Authors
1 Associate Professor of Obstetrics & Gynecology, Afzalipour School of Medicince, Kerman University of Medical Sciences, Kerman, Iran
2 Resident of Obstetrics & Gynecology, Afzalipour School of Medicince, Kerman University of Medical Sciences, Kerman, Iran
Abstract
Background & Aims: Preterm premature rupture of membranes (PPROM) is the leading cause of preterm birth and perinatal mortality and morbidity, and complications. The objective of the present study was to assess the effect of progesterone agents (rectal suppositories and weekly injection of 17- hydroxyprogesterone caproate) on latency period in women with PPROM. Methods: This randomized, double-blind study included 171 pregnant women with PPROM between 24 and 34 weeks of gestation. The participants were randomized into 3 groups; 17-hydroxyprogesterone caproate (n = 57), rectal progesterone (n = 57), no treatment (n = 102). The first group was administered rectal progesterone 400 mg daily, second group 17-hydroxyprogesterone caproate 250 mg weekly, and the third group was not administered any medicine. The 3 groups were followed until delivery. All groups were compared in terms of latency period duration, gestational age and weight at delivery, chorioamnionitis, neonatal infections, neonatal and fetal mortality, and sepsis. Data analysis was performed using SPSS, chisquare and Kruskal-Wallistests. Results: Gestational age at the time of rupture of membranes (P = 0.664) and parity (P = 0.275) were similar in the 3 groups. The duration of the latency period was significantly longer among the progesterone groups (P = 0.006) compared with the no treatment group. The 3 groups were significantly different in terms of gestational age at delivery (P = 0.378), mode of delivery (P = 0.845), birth weight (P = 0.185), admission at neonatal intensive-care unit )NICU( (P = 0.336), and chorioamnionitis prevalence (P = 0.915). Conclusion: Progesterone agents may prolong the latency period in women with PPROM, but its effect on pregnancy outcome is uncertain. Further randomized trials are required to determine the effect of this treatment on pregnancy outcome
Keywords
- Melamed N, Hadar E, Ben-Haroush A, Kaplan B, Yogev Y. Factors affecting the duration of the latency period in preterm premature rupture of membranes. J Matern Fetal Neonatal Med 2009; 22(11): 1051-6.
- The American College of Obstetricians and Gynecologists. Clinical management guidelines for obstetrician-gynecologists [Online]. [cited 2014 Oct]; Available from: URL: http://www.acog.org/-/media/List%20of%20Titles/PBListOfTitles.pdf
- Lieman JM, Brumfield CG, Carlo W, Ramsey PS. Preterm premature rupture of membranes: is there an optimal gestational age for delivery? Obstet Gynecol 2005; 105(1): 12-7.
- Sfakianaki AK, Norwitz ER. Mechanisms of progesterone action in inhibiting prematurity. J Matern Fetal Neonatal Med 2006; 19(12): 763-72.
- Peltier MR, Tee SC, Smulian JC. Effect of progesterone on proinflammatory cytokine production by monocytes stimulated with pathogens associated with preterm birth. Am J Reprod Immunol 2008; 60(4): 346-53.
- Norman JE, Shennan A, Bennett P, Thornton S, Robson S, et al. Trial protocol OPPTIMUM- does progesterone prophylaxis for the prevention of preterm labour improve outcome? BMC Pregnancy Childbirth 2012; 6(12): 79.
- Test G, Levy A, Wiznitzer A, Mazor M, Holcberg G, Zlotnik A, et al. Factors affecting the latency period in patients with preterm premature rupture of membranes. Arch Gynecol Obstet 2011; 283(4): 707-10.
- da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol 2003; 188(2): 419-24.
- Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med 2003; 348(24): 2379-85.
- Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med 2007; 357(5): 462-9.
- Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, et al. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol 2012; 206(2): 124-19.
- O'Brien JM, Adair CD, Lewis DF, Hall DR, Defranco EA, Fusey S, et al. Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 2007; 30(5): 687-96.
- Briery CM, Veillon EW, Klauser CK, Martin RW, Magann EF, Chauhan SP, et al. Women with preterm premature rupture of the membranes do not benefit from weekly progesterone. Am J Obstet Gynecol 2011; 204(1): 54-5.
- How HY, Cook CR, Cook VD, Miles DE, Spinnato JA. Preterm premature rupture of membranes: aggressive tocolysis versus expectant management. J Matern Fetal Med 1998; 7(1): 8-12.
- Maymon E, Chaim W, Sheiner E, Mazor M. A review of randomized clinical trials of antibiotic therapy in preterm premature rupture of the membranes. Arch Gynecol Obstet 1998; 261(4): 173-81.
- Defranco EA, O'Brien JM, Adair CD, Lewis DF, Hall DR, Fusey S, et al. Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: a secondary analysis from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 2007; 30(5): 697-705.
- Spong CY, Meis PJ, Thom EA, Sibai B, Dombrowski MP, Moawad AH, et al. Progesterone for prevention of recurrent preterm birth: impact of gestational age at previous delivery. Am J Obstet Gynecol 2005; 193(3 Pt 2): 1127-31.
- Tita AT, Rouse DJ. Progesterone for preterm birth prevention: an evolving intervention. Am J Obstet Gynecol 2009; 200(3): 219-24.
- Gonzalez-Quintero VH, Cordova YC, Istwan NB, Tudela F, Rhea DJ, Romary LM, et al. Influence of gestational age and reason for prior preterm birth on rates of recurrent preterm delivery. Am J Obstet Gynecol 2011; 205(3): 275.
- Sotiriadis A, Papatheodorou S, Makrydimas G. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis. Ultrasound Obstet Gynecol 2012; 40(3): 257-66.
- Dodd JM, Flenady V, Cincotta R, Crowther CA. Prenatal administration of progesterone for preventing preterm birth (Review). Hoboken, New Jersey: John Wiley & Sons; 2007.
- Dodd JM, Crowther CA, Cincotta R, Flenady V, Robinson JS. Progesterone supplementation for preventing preterm birth: a systematic review and meta-analysis. Acta Obstet Gynecol Scand 2005; 84(6): 526-33.
- Lotfalizadeh M, Ghomian N, Reyhani A. The effects of progesterone therapy on the gestation length and reduction of neonatal complications in patients who had received tocolytic therapy for acute phase of preterm labor. Iran Red Crescent Med J 2013; 15(10): e7947.
- Ngai I, Marji M, Neto N, Garretto D, Sheen JJ, Garry DJ. The effectiveness of 17alpha-hydroxyprogesterone caproate in obese women for prevention of preterm delivery. Obstet Gynecol 2014; 123(Suppl 1): 161S-2S.
- Ngai I, Sheen JJ, Garretto D, Govindappagari S, Bernstein P, Garry DJ. Progesterone (17alpha-hydroxyprogesterone caproate) for prevention of preterm birth and preeclampsia. Obstet Gynecol 2014; 123(Suppl 1): 162S.
)