Download PDF
CC BY-NC-ND 4.0 · AJP Rep 2020; 10(03): e198-e201
DOI: 10.1055/s-0040-1713788
Original Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Effectiveness of Progestogens as Maintenance Tocolysis and Urogenital Cultures: Secondary Analysis of the PROTECT Trial

Lucrezia Pignatti 
1   Department of Mother Infant, Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia, Modena, Italy
,
Roberto D'Amico
2   Department of Diagnostic, Clinical and Public Health Medicine, Statistics Unit, University of Modena and Reggio Emilia, Modena, Italy
,
Patrizia Vergani
3   Department of Medicine and Surgery, Obstetrics Gynecology Branch, University of Milano-Bicocca Health Science, Milano, Lombardia, Italy
,
Mariarosaria Di Tommaso
4   Department of Health Science, Obstetrics and Gynecology Branch, University of Florence, Florence, Italy
,
Barbara Acaia
5   Obstetrics and Gynecology Unit, Istituto di Ricovero e Cura a Carattere Scientifico Policlinico, Milan, Italy
,
Chiara Benedetto
6   Department of Surgical Sciences, Gynaecology and Obstetrics, University of Turin, Turin, Piemonte, Italy
,
Fabio Facchinetti
1   Department of Mother Infant, Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia, Modena, Italy
› Author Affiliations
Further Information

Publication History

03 September 2019

06 April 2020

Publication Date:
04 August 2020 (online)

Also available at
   Permissions and Reprints

Abstract

Background In a recently published multicenter randomized controlled trial, we demonstrated that progestogens are not effective as maintenance tocolysis.

Objective This study was aimed to evaluate if previous finding may be affected by positive urine culture and/or vaginal swab.

Study Design We performed a secondary analysis of the PROTECT trial (NCT01178788). Women with singleton pregnancy between 22 and 31 6/7 weeks' gestation, admitted for threatened preterm labor were considered. At admission, we collected urine culture and vaginal swabs. At discharge, women with a cervical length ≤25 mm were randomized to vaginal progesterone or 17α-hydroxyprogesterone caproate or observation group. We used Chi-square statistics, considering 97.5% CI (confidence interval) and p-value less than 0.025 for significance.

Results Urine culture and vaginal swabs were collected in 232 out of 235 patients included in the primary analysis. Overall, 31 out of 232 women (13.4%) had positive urine culture and 60 out of 232 (25.9%) had positive vaginal swab. In women with negative urine culture, a higher rate of preterm birth was found in vaginal progesterone group (27/69, 39.7%) respect with controls (14/68, 20.6%; relative risk [RR] = 1.90; 97.5% CI: 1.01–3.57; p = 0.018).

Conclusion Among women with negative urine culture, the rate of preterm birth <37 weeks' gestation was significantly increased in those receiving vaginal progesterone, reinforcing our previous findings in symptomatic women.

Keywords

preterm labor - progestogens - maintenance tocolysis - genitourinary infection
 

  • References

  • 1 Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet 2008; 371 (9606): 75-84
    CrossrefPubMedGoogle Scholar
  • 2 Romero R, Espinoza J, Kusanovic JP. , et al. The preterm parturition syndrome. BJOG 2006; 113 (Suppl. 03) 17-42
    CrossrefPubMedGoogle Scholar
  • 3 Kalinderi K, Delkos D, Kalinderis M, Athanasiadis A, Kalogiannidis I. Urinary tract infection during pregnancy: current concepts on a common multifaceted problem. J Obstet Gynaecol 2018; 38 (04) 448-453
    CrossrefPubMedGoogle Scholar
  • 4 Sheiner E, Mazor-Drey E, Levy A. Asymptomatic bacteriuria during pregnancy. J Matern Fetal Neonatal Med 2009; 22 (05) 423-427
    CrossrefPubMedGoogle Scholar
  • 5 Garland SM, Ní Chuileannáin F, Satzke C, Robins-Browne R. Mechanisms, organisms and markers of infection in pregnancy. J Reprod Immunol 2002; 57 (1,2): 169-183
    CrossrefPubMedGoogle Scholar
  • 6 Cunnington M, Kortsalioudaki C, Heath P. Genitourinary pathogens and preterm birth. Curr Opin Infect Dis 2013; 26 (03) 219-230
    CrossrefPubMedGoogle Scholar
  • 7 Facchinetti F, Vergani P, Di Tommaso M. , et al. Progestogens for maintenance tocolysis in women with a short cervix: a randomized controlled trial. Obstet Gynecol 2017; 130 (01) 64-70
    CrossrefPubMedGoogle Scholar
  • 8 Suhag A, Saccone G, Berghella V. Vaginal progesterone for maintenance tocolysis: a systematic review and metaanalysis of randomized trials. Am J Obstet Gynecol 2015; 213 (04) 479-487
    CrossrefPubMedGoogle Scholar
  • 9 Palacio M, Ronzoni S, Sánchez-Ramos L, Murphy KE. Progestogens as maintenance treatment in arrested preterm labor: a systematic review and meta-analysis. Obstet Gynecol 2016; 128 (05) 989-1000
    CrossrefPubMedGoogle Scholar
  • 10 Smaill FM, Vazquez JC. Antibiotics for asymptomatic bacteriuria in pregnancy. Cochrane Database Syst Rev 2015; (08) CD000490
    PubMedGoogle Scholar
  • 11 Romero R, Oyarzun E, Mazor M, Sirtori M, Hobbins JC, Bracken M. Meta-analysis of the relationship between asymptomatic bacteriuria and preterm delivery/low birth weight. Obstet Gynecol 1989; 73 (04) 576-582
    PubMedGoogle Scholar
  • 12 National Institute for Health and Care Excellence. Antenatal care for uncomplicated pregnancies. Available at: https://www.nice.org.uk/guidance/cg62 . Accessed April 20, 2020
    PubMedGoogle Scholar
  • 13 Pararas MV, Skevaki CL, Kafetzis DA. Preterm birth due to maternal infection: causative pathogens and modes of prevention. Eur J Clin Microbiol Infect Dis 2006; 25 (09) 562-569
    CrossrefPubMedGoogle Scholar
  • 14 Romero R, Espinoza J, Gonçalves LF, Kusanovic JP, Friel L, Hassan S. The role of inflammation and infection in preterm birth. Semin Reprod Med 2007; 25 (01) 21-39
    Article in Thieme ConnectPubMedGoogle Scholar
  • 15 Larsen B, Hwang J. Progesterone interactions with the cervix: translational implications for term and preterm birth. Infect Dis Obstet Gynecol 2011; 2011: 353297
    CrossrefPubMedGoogle Scholar
  • 16 Hung TH, Chen SF, Wu CP, Li MJ, Yeh YL, Hsieh TT. Micronized progesterone pretreatment affects the inflammatory response of human gestational tissues and the cervix to lipopolysaccharide stimulation. Placenta 2017; 57: 1-8
    CrossrefPubMedGoogle Scholar