Vaginal delivery in women with HIV in Italy: results of 5 years of implementation of the national SIGO-HIV protocol
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To evaluate the maternal and neonatal safety of vaginal delivery in women with HIV following the implementation of a national protocol in Italy.
Vaginal delivery was offered to all eligible women who presented antenatally at twelve participating clinical sites. Data collection and definition of outcomes followed the procedures of the National Program on Surveillance on Antiretroviral Treatment in Pregnancy. Pregnancy outcomes were compared according to the mode of delivery, classified as vaginal, elective cesarean (ECS) and non-elective cesarean section (NECS).
Among 580 women who delivered between January 2012 and September 2017, 142 (24.5%) had a vaginal delivery, 323 (55.7%) had an ECS and 115 (19.8%) had an NECS. The proportion of vaginal deliveries increased significantly over time, from 18.9% in 2012 to 35.3% in 2017 (p < 0.001). Women who delivered vaginally were younger, more commonly nulliparous, diagnosed with HIV during current pregnancy, and antiretroviral-naïve, but had a slightly longer duration of pregnancy, with significantly higher birthweight of newborns. NECS was associated with adverse pregnancy outcomes. The rate of HIV transmission was minimal (0.4%). There were no differences between vaginal and ECS about delivery complications, while NECS was more commonly associated with complications compared to ECS.
Vaginal delivery in HIV-infected women with suppressed viral load appears to be safe for mother and children. No cases of HIV transmission were observed. Despite an ongoing significant increase, the rate of vaginal delivery remains relatively low compared to other countries, and further progress is needed to promote this mode of delivery in clinical practice.
KeywordsHIV Pregnancy Mode of delivery Delivery complications
We thank all participating clinical sites and Marco Floridia and Cosimo Polizzi of the Istituto Superiore di Sanità in Rome, Italy, for providing technical support for this study. No compensation was received for this contribution. SIGO-HIV Study Group: C. Tibaldi, T. Todros, G. Masuelli, V. Frisina (Department of Gynaecology and Obstetrics, Turin University,Città della Salute e della Scienza Hospital, Turin). L. Trentini (Department of Infectious Diseases, Turin University, Amedeo di Savoia Hospital, Turin). B. Tassis, G. Tiso (Obstetric and Gynecology Unit, Milan University, IRCCS Ospedale Maggiore Policlinico Foundation, Milan). I. Cetin, T. Brambilla, V. Savasi, C. Personeni (Department of Obstetrics and Gynaecology, Milan University, Luigi Sacco Hospital, Milan,). G. Zuccotti, V. Giacomet, S. Coletto, F. Di Nello, C. Madia (Pediatric Clinic, Milan University, Luigi Sacco Hospital, Milan). L. Franceschetti, (Department of Obstetrics and Gynecology, Brescia University, ASST Spedali Civili, Brescia), M. A. Forleo, (Department of Infectious and Tropical Diseases, Brescia University, ASST Spedali Civili, Brescia), R. Badolato (Pediatrics Clinic and Institurte for Molecular Medicine A. Nocivelli, Department of Clinical and Experimental Sciences, Uiversity of Brescia, ASST Spedali Civili, Brescia). A. Spinillo, M. Roccio (IRCCS S. Matteo and Department of Obstetrics and Ginaecology, Pavia University), D. Zanaboni (Infectious Diseases IRCCS S. Matteo, Pavia). M. Sansone, P. Martinelli, A. Sirico, G. M. Maruotti, A. Capone (Department of Neurosciences, Reproductive and Dentistry Science, University Federico II, Naples). G. Simonazzi, B. Guerra, F. Cervi, E. Margarito, (Department of Medical and Surgical Sciences, Bologna University, Policlinico Sant’Orsola-Malpighi, Bologna). M. G. Capretti, C. Marsico, G. Faldella (Preventive Pediatrics and Neonatology Clinical Institute, Policlinico Sant’Orsola-Malpighi, Bologna). A. Vimercati, F.M. Crupano, D. Calabretti. M. Ravizza, A.M. Marconi, S. Dalzero, V. Galiano, Sara Charlotte Simonetti M. Ierardi, (Department of Obstetrics and Gynaecology, Milan University, ASST Santi Paolo e Carlo Hospital Medical School,Milan). A. Meloni, A. Chiodo (Division of Gynaecology and Obstetrics, Cagliari University, S. Giovanni di Dio Hospital, Cagliari), F. Ortu, P. Piano (Clinical Immunology, S. Giovanni di Dio Hospital, Cagliari), I. M. Dedoni (Pathology and Neonatal Intensive Care Unit, Cagliari). M. Bernardon, G. Maso, C. Belcaro, E. Rizzante, S. Alberico (Institute for Maternal and Child Healh IRCCS Burlo Garofolo, Trieste). A. Citernesi, I. Bordoni Vicini, K. Luzi, (USL 4, Prato).
CT conceived the idea for the study and managed the project. CT, PM, MR and MF designed the study. CT, GM, MS, BT, IC, LF, AS, GS, AV, SD, AM, MB, VF, TT, PM and MR substantially contributed to acquisition of data. MF and CP were responsible for statistical analysis. CT and MF drafted and finalised the manuscript. All the authors gave final approval to the final version to be published.
Compliance with ethical standards
Conflict of interest
On behalf of all authors, the corresponding author states that there is no conflict of interest.
The study protocol (“Protocollo di Parto vaginale in pazienti HIV+ in terapia antiretrovirale altamente attiva (HAART) con carica virale non dosabile e CD4+ > 200/mm3 stabili da almeno 4 settimane al momento del parto”) obtained central ethics approval on November 30, 2011 (OIRM/S. Anna—Ordine Mauriziano di Torino Ethics Committee, ref. 54081/C28.2) and was subsequently approved by the Ethics Committee of each participating center (Twelve centers, listed in acknowledgements). Data collection used the forms and procedures of the National Program on Surveillance on Antiretroviral Treatment in Pregnancy (Ethics approval: ref. no. 578/2001 from the Ethics Committee of the I.N.M.I. Lazzaro Spallanzani in Rome).
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