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3. Exposure to antiretroviral therapy in utero or early life: the health of uninfected children born to HIV-infected women

Author

Newell, ML, Giaquinto, C, Ruga, E, De Rossi, A, Grosch-Worner, I, Mok, J, Johnstone, F, de Jose, I, Bates, I, Salas, S, de Guevara, CL, Pena, JM, Garcia, JG, Lopez, JRA, Garcia-Rodriguez, MC, Asensi-Botet, F, Otero, MC, Perez-Tamarit, D, Ridaura, S, GREGORI, PIETRO, de la Torre, R, Scherpbier, H, Kreyenbroek, M, Boer, K, Bohlin, AB, Lindgren, S, Ehrnst, A, Belfrage, E, Naver, L, LEVY, JOHANNA, Barlow, P, Hainaut, M, Peltier, A, Wibaut, S, Ferrazin, A, Bassetti, D, DE MARIA, ANTONELLA, Gotta, C, Mur, A, Paya, A, Vinolas, M, Lopez-Vilchez, MA, Rovira, MA, Carreras, R, Valerius, NH, Coll, O, Vidal, R, PEREZ, JESUS MARIA, Boguna, J, Fortuny, C, Pardi, G, Ravizza, M, Guerra, B, Lanari, M, Bianchi, S, Bovicelli, L, Savasi, V, Vigano, A, Ferrazzi, E, BRAMBILLA, TERESA, Bianchi, L, Maccabruni, A, Taylor, GP, Lyall, EGH, Penn, Z, Buffolano, W, Martinelli, P, Sansone, M, Tibaldi, C, Marini, C, Masuelli, G, Benedetto, C, Niemiec, T, Marczynska, M, Newell, ML, Giaquinto, C, Ruga, E, De Rossi, A, Grosch-Worner, I, Mok, J, Johnstone, F, de Jose, I, Bates, I, Salas, S, de Guevara, CL, Pena, JM, Garcia, JG, Lopez, JRA, Garcia-Rodriguez, MC, Asensi-Botet, F, Otero, MC, Perez-Tamarit, D, Ridaura, S, Gregori, P, de la Torre, R, Scherpbier, H, Kreyenbroek, M, Boer, K, Bohlin, AB, Lindgren, S, Ehrnst, A, Belfrage, E, Naver, L, Levy, J, Barlow, P, Hainaut, M, Peltier, A, Wibaut, S, Ferrazin, A, Bassetti, D, De Maria, A, Gotta, C, Mur, A, Paya, A, Vinolas, M, Lopez-Vilchez, MA, Rovira, MA, Carreras, R, Valerius, NH, Coll, O, Vidal, R, Perez, JM, Boguna, J, Fortuny, C, Pardi, G, Ravizza, M, Guerra, B, Lanari, M, Bianchi, S, Bovicelli, L, Savasi, V, Vigano, A, Ferrazzi, E, Brambilla, T, Bianchi, L, Maccabruni, A, Taylor, GP, Lyall, EGH, Penn, Z, Buffolano, W, Martinelli, P, Sansone, M, Tibaldi, C, Marini, C, Masuelli, G, Benedetto, C, Niemiec, T, and Marczynska, M

Subjects
Europe, antiretroviral therapy, HIV, uninfected children, abnormalities
Abstract

Concerns have been raised over possible adverse effects of prophylactic antiretroviral therapy (ART) on the fetus and newborn. We analyzed data relating to uninfected children enrolled in the European Collaborative Study and investigated the association between ART exposure, perinatal problems, and major adverse health events later in life. Median length of follow-up was 2.2 (0-15.9) years. Of the 2414 uninfected children, 687 (28%) were exposed to ART in all three periods (antenatal, intrapartum, and neonatal). Of the 1008 infants exposed to ART at any time, 906 (90%) were exposed antenatally, 840 (83%) neonatally, and 750 (74%) both antenatally and neonatally. ART exposure was not significantly associated with pattern or prevalence of congenital abnormalities or low birth weight. In multivariate analysis, prematurity was associated with exposure to combination therapy without a protease inhibitor (PI) (OR = 2.66; 95% CI: 1.52-4.67) and with a PI (OR = 4.14; 95% CI: 2.36-7.23). ART exposure was associated with anemia in early life (P < .001). There was no evidence of an association with clinical manifestations suggestive of mitochondrial abnormalities. The absence of serious adverse events in this large cohort of uninfected children exposed to prophylactic ART in the short to medium term is reassuring.

Published
2004

4. Mode of delivery in HIV-infected pregnant women and prevention of mother-to-child transmission: changing practices in Western Europe

Author

Boer, K, England, K, Godfried, Mh, Thorne, C, Newell, Ml, Mahdavi, S, Giaquinto, Carlo, Rampon, O, Mazza, A, DE ROSSI, Anita, Worner, Ig, Mok, J, DE JOSE MI, Martinez, Bl, Pena, Jm, Garcia, Jg, Lopez, Jra, Rodriguez, Mcg, ASENSI BOTET, F, Otero, Mc, PEREZ TAMARIT, D, Scherpbier, Hj, Kreyenbroek, M, Nellen, Fjb, Naver, L, Bohlin, Ab, Lindgren, S, Kaldma, A, Belfrage, E, Levy, J, Barlow, P, Manigart, Y, Hainaut, M, Goetghebuer, T, Brichard, B, DE BRUYCKER JJ, Thiry, N, Waterloos, H, Viscoli, C, DE MARIA, A, Bentivoglio, G, Ferrero, S, Gotta, C, Mur, A, Paya, A, LOPEZ VILCHEZ MA, Carreras, R, Valerius, Nh, Rosenfeldt, V, Coll, O, Suy, A, Perez, Jm, Fortuny, C, Boguna, J, Savasi, V, Fiore, S, Crivelli, M, Vigano, A, Giacomet, V, Cerini, C, Raimondi, C, Zuccotti, G, Alberico, S, Tropea, M, Businelli, C, Taylor, Gp, Lyall, Egh, Penn, Z, Buffolano, W, Tiseo, R, Martinelli, P, Sansone, M, Maruotti, G, Agangi, A, Tibaldi, C, Marini, S, Masuelli, G, Benedetto, C, Niemiec, T, Marczynska, M, Dobosz, S, Popielska, J, Oldakowska, A, Malyuta, R, Semenenko, I, Pilipenko, T., Other Research, Obstetrics and Gynaecology, AII - Amsterdam institute for Infection and Immunity, General Internal Medicine, and Martinelli, Pasquale

Subjects
mode of delivery, HIV Infections, 0302 clinical medicine, prevention, Pregnancy, Antiretroviral Therapy, Highly Active, Pharmacology (medical), 030212 general & internal medicine, Young adult, Pregnancy Complications, Infectious, Substance Abuse, Intravenous, elective caesarean section, mode of delivery, mother-to-child transmission, prevention, 030219 obstetrics & reproductive medicine, pregnancy mother-to-child transmission, Vaginal delivery, Obstetrics, Health Policy, Prenatal Care, Viral Load, 3. Good health, Substance abuse, Europe, Infectious Diseases, Premature birth, Premature Birth, Reverse Transcriptase Inhibitors, Female, medicine.symptom, delivery, Viral load, Zidovudine, Adult, medicine.medical_specialty, elective caesarean section, Prenatal care, Article, 03 medical and health sciences, Young Adult, medicine, Humans, business.industry, Cesarean Section, mother-to-child transmission, HIV, Infant, Newborn, Infant, medicine.disease, Delivery, Obstetric, Infectious Disease Transmission, Vertical, Low birth weight, business, Epidemiologic Methods
Abstract

Objectives The aim of the study was to examine temporal and geographical patterns of mode of delivery in the European Collaborative Study (ECS), identify factors associated with elective caesarean section (CS) delivery in the highly active antiretroviral therapy (HAART) era and explore associations between mode of delivery and mother-to-child transmission (MTCT). Methods The ECS is a cohort study in which HIV-infected pregnant women are enrolled and their infants prospectively followed. Data on 5238 mother-child pairs (MCPs) enrolled in Western European ECS sites between 1985 and 2007 were analysed. Results The elective CS rate increased from 16% in 1985-1993 to 67% in 1999-2001, declining to 51% by 2005-2007. In 2002-2004, 10% of infants were delivered vaginally, increasing to 34% by 2005-2007. During the HAART era, women in Belgium, the United Kingdom and the Netherlands were less likely to deliver by elective CS than those in Italy and Spain [adjusted odds ratio (AOR) 0.07; 95% confidence interval (CI) 0.04-0.12]. The MTCT rate in 2005-2007 was 1%. Among MCPs with maternal HIV RNA

Published
2010

5. The mother-to-child HIV transmission epidemic in Europe: evolving in the East and established in the West

Author

Giaquinto, C, Rampon, O, D'Elia, R, De Rossi, A, Grosch Worner, I, Feiterna Sperling, C, Schmitz, T, Casteleyn, S, Mok, J., de Jose, I, Bates, I, Larru, B, Pena, Jm, Garcia, Jg, Lopez, Jra, Garcia Rodriguez MC, Asensi Botet, F, Otero, Mc, Perez Tamarit, D, Suarez, G, Scherpbier, H, Kreyenbroek, M, Godfried, Mh, Nellen, Fj, Boer, K, Bohlin, Ab, Lindgren, S, Belfrage, E, Naver, L, Anzen, B, Lidman, K, Levy, J, Hainaut, M, Goetghebuer, T, Manigart, Y, Barlow, P, Ferrazin, A, Bassetti, D, De Maria, A, Bentivoglio, G, Ferrero, S, Gotta, C, Mur, A, Paya, A, Lopez Vilchez MA, Carreras, R, Valerius, Nh, Jimenez, J, Coll, O, Suy, A, Perez, Jm, Fortuny, C, Boguna, J, Caro, Mc, Canet, Y, Pardi, G, Ravizza, M, Guerra, B, Lanari, M, Bianchi, S, Bovicelli, L, Prati, E, Duse, Marzia, Scaravelli, G, Stegagno, M, De Santis, M, Savasi, V, Ferrazzi, E, Vigano, A, Giacomet, V, Probizer, Fr, Maccabruni, A, Bucceri, A, Rancilio, L, Alberico, S, Rabusin, M, Bernardon, M, Taylor, Gp, Lyall, Egh, Penn, Z, Buffolano, W, Tiseo, R, Martinelli, P, Sansone, M, Agangi, A, Tibaldi, C, and Marini, S.

Published
2006

6. Mother-to-child transmission of HIV infection in the era of highly active antiretroviral therapy

Author

Giaquinto, Carlo, Ruga, EZIA MARIA, DE ROSSI, Anita, GROSCH WORNER, I, Mok, J, DE JOSE, I, Bates, I, Hawkins, F, DE GUEVARA CL, Pena, Jm, Garcia, Jg, Lopez, Jra, GARCIA RODRIGUEZ MC, ASENSI BOTET, F, Otero, Mc, PEREZ TAMARIT DP, Suarez, G, Scherpbier, H, Kreyenbroek, M, Boer, K, Bohlin, Ab, Lindgren, S, Ehrnst, A, Belfrage, E, Naver, L, Lidman, K, Anzen, B, Levy, J, Barlow, P, Hainaut, M, Peltier, A, Goetghebuer, T, Ferrazin, A, Bassetti, D, DE MARIA, A, Gotta, C, Mur, A, Paya, A, Vinolas, M, LOPEZ VILCHEZ MA, Rovira, Carreras, R, Valerius, Nh, Jimenez, J, Coll, O, Suy, A, Perez, Jm, Fortuny, C, Caro, Mc, Canet, Y, Savasi, V, Vigano, A, Ferrazi, E, Alberico, S, Rabusin, M, Bernardon, M, Taylor, Gp, Lyall, Egh, Penn, Z, Buffolano, W, Tiseo, R, Martinelli, P, Agangi, A, Sansone, M, Tibaldi, C, and Et, Al

Subjects
PERINATAL TRANSMISSION, HUMAN-IMMUNODEFICIENCY-VIRUS, RNA LEVELS, VERTICAL TRANSMISSION, CESAREAN DELIVERY, PREGNANT-WOMEN, PERINATAL TRANSMISSION, HUMAN-IMMUNODEFICIENCY-VIRUS, CESAREAN DELIVERY, RNA LEVELS, VERTICAL TRANSMISSION, PREGNANT-WOMEN
Published
2005

7. Increasing likelihood of further live births in HIV-infected women in recent years

Author

Giaquinto, Carlo, Ruga, EZIA MARIA, DE ROSSI, Anita, GROSCH WORNER, I, Mok, J, DE JOSE, I, Bates, I, Hawkins, F, DE GUEVARA CL, Pena, Jm, Garcia, Jg, Lopez, Jra, GARCIA RODRIGUEZ MC, ASENSI BOTET, F, Otero, Mc, PEREZ TAMARIT, D, Suarez, G, Scherpbier, H, Kreyenbroek, M, Boer, K, Bohlin, Ab, Lindgren, S, Belfrage, E, Naver, L, Anzen, B, Lidman, K, Levy, J, Barlow, P, Hainaut, M, Peltier, A, Goetghebuer, T, Ferrazin, A, Bassetti, D, DE MARIA, A, Gotta, C, Mur, A, Paya, A, LOPEZ VILCHEZ MA, Carreras, R, Valerius, Nh, Jimenez, J, Coll, O, Suy, A, Perez, Jm, Fortuny, C, Boguna, J, Caro, Mc, Canet, Y, Pardi, G, Ravizza, M, Guerra, B, Lanari, M, Bianchi, S, Bovicelli, L, Prati, E, Duse, M, Scaravelli, G, Stegagno, M, DE SANTIS, M, Semprini, Ae, Savasi, V, Vigano, A, Probizer, Fr, Maccabruni, A, Bucceri, A, Rancilio, L, Alberico, S, Rabusin, M, Bernardon, M, Taylor, Gp, Lyall, Egh, Penn, Z, Buffolano, Dw, Tiseo, R, Martinelli, P, Sansone, M, Tibaldi, C, Marini, S, Masuelli, G, Benedetto, C, Niemiec, T, Marczynska, M, Horban, A., Agangi, A., theEUROPEAN COLLABORATIVE, Study, and Martinelli, Pasquale

Subjects
medicine.medical_specialty, Time Factors, Population, HIV Infections, Logistic regression, ANTIRETROVIRAL THERAPY, Pregnancy, Antiretroviral Therapy, Highly Active, Hiv infected, medicine, Humans, Pregnancy Complications, Infectious, Prospective cohort study, education, Reproductive History, VERTICAL TRANSMISSION, Gynecology, education.field_of_study, business.industry, Obstetrics and Gynecology, Odds ratio, IMMUNODEFICIENCY-VIRUS TYPE-1, IMMUNODEFICIENCY-VIRUS TYPE-1, ANTIRETROVIRAL THERAPY, VERTICAL TRANSMISSION, Confidence interval, Parity, Female, Epidemiologic Methods, business, Live birth, Parity (mathematics), Maternal Age, Demography
Abstract

OBJECTIVE To examine how the subsequent childbearing of HIV-infected mothers enrolled in the European Collaborative Study (ECS) has changed over time and identify factors predictive of further childbearing. DESIGN Prospective cohort study. SETTING Centres in nine European countries included in the ECS, enrolled between end 1986 and November 2003. POPULATION HIV-infected women (3911): 3693 with only one and 218 with subsequent live births. METHODS Univariable and multivariable logistic regression analyses to obtain odds ratios (OR) and 95% confidence intervals (CI). Kaplan-Meier (KM) analyses to estimate cumulative proportions of women having a subsequent live birth. MAIN OUTCOME MEASURES Subsequent live birth. RESULTS In multivariable analysis adjusting for time period, ethnicity, maternal age and parity, black women were more likely [adjusted odds ratio (AOR) 2.45; 95% CI, 1.75-3.43], and women >30 years less likely (AOR 0.54, 0.37-0.80), to have a subsequent live birth. Time to subsequent live birth significantly shortened over time, with an estimated 2% of women having a subsequent live birth within 24 months of enrollment pre-1989 versus 14% in 2000-2003 (P < 0.001). Estimated time to subsequent live birth was shorter for black than for white women (P < 0.001). CONCLUSIONS The likelihood of subsequent live births substantially increased after 1995 and birth intervals were shorter in women on HAART and among black women. Numbers are currently too small to address the issue of advantages and disadvantages in the management of subsequent deliveries.

Published
2005

8. When do obstetricians recommend delivery for a high-risk preterm growth-retarded fetus? The GRIT Study Group. Growth Restriction Intervention Trial

Author

The GRIT Study Group, Danielian, P., Dawson, A., Whittle, M., Lilford, R. J., Tuffnell, D., Soothill, P., Beattie, B., Mires, G., Calder, A., Bashir, T., Lindow, S., Johal, W., Neales, K., Mason, G., Walker, J., Taylor, D., Narayan, H., Walkinshaw, S., Elder, M., Murphy, K., Manyonda, I., Bewley, S., Penn, Z., Rodeck, C., Griffiths, M., Maresh, M., Yousseff, H., Robson, S., Wiener, J., Hebblethwaite, N., Jenkinson, S., Fairlie, F., Fraser, R., Stewart, W., Johanson, R., James, D., Sengupta, B. S., Saunders, N., Cameron, H., Churchill, D., Bober, S., Heard, M., Welch, R., Pring, D., Gleeson, R., Jenkins, D., van Geijn, H., Amsterdam, V. U., Wolf, H., Visser, G., van Loon, A., van der Lugt, B., van der Slikke, J. W., van Roosmalen, J., Karpathios, S., Todros, Tullia, Frusca, T., Montanari, L., Ferrazzi, E., Garzetti, G., Tranquilli, A., Di Tommaso, R., Locci, M. V., Roncaglia, N., Tenore, A. C., Centini, G., Bricchi, G., Genazzani, A. R., Streda, R., Gjelland, K., Heikkila, A., Vasco, E., and Martin, T.

Subjects
Fetal Growth Retardation, Time Factors, Pregnancy, High-Risk, Infant, Newborn, Gestational Age, Pilot Projects, Intervention, Failure to thrive, Delivery, Obstetric, Umbilical Arteries, Pregnancy Complications, Preterm fetus, Intervention, Failure to thrive, Pregnancy, Laser-Doppler Flowmetry, Humans, Female, Preterm fetus, Infant, Premature
Abstract

Forty-nine obstetricians from three European countries were asked when they would advise delivery for a preterm fetus failing to thrive in utero, given various gestational ages, and a range of either umbilical artery Doppler flow velocity waveforms or CTG variability measures. Their responses indicated a wide area of disagreement about the correct timing of delivery, and a willingness to randomize patients to clinical trials of management. The area of uncertainty corresponded to the gestational age and Doppler bands at which participants have been entered to the pilot phase of a randomised trial of timed delivery, the Growth Restriction Intervention Trial (GRIT).

Published
1996

9. Levels and patterns of HIV RNA viral load in untreated pregnant women

Author

Patel, D, Thorne, C, Newell, Ml, CORTINA BORJA, M, Giaquinto, Carlo, Rampon, O, D'Elia, R, DE ROSSI, Anita, GROSCH WORNER, I, Mok, J, DE JOSE MI, Martinez, Bl, Pena, Jm, Garcia, Jg, Lopez, Jra, GARCIA RODRIGUEZ, J, ASENSI BOTET, F, Otero, Mc, PEREZ TAMARIT, D, Scherpbier, Hj, Kreyenbroek, M, Godfried, Mh, Nellen, Fjb, Boer, K, Ehrnst, A, Bohlin, Ab, Lindgren, S, Anzen, B, Lidman, K, Levy, J, Barlow, P, Manigart, Y, Hainaut, M, Goetghebuer, T, Ferrazin, A, Viscoli, C, DE MARIA, A, Bentivoglio, G, Ferrero, S, Gotta, C, Mur, A, Paya, A, LOPEZ VILCHEZ MA, Carreras, R, Valerius, Nh, Rosenfeldt, V, Jimenez, J, Coll, O, Suy, A, Perez, Jm, Fortuny, C, Boguna, J, Caro, Mc, Canet, Y, Ravizza, M, Guerra, B, Lanari, M, Bianchi, S, Bovicelli, L, Prati, E, Duse, M, Scaravelli, G, Stegagno, M, DE SANTIS, M, Savasi, V, Fiore, S, Crivelli, M, Ferrazzi, E, Vigano, A, Giacomet, V, Cerini, C, Raimondi, C, Zuccotti, G, Probizer, Fr, Maccabruni, A, Bucceri, A, Rancilio, L, Alberico, S, Rabusin, M, Bernardon, M, Taylor, Gp, Lyall, Egh, Penn, Z, Buffolano, W, Tiseo, R, Martinelli, A, Sansone, M, Maruotti, G, Agangi, A, Tibaldi, C, Marini, S, Masuelli, G, Benedetto, C, Niemiec, T, Marczynska, M, Dobosz, S, Popielska, J, Oldakowska, A, Malyuta, R, Semenenko, I, Pilipenko, T, Posokhova, S, Kaleeva, T, Stelmah, A, Kiseleva, G., European Collaborative Study, Patel D, Thorne C, Newell ML, Cortina-Borja M [, Guerra B, Lanari M ], Amsterdam institute for Infection and Immunity, Paediatric Infectious Diseases / Rheumatology / Immunology, General Internal Medicine, Infectious diseases, Other Research, and Obstetrics and Gynaecology

Subjects
Microbiology (medical), Adult, medicine.medical_specialty, Race, Adolescent, Black People, Gestational Age, HIV Infections, Disease, White People, HIV, Pregnancy, HIV RNA viral load, ART-naïve, Young Adult, Asian People, pregnancy, Medicine, Humans, Young adult, Pregnancy Complications, Infectious, business.industry, Obstetrics, Confounding, RNA, Gestational age, General Medicine, Viral Load, medicine.disease, CD4 Lymphocyte Count, hiv, art-naïve, hiv rna viral load, race, art-naive, Infectious Diseases, Immunology, HIV-1, RNA, Viral, Female, Sample collection, business, Viral load
Abstract

Objective: To assess pregnancy levels and patterns of HIV RNA in the absence of antiretroviral therapy, while appropriately adjusting for potential confounders, including maternal immune status and race. Methods: Data on >= 1 antenatal HIV RNA measurements were available for 333 untreated HIV-infected pregnant women enrolled in the European Collaborative Study. CD4 counts and HIV RNA measurements were routinely collected from 1992 and 1998, respectively. Linear mixed effects models based on 246 women for whom complete data were available examined changes in HIV RNA levels over pregnancy, with a nested random effects term accounting for measurement variability within women and period of sample collection. Results: The change in HIV RNA over pregnancy varied significantly by race (p = 0.005): from the second trimester until delivery, HIV RNA decreased significantly by an estimated 0.019 log(10) copies/ml/week in white women (95% Cl -0.03, -0.007); in black women the estimated 0.016 log(10) copies/ml/week increase (95% Cl -0.005, 0.037) was not statistically significant. At delivery, HIV RNA levels in black women were 0.45 log(10) copies/ml higher (95% Cl 0.08, 0.83) than in white women. Conclusions: Our findings suggest that HIV RNA dynamics over pregnancy differ by race, although other interpretations cannot be excluded, due to potential for unmeasured confounding. (C) 2008 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved

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12. Simultaneous intrapartum uterine and bladder rupture.

Author

Oteng-Ntim E, Iskaros J, Dinneen M, and Penn Z

Subjects
Adult, Female, Humans, Pregnancy, Rupture, Spontaneous, Urinary Bladder Diseases pathology, Urinary Bladder Diseases surgery, Uterine Rupture pathology, Uterine Rupture surgery, Obstetric Labor Complications, Urinary Bladder Diseases etiology, Uterine Rupture etiology, Vaginal Birth after Cesarean adverse effects
Published
2002
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14. Elective or selective caesarean delivery of the small baby? A systematic review of the controlled trials.

Author

Grant A, Penn ZJ, and Steer PJ

Subjects
Anesthesia, Obstetrical, Apgar Score, Breech Presentation, Elective Surgical Procedures, Female, Humans, Pregnancy, Randomized Controlled Trials as Topic, Cesarean Section adverse effects, Cesarean Section statistics & numerical data, Obstetric Labor, Premature surgery
Abstract

Objective: To compare a policy of elective caesarean delivery with a policy of selective caesarean delivery for women in spontaneous preterm labour., Design: Systematic review of relevant randomised controlled trials., Participants: One hundred and twenty-two women from six trials., Interventions: Random allocation to "intention to deliver by caesarean section' (elective caesarean policy), compared with "intention to deliver vaginally' (selective caesarean policy)., Main Outcome Measures: Actual use of caesarean delivery, low Apgar score, neonatal intubation, intracranial pathology, perinatal death, and major maternal complications., Results: One in six women in both groups were not delivered as allocated. Typical odds ratios for all adverse neonatal outcomes tended to favour the elective group, but for all outcomes studied the confidence intervals were wide and did not exclude clinically important hazards of the policy. The odds of serious maternal morbidity were increased in the caesarean section group (OR 6.2; 95% CI 1.3-30.1)., Conclusion: A policy of elective caesarean delivery increases the risks of maternal morbidity, but it remains unclear whether these are offset by benefits for the infant.

Published
1996
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15. A multicentre randomised controlled trial comparing elective and selective caesarean section for the delivery of the preterm breech infant.

Author

Penn ZJ, Steer PJ, and Grant A

Subjects
Adult, Elective Surgical Procedures, Female, Humans, Infant Mortality, Infant, Newborn, Pregnancy, Pregnancy Outcome, Breech Presentation, Cesarean Section, Obstetric Labor, Premature
Abstract

Objective: To determine the optimum mode of delivery for women in preterm breech labour at a gestational age of 26 to 32 weeks., Design: A multicentre randomised controlled trial., Setting: Twenty-six hospitals in England, UK., Participants: Women with a singleton breech fetus in spontaneous preterm labour between 26 and 32 completed weeks of gestation, with no clear indication for a caesarean section or vaginal breech delivery., Intervention: Random allocation to either "intention to delivery vaginally' or "intention to deliver by caesarean section'., Main Outcome Measures: Perinatal mortality, neonatal morbidity, maternal morbidity and gestation at delivery., Results: The trial was closed after 17 months because of low recruitment, by which time substantial numbers of women had been in the eligible gestation period. Thirteen women from six hospitals were recruited. One infant, randomised to and delivered vaginally, was stillborn. Three fetal presentations were cephalic at delivery despite a diagnosis of breech presentation at trial entry. No formal statistical analysis was performed due to the small numbers., Conclusions: No conclusions about the optimum mode of delivery for women in preterm labour with a fetus presenting by the breech can be drawn from this trial. The low accrual rate was due to clinicians' reluctance to randomise eligible women, reflecting the circumstances and nature of the trial.

Published
1996
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17. How obstetricians manage the problem of preterm delivery with special reference to the preterm breech.

Author

Penn ZJ and Steer PJ

Subjects
England, Female, Fetal Monitoring statistics & numerical data, Gestational Age, Humans, Pregnancy, Surveys and Questionnaires, Wales, Breech Presentation, Cesarean Section statistics & numerical data, Obstetric Labor, Premature therapy
Abstract

A questionnaire regarding the route of birth for the preterm fetus with particular reference to the management of the preterm breech was sent to 180 consultants in England and Wales. Only 23% of respondents use electronic fetal monitoring below 26 weeks gestation and only 12% use caesarean section routinely for fetal indications at less than 26 weeks. Only 12% will use caesarean section for the preterm fetus presenting by the vertex in uncomplicated labour. Only 35% of all respondents consider that there is sufficient evidence to support the use of caesarean section for the uncomplicated preterm breech, but 76% will actually use caesarean section for this indication. Overall 71% reported that they are affected by medicolegal considerations in their management of the preterm breech. Overall, 83% said that they might change their practice regarding the mode of delivery of the preterm breech in the light of the findings of a randomized prospective controlled trial.

Published
1991
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18. Reasons for declining participation in a prospective randomized trial to determine the optimum mode of delivery of the preterm breech.

Author

Penn ZJ and Steer PJ

Subjects
Cesarean Section, Feasibility Studies, Female, Humans, Infant, Newborn, Informed Consent, Pregnancy, Prospective Studies, United Kingdom, Breech Presentation, Delivery, Obstetric, Infant, Premature, Randomized Controlled Trials as Topic methods
Abstract

Increasing numbers of preterm breech infants are being delivered by cesarean section, which confers no proven advantage to the infant and subjects the mother to increased risk. In order to assess the feasibility of performing a randomized controlled trial to compare elective with selective cesarean delivery for the preterm breech infant, consultants in 36 hospitals were asked if they would be willing to participate. In 25 hospitals all consultants agreed to participate, whereas in 11 universal support was not obtained. The reasons given for nonparticipation included the potentially time-consuming nature of the consent procedure, which it was proposed should be undertaken with all women during the antenatal period, concern that a large proportion of non-English speak women would not be able to give truly informed consent, anxiety about the seniority, availability, and requisite skill of the personnel delivering the preterm breech, doubts about the details of the protocol, medicolegal considerations, and disagreement about the desirability of the trial among the consultant members of a department. If prospective evaluation of clinical practice is to be carried out in the future the staffing levels of obstetric departments must taken into account the additional work load that this entails.

Published
1990
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