stillbirth among HIV-infected Tanzanian women. Acta Obstet Gynecol Scand. 2009;88:584–592.
Medley N, Vogel JP, Care A, Alfirevic Z. Interventions during pregnancy to prevent preterm birth: an overview of Cochrane systematic reviews. Cochrane Database Syst Rev. 2018;11:CD012505.
Dodd J, Jones L, Flenady V, Cincotta R, Crowther C. Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth. Cochrane Database Syst Rev. 2013;31:CD004947.
Romero R, Conde-Agudelo A, Da Fonseca E, et al. Vaginal progesterone for preventing preterm birth and adverse perinatal outcomes in singleton gestations with a short cervix: a meta-analysis of individual patient data. Am J Obstet Gynecol. 2018;218:161–180.
Norman JE, Marlow N, Messow CM, et al. Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial. Lancet. 2016;387:21062116.
Blackwell SC, Gyamfi-Bannerman C, Biggio JR Jr, et al. 17-OHPC to prevent recurrent preterm birth in singleton gestations (PROLONG study): a multicenter, international, randomized double-blind trial. Am J Perinatol. 2020;37:127–136.
Meis PJ, Klebanoff M, Thom E, et al.; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003;348:2379–2385.
Hileman CO, Funderburg NT. Inflammation, immune activation, and antiretroviral therapy in HIV. Curr HIV/AIDS Rep. 2017;14:93–100.
Bélec L, Gherardi R, Payan C, et al. Proinflammatory cytokine expression in cervicovaginal secretions of normal and HIV-infected women. Cytokine. 1995;7:568–574.
Rinaldi SF, Hutchinson JL, Rossi AG, Norman JE. Anti-inflammatory mediators as physiological and pharmacological regulators of parturition. Expert Rev Clin Immunol. 2011;7:675–696.
Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008;371:75–84.
Price JT, Vwalika B, Freeman BL, et al. Intramuscular 17-hydroxyprogesterone caproate to prevent preterm birth among HIV-infected women in Zambia: study protocol of the IPOP randomized trial. BMC Pregnancy Childbirth. 2019;19:81.
Price JT, Vwalika B, Freeman BL, et al. Weekly 17 alpha-hydroxyprogesterone caproate to prevent preterm birth among women living with HIV: a randomised, double-blind, placebo-controlled trial. Lancet HIV. 2021;8:e605–e613.
Castillo MC, Fuseini NM, Rittenhouse K, et al. The Zambian Preterm Birth Prevention Study (ZAPPS): Cohort characteristics at enrollment. Gates Open Res. 2018;2:25.
Papageorghiou AT, Kemp B, Stones W, et al.; International Fetal and Newborn Growth Consortium for the 21 st Century (INTERGROWTH-21 st ). Ultrasound-based gestational-age estimation in late pregnancy. Ultrasound Obstet Gynecol. 2016;48:719–726.
Papageorghiou AT, Kennedy SH, Salomon LJ, et al.; International Fetal and Newborn Growth Consortium for the 21 st Century (INTERGROWTH-21 st ). International standards for early fetal size and pregnancy dating based on ultrasound measurement of crown-rump length in the first trimester of pregnancy. Ultrasound Obstet Gynecol. 2014;44:641–648.
Perkins NJ, Cole SR, Harel O, et al. Principled approaches to missing data in epidemiologic studies. Am J Epidemiol. 2018;187:568–575.
Harel O, Mitchell EM, Perkins NJ, et al. Multiple imputation for incomplete data in epidemiologic studies. Am J Epidemiol. 2018;187:576–584.
Sato T, Matsuyama Y. Marginal structural models as a tool for standardization. Epidemiology. 2003;14:680–686.
Howe CJ, Cole SR, Westreich DJ, Greenland S, Napravnik S, Eron JJ Jr. Splines for trend analysis and continuous confounder control. Epidemiology. 2011;22:874–875.
Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res. 2011;46:399–424.
Morgan SL, Todd JJ. VI. A diagnostic routine for the detection of consequential heterogeneity of causal effects. Sociol Methodol. 2008;38:231282.
Cole SR, Hernán MA. Constructing inverse probability weights for marginal structural models. Am J Epidemiol. 2008;168:656–664.
Efron B, Gong G. A leisurely look at the bootstrap, the jackknife, and cross-validation. Am Stat. 1983;37:3648.
Weber KA, Carmichael SL, Yang W, Tinker SC, Shaw GM; National Birth Defects Prevention Study. Periconceptional stressors and social support and risk for adverse birth outcomes. BMC Pregnancy Childbirth. 2020;20:487.
Staneva A, Bogossian F, Pritchard M, Wittkowski A. The effects of maternal depression, anxiety, and perceived stress during pregnancy on preterm birth: a systematic review. Women Birth. 2015;28:179–193.
Dadi AF, Miller ER, Bisetegn TA, Mwanri L. Global burden of antenatal depression and its association with adverse birth outcomes: an umbrella review. BMC Public Health. 2020;20:173.
Fekadu Dadi A, Miller ER, Mwanri L. Antenatal depression and its association with adverse birth outcomes in low and middle-income countries: a systematic review and meta-analysis. PLoS One. 2020;15:e0227323.
Lima SAM, El Dib RP, Rodrigues MRK, et al. Is the risk of low birth weight or preterm labor greater when maternal stress is experienced during pregnancy? A systematic review and meta-analysis of cohort studies. PLoS One. 2018;13:e0200594.
Hobel C, Culhane J. Role of psychosocial and nutritional stress on poor pregnancy outcome. J Nutr. 2003;133(5 Suppl 2):1709S–1717S.
Lagarde M, Haines A, Palmer N. The impact of conditional cash transfers on health outcomes and use of health services in low and middle income countries. Cochrane Database Syst Rev. 2009;2009:CD008137.
Pega F, Liu SY, Walter S, Pabayo R, Saith R, Lhachimi SK. Unconditional cash transfers for reducing poverty and vulnerabilities: effect on use of health services and health outcomes in low- and middle-income countries. Cochrane Database Syst Rev. 2017;11:CD011135.
Brownell M, Nickel NC, Chartier M, et al. An unconditional prenatal income supplement reduces population inequities in birth outcomes. Health Aff (Millwood). 2018;37:447–455.
Brownell MD, Chartier MJ, Nickel NC, et al.; PATHS Equity for Children Team. Unconditional prenatal income supplement and birth outcomes. Pediatrics. 2016;137:e20152992.
World Bank, Development Research Group. PovcalNet: an online analysis tool for global poverty monitoring. Available at: http://iresearch.worldbank.org/PovcalNet/home.aspx . Accessed 28 September 2021.
Rising SS. Centering pregnancy. An interdisciplinary model of empowerment. J Nurse Midwifery. 1998;43:46–54.
Rising SS, Kennedy HP, Klima CS. Redesigning prenatal care through Centering Pregnancy. J Midwifery Womens Health. 2004;49:398–404.
Ruiz-Mirazo E, Lopez-Yarto M, McDonald SD. Group prenatal care versus individual prenatal care: a systematic review and meta-analyses. J Obstet Gynaecol Can. 2012;34:223–229.
Carter EB, Temming LA, Akin J, et al. Group prenatal care compared with traditional prenatal care: a systematic review and meta-analysis. Obstet Gynecol. 2016;128:551–561.
Catling CJ, Medley N, Foureur M, et al. Group versus conventional antenatal care for women. Cochrane Database Syst Rev. 2015;2105:CD007622.
Cunningham SD, Lewis JB, Shebl FM, et al. Group prenatal care reduces risk of preterm birth and low birth weight: A Matched Cohort Study. J Womens Health (Larchmt). 2019;28:17–22.
Grenier L, Suhowatsky S, Kabue MM, et al. Impact of group antenatal care (G-ANC) versus individual antenatal care (ANC) on quality of care, ANC attendance and facility-based delivery: a pragmatic cluster-randomized controlled trial in Kenya and Nigeria. PLoS One. 2019;14:e0222177.
Eluwa GI, Adebajo SB, Torpey K, et al. The effects of centering pregnancy on maternal and fetal outcomes in northern Nigeria; a prospective cohort analysis. BMC Pregnancy Childbirth. 2018;18:158.
Lori JR, Chuey M, Munro-Kramer ML, Ofosu-Darkwah H, Adanu RMK. Increasing postpartum family planning uptake through group antenatal care: a longitudinal prospective cohort design. Reprod Health. 2018;15:208.
Musange SF, Butrick E, Lundeen T, et al. Group antenatal care versus standard antenatal care and effect on mean gestational age at birth in Rwanda: protocol for a cluster randomized controlled trial. Gates Open Res. 2019;3:1548.
Kabue MM, Grenier L, Suhowatsky S, et al. Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria. Gates Open Res. 2018;2:56.
Caniglia EC, Abrams J, Diseko M, et al. Seasonality of adverse birth outcomes in women with and without HIV in a representative birth outcomes surveillance study in Botswana. BMJ Open. 2021;11:e045882.

Auteurs

Joan T Price (JT)

From the Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia.
University of North Carolina Global Projects Zambia, Lusaka, Zambia.

Yuri V Sebastião (YV)

From the Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Bellington Vwalika (B)

From the Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia.

Stephen R Cole (SR)

Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Felistas M Mbewe (FM)

University of North Carolina Global Projects Zambia, Lusaka, Zambia.

Winifreda M Phiri (WM)

University of North Carolina Global Projects Zambia, Lusaka, Zambia.

Bethany L Freeman (BL)

From the Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Margaret P Kasaro (MP)

Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia.
University of North Carolina Global Projects Zambia, Lusaka, Zambia.

Marc Peterson (M)

From the Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Dwight J Rouse (DJ)

Department of Obstetrics and Gynecology, Brown University, Providence, RI, USA.

Elizabeth M Stringer (EM)

From the Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Jeffrey S A Stringer (JSA)

From the Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

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