Quality of Informed Consent Practices around the Time of Childbirth: A Cross-Sectional Study in Italy
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Study Setting and Population
2.3. Data Collection and Variables
2.4. Data Analysis
3. Results
3.1. Sample Characteristics
3.2. Frequency of Consent Requests (as Reported by Women)
3.3. Quality of Information Delivered by Health Workers Prior to Consent Requests
3.4. Quality of the Communication and Women Autonomy
3.5. Women Characteristics Associated with Consent Request
3.6. Health Workers’ Perspectives on Organisational Factors and Availability of Resources for Consent Request
3.7. Health Workers’ Perspectives on Causes of Ineffective Communication
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Women | n (N = 1244) | % |
Age < 35 years old | 735 | 59.1 |
Age ≥ 35 years old | 509 | 40.9 |
Bachelor’s degree/specialist degree | 655 | 52.6 |
Italian nationality | 1124 | 90.3 |
Born in Italy | 1051 | 84.5 |
Employed women | 987 | 79.3 |
Primiparous | 658 | 52.9 |
Single pregnancy | 1223 | 98.3 |
Newborn NICU admission | 145 | 11.7 |
Women highly satisfied with care received (score ≥ 7) | 1047 | 84.2 |
Frequency of nine key procedures under study 1 | N | % |
Maternal care | ||
Vaginal examination during labour | 1094 | 87.9 |
Kristeller manoeuvre 2 | 130 | 10.5 |
Episiotomy | 166 | 13.3 |
Instrumental vaginal birth | 120 | 9.6 |
Caesarean section | 285 | 22.9 |
PPH prophylaxis 3 | 959 | 77.1 |
Neonatal care | ||
Neonatal conjunctivitis prophylaxis | 1244 | 100 |
Neonatal haemorrhagic disease prophylaxis (Vitamin K) | 1244 | 100 |
Neonatal screening for metabolic diseases | 1244 | 100 |
Health workers | n (N = 105) | % |
Gender: female | 93 | 88.6 |
Profession | ||
Midwife | 36 | 34.3 |
Nurse | 27 | 25.7 |
Obstetrician | 15 | 14.3 |
Neonatologist | 9 | 8.6 |
Undergraduate students/medical residents | 18 | 17.1 |
More than 10 years of work in maternal and newborn care | 54 | 51.9 |
Women Informed Both on Risks and Benefits and Reasons for the Procedures n (%) | Incomplete Information 2 n (%) | No Information for Both Practices n (%) | Not Remembered by Women for Both Practices n (%) | |
---|---|---|---|---|
Kristeller manoeuvre 1 (N = 129) | 24 (18.6) | 50 (38.8) | 39 (30.2) | 16 (12.4) |
Episiotomy (N = 166) | 65 (39.2) | 71 (42.7) | 22 (13.3) | 8 (4.8) |
Instrumental vaginal birth (N = 119) | 45 (37.8) | 49 (41.2) | 13 (10.9) | 12 (10.1) |
Caesarean sections (N = 285) | 249 (87.4) | 34 (11.8) | 1 (0.4) | 1 (0.4) |
Yes n (%) | Partially Yes n (%) | I Do Not Remember/I Am Not Sure n (%) | No n (%) | |
---|---|---|---|---|
Availability of adequate protocols for consent | 71 (67.6) | 16 (15.2) | 8 (7.6) | 7 (6.7) |
Availability of adequate standard consent forms | 82 (78.1) | 19 (18.1) | 2 (1.9) | 0 |
Presence of adequate in-service hospital training and supportive supervision for consent request | 33 (31.4) | 35 (33.3) | 7 (6.7) | 27 (25.7) |
Existence of mechanisms to identify an event where women could not express an informed choice | 21 (20.0) | 8 (7.6) | 53 (50.5) | 15 (14.3) |
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Valente, E.P.; Mariani, I.; Covi, B.; Lazzerini, M. Quality of Informed Consent Practices around the Time of Childbirth: A Cross-Sectional Study in Italy. Int. J. Environ. Res. Public Health 2022, 19, 7166. https://doi.org/10.3390/ijerph19127166
Valente EP, Mariani I, Covi B, Lazzerini M. Quality of Informed Consent Practices around the Time of Childbirth: A Cross-Sectional Study in Italy. International Journal of Environmental Research and Public Health. 2022; 19(12):7166. https://doi.org/10.3390/ijerph19127166
Chicago/Turabian StyleValente, Emanuelle Pessa, Ilaria Mariani, Benedetta Covi, and Marzia Lazzerini. 2022. "Quality of Informed Consent Practices around the Time of Childbirth: A Cross-Sectional Study in Italy" International Journal of Environmental Research and Public Health 19, no. 12: 7166. https://doi.org/10.3390/ijerph19127166
APA StyleValente, E. P., Mariani, I., Covi, B., & Lazzerini, M. (2022). Quality of Informed Consent Practices around the Time of Childbirth: A Cross-Sectional Study in Italy. International Journal of Environmental Research and Public Health, 19(12), 7166. https://doi.org/10.3390/ijerph19127166