| Study | Exclusion reasons | Rmk | Reference |
|---|---|---|---|
| Le Roux, 2017 | inadequate or absent control group | EXCLUDED: study performed according to duration of TDF exposure. All pregnant women exposed to TDF. No adequate control group. | |
| Brown, 2012 | inadequate or absent control group | EXCLUDED: no internal comparator (comparison with prevalence of MACDP, European collaborative study, UK an Ireland database). | |
| Santosa, 2019 | inadequate or absent control group | EXCLUDED: No adequate control group. Almost all women treated with TDF-based regimens and analysis according to the timing of initiation (before or during pregnancy). |
Santosa AIDS 2019; 33:1623-1633 10.1097/QAD.0000000000002222 |
| le Roux, 2019 | inadequate or absent control group | EXCLUDED: all pregnant women exposed to tenofovir/emtricitabine/efavirenz. No control group. |
le Roux Pediatr. Infect. Dis. J. 2019; 38:70-75 10.1097/INF.0000000000002193 |
| Hitti, 2007 | inadequate or absent control group | EXCLUDED: Analysis of protease inhibitor versus no protease inhibitor, with tenofovir in both groups. No adequate control group. |
Hitti Am. J. Obstet. Gynecol. 2007; 196:331.e1-7 10.1016/j.ajog.2006.11.037 |
| Jao, 2016 | inadequate or absent control group | EXCLUDED: all pregnant women exposed to tenofovir. No adequate control group. |
Jao Clin. Infect. Dis. 2016; 62:1604-1609 10.1093/cid/ciw159 |
| Hu, 2015 | inadequate or absent control group | EXCLUDED: all pregnancies exposed to tenofovir. No adequate control group. |
Hu World J. Gastroenterol. 2015; 21:2504-9 10.3748/wjg.v21.i8.2504 |
| Denneman, 2016 | inadequate or absent control group | EXCLUDED: all pregnant women exposed to tenofovir. No adequate control group. | |
| Gao, 2020 | inadequate or absent control group | EXCLUDED: In the control group, women discontinued antiviral therapy (unspecified) before (37/43; 86%) or during first trimester (6/43; 14%) at the median gestational age of 5 weeks. No adequate control group. | |
| Wang, 2015 | inadequate or absent control group | EXCLUDED: All pregnancies exposed to tenofovir (at different stages of pregnancy). No adequate control group. | |
| Himes, 2015 | inadequate or absent control group | EXCLUDED: all pregnancies exposed to tenofovir. NO adequate control group. |
Himes Pediatr. Infect. Dis. J. 2015; 34:851-7 10.1097/INF.0000000000000747 |
| Onyango-Makumbi, 2014 | not about fetal exposure | EXCLUDED: not related to exposure during pregnancy (analysis of HIV infected lactating women enrolled at delivery and followed up through 9 months post partum). |
Onyango-Makumbi Conference on Retroviruses and Opportunistic Infections. February 2014, Boston, MA. Abs. 850 |
| Nguyen, 2014 | not relevant study design | EXCLUDED: inappropriate design: outcomes assessed according to the timing of cessation of treatment in post partum and not according to treatment received during pregnancy. |
Nguyen Aliment. Pharmacol. Ther. 2014; 39:1225-34 10.1111/apt.12726 |
| Aizire, 2020 | not relevant study design | EXCLUDED: analysis of severe adverse pregnancy/neonatal outcome according to TFV-DP concentrations. |
Aizire J. Acquir. Immune Defic. Syndr. 2020; 83:173-180 10.1097/QAI.0000000000002247 |
| Osorio, 2017 | not relevant study design | EXCLUDED: outcomes of infants receiving tenofovir during labor, post-natally or during labor and post-natally reported as a whole. |
Osorio Pediatr. Infect. Dis. J. 2017; 36:184-188 10.1097/INF.0000000000001386 |
| Callahan, 2015 | not relevant outcome | EXCLUDED: No specific data on the pregnancy outcomes ("Of the 115 women who became pregnant during the FEM-PrEP study with available outcome data, 30 (26.1%) reported some complications with no difference observed by study arm."). |
Callahan J. Acquir. Immune Defic. Syndr. 2015; 68:196-203 10.1097/QAI.0000000000000413 |
| Mirochnick, 2011 | not relevant outcome | EXCLUDED: continuous outcome (birth weight in grams). Substudy of IMPAACT P1025. |
Mirochnick J. Acquir. Immune Defic. Syndr. 2011; 56:412-9 10.1097/QAI.0b013e31820fd093 |
| Siberry, 2015 | not relevant outcome | EXCLUDED: continuous variables (bone mineral content). |
Siberry Clin. Infect. Dis. 2015; 61:996-1003 10.1093/cid/civ437 |
| Siberry, 2016 | not relevant outcome | EXCLUDED: continuous variables (Bone Mineral Content). |
Siberry 2016; Conference on Retroviruses and Opportunistic Infections; February 2016. Boston, MA. |
| Floridia, 2016 | not relevant outcome | EXCLUDED: for dichotomic variables: no unexposed group. An unexposed group is available for continuous variables only. |
Floridia J. Antimicrob. Chemother. 2016; 71:3206-3211 10.1093/jac/dkw268 |
| Jacobson, 2017 | not relevant outcome | EXCLUDED: analysis according to treatments only performed for continuous variables. |
Jacobson Pediatr. Infect. Dis. J. 2017; 36:189-197 10.1097/INF.0000000000001387 |
| Maskew, 2012 | not relevant outcome | EXCLUDED: not relevant outcome (incidence of pregnancy). | |
| Kourtis, 2018 | not relevant outcome | EXCLUDED: continuous variables (bone mineral content (BMC), bone mineral density (BMD) and whole body mass). |
Kourtis Pediatr. Infect. Dis. J. 2018; 37:e264-e268 10.1097/INF.0000000000002152 |
| Liotta, 2016 | not relevant outcome | EXCLUDED: continuous variables (growth). | |
| Gingelmaier, 2009 | not relevant outcome | EXCLUDED: continuous variables and there is no group with all pregnancies exposed to tenofovir (studied group: lamivudine or tenofovir/emtricitabine). | |
| Nozyce, 2014 | not relevant outcome | EXCLUDED: continuous outcomes (mean results to the WPPSI-III, WASI and WIAT-II-A tests). |
Nozyce Pediatr. Infect. Dis. J. 2014; 33:1128-33 10.1097/INF.0000000000000410 |
| Wang, 2016 | not relevant outcome | EXCLUDED: analysis of HBV Viremia at Delivery and CD4, which are more efficacy related outcomes than safety ones. |
Wang J. Infect. Dis. 2016; 214:1695-1699 10.1093/infdis/jiw439 |
| Sirois, 2013 | not relevant outcome | EXCLUDED: continuous outcome (mean score to the Bayley assessment). |
Sirois Pediatr. Infect. Dis. J. 2013; 32:648-55 10.1097/INF.0b013e318284129a |
| Chetty, 2016 | not relevant outcome | EXCLUDED: analysis of adherence to antiretroviral therapy and disease progression, without on fetal/neonatal/maternal safety data. | |
| Mora, 2012 | not relevant outcome | EXCLUDED: continuous variables (weight, length, tibial speed of sound, bone specific alkaline phosphatase...). | |
| Fernandez Ibieta, 2009 | repeat population groups, duplicate reports (most recent study included) | EXCLUDED: an update of these data (cohort that includes 8 public hospitals from Madrid) was published by Pietro 2014 on a longer period (2000-2009) and with more pregnancies. |
Fernandez Ibieta An Pediatr (Barc) 2009; 70:253-64 10.1016/j.anpedi.2008.10.021 |
| Jourdain, 2018 | same data already obtained by other studies | EXCLUDED: same study that Jourdain 2018 (New England Journal of Medicine). |
Jourdain, G. Obstetrical and Gynecological Survey 2018; 73:443-. 10.1097/OGX.0000000000000592 |
| Malaba, 2018 | same data already obtained by other studies | EXCLUDED: there is an overlapping between this study Malaba 2018 and Malaba 2017. Only Malaba 2018 was kept because more pregnancies were included. |
Malaba Ann Epidemiol 2018; 28:893-900 10.1016/j.annepidem.2018.08.011 |
| Sebikari, 2019 | same data already obtained by other studies | EXCLUDED: secondary analysis of data published by Fowler 2016. |
Sebikari Journal of Acquired Immune Deficiency Syndromes 2019; 81:521-532. |
| Venkatesh, 2019 | same data already obtained by other studies | EXCLUDED: subset of PROMISE trial women for neonates with both methods for measuring preterm: New Ballard Score and ultrasound. | |
| Morrison, 2015 | same data already obtained by other studies | EXCLUDED: The subanalysis published by Morrison 2015 (specifically related to seroconverter women) are probably included in the study published by Pintye 2017 and/or Heffron 2018. |
Morrison PLoS ONE 2015; 10:e0140773 10.1371/journal.pone.0140773 |
| Mhlanga, 2018 | no specific data | EXCLUDED: article of the feasibility to establish a pregnancy registry. No data on fetal/neonatal/maternal safety outcomes. |
Mhlanga HIV Clin Trials 2018; 19:8-14 10.1080/15284336.2017.1411419 |
| d'Arminio, 2014 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of naive versus ART-experienced women, without distinction between treatments. |
d'Arminio Monforte J. Acquir. Immune Defic. Syndr. 2014; 67:258-67 10.1097/QAI.0000000000000297 |
| Hofer, 2016 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis according to antiretroviral drugs (ARVs) as a whole, without distinction between treatments, excepted for WAZ, LAZ and WLZ (3 continuous variables). |
Hofer Pediatr. Infect. Dis. J. 2016; 35:71-7 10.1097/INF.0000000000000926 |
| Hoffman, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis according to antiretroviral therapy (ART) as a whole, without distinction between treatments. |
Hoffman Clin. Infect. Dis. 2019; 68:273-279 10.1093/cid/ciy471 |
| Liu, 2014 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis according to country, without analysis according to treatment. | |
| Baroncelli, 2009 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: for pregnancy outcomes: analysis for Antiretroviral treatment as a whole, without distinction between treatments. |
Baroncelli AIDS Patient Care STDS 2009; 23:513-20 10.1089/apc.2008.0263 |
| Gill, 2017 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis according to antiretroviral therapy as a whole, without distinction between treatments. |
Gill Medicine (Baltimore) 2017; 96:e9445 10.1097/MD.0000000000009445 |
| Stringer, 2018 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis according to group of antiretroviral therapy (NNRTI-based ART, PI-based ART or n NRTI-based ART) without distinction between treatments. |
Stringer PLoS ONE 2018; 13:e0199555 10.1371/journal.pone.0199555 |
| Hleyhel, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: cancers in infants reported according to antiretroviral regimens, but the number of pregnancies exposed to each antiretroviral regimen was not reported. |
Hleyhel Environ. Mol. Mutagen. 2019; 60:404-409 10.1002/em.22162 |
| Pinnetti, 2011 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of zidovudine-based HAART versus zidovudine-free regimens, without distinction between individual treatments in this latter. |
Pinnetti J. Infect. 2011; 63:144-50 10.1016/j.jinf.2011.06.001 |
| Favarato, 2018 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis performed for antiretroviral therapy class as a whole. OR also provided for the most frequently used antenatal antiretroviral regimens, but Tenofovir used as control group and raw data not provided. | |
| Tekin Koruk, 2015 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of tenofovir or lamivudine or telbivudine as a whole, without distinction between treatments. |
Tekin Koruk J. Obstet. Gynaecol. Res. 2015; 41:1870-6 10.1111/jog.12821 |
| Prieto, 2017 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Analysis of outcomes of HIV-1 infected pregnant women, as a whole without distinction between treatments (details on treatment provided for only some patients). |
Prieto PLoS ONE 2017; 12:e0183558 10.1371/journal.pone.0183558 |
| Jena, 2017 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of cirrhotic versus non cirrhotic pregnant women, without distinction between treatments. |
Jena J Obstet Gynaecol India 2017; 67:263-269 10.1007/s13224-016-0959-y |
| Campbell, 2012 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: no distinction in pregnancy outcomes of the 42 pregnancies exposed to EFV/FTC/TDF or EFV/3TC-ZDV. |
Campbell PLoS Med. 2012; 9:e1001290 10.1371/journal.pmed.1001290 |
| Reitter, 2013 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: fetal/neonatal/maternal outcomes provided according to antiretroviral regimens, but the number of pregnancies exposed for each antiretroviral regimen not mentionned. |
Reitter Infect Dis Obstet Gynecol 2013; 2013:208482 10.1155/2013/208482 |
| Livingston, 2007 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of Protease Inhibitors versus Nonprotease Inhibitors, without distinction between treatments. |
Livingston Obstet Gynecol 2007; 110:391-7 10.1097/01.AOG.0000271210.79340.4c |
| Ategeka, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: no analysis according to antiretroviral treatments. |
Ategeka PLoS ONE 2019; 14:e0215058 10.1371/journal.pone.0215058 |
| Radhika, 2017 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of Prevention of Parent To Child Transmission (PPTCT) and pregnancy outcomes according to years but not according to treatments. |
Radhika, A.G. Journal of Clinical and Diagnostic Research 2017; 11:QC04-. 10.7860/JCDR/2017/26432.10423 |
| Salazar-Austin, 2018 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis according to maternal disease status, without distinction between treatments. |
Salazar-Austin Clin. Infect. Dis. 2018; 66:921-929 10.1093/cid/cix851 |
| Patel, 2009 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of Antiretroviral therapy as a whole, without distinction between treatments. | |
| Msukwa, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis according to the timing of initiation of maternal combination antiretroviral therapy, without distinction between treatments. |
Msukwa Trop. Med. Int. Health 2019; 24:727-735 10.1111/tmi.13233 |
| Patel, 2010 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of antiretroviral therapy (with versus without PI) as a whole, without distinction between treatments. | |
| Chaudhury, 2017 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis according to in-utero exposure to HIV and associated ARVs, without distinction between treatments. | |
| El Agheb, 2015 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of pregnancies as a whole, without distinction between treatments (tenofovir or lamivudine). |
El Agheb Pan Afr Med J 2015; 20:316 10.11604/pamj.2015.20.316.6193 |
| Goetghebuer, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of (NRTI/PI), (NRTI/NNRTI) and (NRTI only) as a whole, without distinction between treatments. |
Goetghebuer Clin. Infect. Dis. 2019; 68:1193-1203 10.1093/cid/ciy673 |
| Garcia-Otero, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis according to HIV status without distinction between treatments. |
Garcia-Otero PLoS ONE 2019; 14:e0213279 10.1371/journal.pone.0213279 |
| Daver, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis according to antiretroviral therapy as a whole, without distinction between treatments. |
Daver, R.G. Journal of SAFOG 2019; 11:50-. 10.5005/jp-journals-10006-1649 |
| Lussiana, 2012 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of antiretroviral therapy as a whole, without distinction between treatments. |
Lussiana PLoS ONE 2012; 7:e36381 10.1371/journal.pone.0036381 |
| Boivin, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of triple antiretroviral prophylaxis without distinction between the 2 regimens (lopinavir–ritonavir plus either lamivudine and zidovudine or emtricitabine and tenofovir). |
Boivin Lancet HIV 2019; 6:e518-e530 10.1016/S2352-3018(19)30083-9 |
| Benhammou, 2018 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis according to illness statut, without analysis according to treatments. |
Benhammou J. Acquir. Immune Defic. Syndr. 2018; 77:439-450 10.1097/QAI.0000000000001618 |
| Moren, 2015 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of HIV-infected mothers and HIV-exposed infants as a whole, without distinction between treatments. | |
| Fouché, 2018 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis according to antiretroviral therapy as a whole, without distinction between treatments. |
Fouché J. Trop. Pediatr. 2018; 64:255-261 10.1093/tropej/fmx056 |
| Slogrove, 2017 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of HIV-exposed but uninfected (HEU) infants and HIV-unexposed (HU) infants, without analysis according to prenatal treatments. |
Slogrove Pediatr. Infect. Dis. J. 2017; 36:e38-e44 10.1097/INF.0000000000001391 |
| Springer, 2018 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis on neurodevelopmental outcome according to zidovudine antiretroviral exposure or combination antiretroviral therapy (cART), without distinction between individual treatments. |
Springer Trop. Med. Int. Health 2018; 23:69-78 10.1111/tmi.13006 |
| Massad, 2004 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of antiretroviral therapy as a whole, without distinction between treatments. | |
| Wedderburn, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of antiretrovirals as a whole, without distinction between treatments. |
Wedderburn Lancet Child Adolesc Health 2019; 3:803-813 10.1016/S2352-4642(19)30250-0 |
| Fan, 2014 | pattern of exposure | EXCLUDED: analysis of prescription pattern, without data on fetal/neonatal/maternal safety outcomes. |
Fan Infect Dis Obstet Gynecol 2014; 2014:546165 10.1155/2014/546165 |
| Floridia, 2012 | pattern of exposure | EXCLUDED: data on pattern of exposure, without fetal/neonatal/maternal safety data. |
Floridia AIDS Patient Care STDS 2012; 26:439-43 10.1089/apc.2012.0116 |
| Griner, 2011 | pattern of exposure | EXCLUDED: analysis of maternal use of ARVs during pregnancy, without fetal/neonatal/maternal safety outcomes. |
Griner AIDS Patient Care STDS 2011; 25:385-94 10.1089/apc.2011.0068 |
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