The effect of rectal progesterone on latency period as well as maternal and prenatal outcome between 24 to 33 weeks
DOI:
https://doi.org/10.18203/2349-3259.ijct20151239Keywords:
Preterm premature rupture of membranes, Pregnancy prolongation, ProgesteroneAbstract
Preterm Premature Rupture Of Membranes (PPROM) is directly linked to prematurity associated with severe neonatal morbidity and mortality. Randomized clinical trials have shown that weekly injections of 17-alpha-hydroxyprogesterone (17P) or daily vaginal progesterone application decreases the number of preterm deliveries, particularly for women with a history of preterm delivery or those with a shortened cervix. However, no studies have yet been conducted to prove or disprove the effect of rectal progesterone on latency period. To address this issue, we will conduct a multicenter randomized triple-blind controlled trial of 216 participants (108 in each group) from January 1, 2016 to August 31, 2016. Inclusion criteria, exclusion criteria, data collection procedure, data analysis, and assessment of safety procedures are explained in the study protocol. The primary objective will be to determine the effect of rectal progesterone on the latency period in PPROM. The secondary objective will be to study the effect of rectal progesterone on maternal outcomes of hospitalization, intensive care unit admission, chorioamnionitis, post-partum hemorrhage, post-partum pyrexia, endometritis, and maternal death. In addition, we will evaluate prenatal birth weight, Apgar score, neonatal morbidity, duration of neonatal intensive care unit stay, intrauterine fetal death, and neonatal death associated with PPROM.References
American College of Obstetricians and Gynecologists. Clinical management of preterm premature rupture of the membranes. Obstet Gynecol. 1998;1:848-57.
Mercer BM. Preterm premature rupture of the membranes. Obstet Gynecol. 2003;101:178-93.
Lieman JM, Brumfield CG, Carlo W, Ramsey PS. Preterm premature rupture of membranes: is there an optimal gestational age for delivery? Obstet Gynecol. 2005;105:12-7.
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;348:2379-85.
Da Fonseca EB, Bittar RE, Carvalho MH, Sugaib 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;188:419-24.
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. Obstet Gynecol. 2007;30:697-705.
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;60:346-53.
Veillon EW, Keiser SD, Parrish MR, Bennett W, Cockrell K, Ray LF, et al. 17-Hydroxyprogesterone blunts the hypertensive response associated with reductions in uterine perfusion pressure in pregnant rats. Am J Obstet Gynecol. 2009;201:324.
Elovitz MA, Mrinalini C. Can medroxyprogesterone acetate alter Toll-like receptor expression in a mouse model of intrauterine inflammation? Am J Obstet Gynecol. 2005;193:1149-55.
Sfakianaki AK, Norwitz ER. Mechanisms of progesterone action in inhibiting prematurity. J Matern Fetal Neonatal Med. 2006;19:763-72.
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;204:54.
Cicinelli E, de Ziegler D, Bulletti C, Matteo MG, Schonauer LM, Galantino P. Direct transport of progesterone from vagina to uterus. Obstet Gynecol. 2000;95(3):403-6.
Einer-Jensen N, Hunter R. Counter-current transfer in reproductive biology. Reproduction. 2005;129(1):9-18.
Aghsa MM, Rahmanpour H, Bagheri M, Davari-Tanha F, Nasr R. A randomized comparison of the efficacy, side effects and patient convenience between vaginal and rectal administration of Cyclogest® when used for luteal phase support in ICSI treatment. Arch Gynecol Obstet. 2012;286(4):1049-54.
Yee W, Amin H, Wood S. Elective Cesarean delivery, neonatal intensive care unit admission, and neonatal respiratory distress. Obstet Gynecol. 2008;111(4):823-8.
Volpe JJ. Neurology of the newborn. In: Volpe JJ, eds. A Book. 3rd ed. Philadelphia, PA: WB Saunders; 1995.
Guthrie SO, Gordon PV, Thomas V, Thorp JA, Peabody J, Clark RH. Necrotizing enterocolitis among neonates in the United States. J Perinatol. 2003;23:278-85.
Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001;163:1723-9.
Lwanga SK, Lemeshow S. Sample size determination in health studies: a practical manual. Geneva: World Health Organization; 1991: 38-39.
Kenyon SL, Taylor DJ, Tarnow-Mordi W. Broad-spectrum antibiotics for preterm, prelabor rupture of fetal membranes: the ORACLE I randomised trial. Lancet. 2001;357(9261):979-88.
Alexander GR, Himes JH, Kaufman RB, Mor J, Kogan M. A United States national reference for fetal growth. Obstet Gynecol. 1996;87:163-8.
American College of Obstetricians and Gynecologists. Premature rupture of membranes. Obstet Gynecol. 2007;109:1007-19.
Sweet RL, Gibbs RS. Chorioamnionitis. In: Sweet RL, Gibbs RS, eds. Infectious Diseases of the Female Genital Tract. 3rd ed. Baltimore, MD: Lippincott Williams & Wilkins; 1995: 554.
Duley L, Meher S, Abalos E. Management of pre-eclampsia. BMJ. 2006;332(7539):463-8.
NICE. Hypertension in pregnancy - the management of hypertensive disorders during pregnancy. NICE clinical guideline 107, 2011. Available at: guidance.nice.org.uk/cg107. Accessed 1 January 2011.
Crawford P. Effectiveness of cinnamon for lowering hemoglobin A1C in patients with type 2 diabetes: a randomized, controlled trial. J Am Board Fam Med. 2009;22(5):507-12.
Mercer BM, Miodovnik M, Thurnau GR, Goldenberg RL, Das AF, Ramsey RD, et al. Antibiotic therapy for reduction of infant morbidity after preterm premature rupture of membranes: a randomized controlled trial. JAMA. 1997;278:989-95.
Combs CA, Garite T, Maurel K, Mallory K, Edwards R, Lu G, et al. 17-Hydroxyprogesterone caproate to prolong pregnancy after preterm rupture of the membranes: early termination of a double-blind, randomized clinical trial. BMC Res Notes 2011;4(1):568.
