A randomised trial to compare 200 mg micronised progesterone effervescent vaginal tablet daily with 250 mg intramuscular 17 alpha hydroxy progesterone caproate weekly for prevention of recurrent preterm birth

References

• Abd El Hameed AA. 2012. Vaginal versus intramuscular progesterone in the prevention of preterm labor and their effect on uterine and fetal blood flow. Middle East Fertility Society Journal 17:163–169.
   Google Scholar
• ACOG Committee Opinion number 419 October 2008 (replaces no. 291, November 2003). Use of progesterone to reduce preterm birth. Obstetrics and Gynecology 112:963–965.
   PubMedGoogle Scholar
• Bafghi AS, Bahrami E, Sekhavat L. 2015. Comparative study of vaginal versus intramuscular progesterone in the prevention of preterm delivery: a randomized clinical trial. Electronic Physician 7:1301–1309.
   PubMedGoogle Scholar
• Berghella V, Blackwell S, Anderson B, Chauhan SP, Copel J, Gyamfi C. 2012. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. American Journal of Obstetrics and Gynecology 206:376–386.
   PubMed Web of Science ®Google Scholar
• Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB. As the born too soon preterm birth action group. 2013. Born too soon: the global epidemiology of 15 million preterm births. Reproductive Health 10:S2.
   PubMed Web of Science ®Google Scholar
• Bourgain C, Devroey P, Van Waesberghe L, Smitz J, Van Steirteghem AC. 1990. Effects of natural progesterone on the morphology of the endometrium in patients with primary ovarian failure. Human Reproduction (Oxford, England) 5:537–543.
   PubMed Web of Science ®Google Scholar
• Bulletti C, de Ziegler D, Flamigni C, Giacomucci E, Polli V, Bolelli G, et al. 1997. Targeted drug delivery in gynaecology: the first uterine pass effect. Human Reproduction (Oxford, England) 12:1073–1079.
   PubMed Web of Science ®Google Scholar
• Cicinelli E, de Ziegler D, Bulletti C, Matteo MG, Schonauer LM, Galatino P. 2000. Direct transport of progesterone from vagina to uterus. Obstetrics and Gynecology 95:403–406.
   PubMed Web of Science ®Google Scholar
• Cicinelli E, Schonauer LM, Galantino P, Matteo MG, Cassetta R, Pinto V. 2000. Mechanisms of uterine specificity of vaginal progesterone. Human Reproduction 15:159–165.
   PubMed Web of Science ®Google Scholar
• Da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M. 2003. 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. American Journal of Obstetrics and Gynecology 188:419–424.
   PubMed Web of Science ®Google Scholar
• De Ziegler D, Bulletti C, De Monstier B, Jaaskelainen AS. 1997. The first uterine pass effect. Annals of the New York Academy of Sciences 828:291–299.
   PubMed Web of Science ®Google Scholar
• Dodd JM, Jones L, Flenady V, Cincotta R, Crowther CA. 2013. Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth. Cochrane Database systematic reviews 7:CD004947.
   PubMed Web of Science ®Google Scholar
• El-Gharib MN, El-Hawary TM. 2013. Matched sample comparison of intramuscular versus vaginal micronized progesterone for prevention of preterm birth. Journal of Maternal Fetal and Neonatal Medicine 26:716–719.
   PubMed Web of Science ®Google Scholar
• Elimian A, Smith K, Williams M, Knudtson E, Goodman JR, Escobedo MB. 2016. A randomized controlled trial of intramuscular versus vaginal progesterone for the prevention of recurrent preterm birth. International Journal of Gynaecology and Obstetrics: The Official Organ of the International Federation of Gynaecology and Obstetrics 134:169–172.
   PubMed Web of Science ®Google Scholar
• Farine D, Mundle WR, Dodd J. 2008. The use of progesterone for prevention of preterm birth. Journal of Obstetrics and Gynaecology Canada 30:67–77.
   PubMedGoogle Scholar
• Levy T, Gurevitch S, Bar-Hava I, Ashkenazi J, Magazanik A, Homburg R, et al. 1999. Pharmacokinetics of natural progesterone administered in the form of a vaginal tablet. Human Reproduction (Oxford, England) 14:606–610.
   PubMed Web of Science ®Google Scholar
• Luo G, Abrahams VM, Tadesse S, Funai EF, Hodgson EJ, Gao J, Norwitz ER. 2010. Progesterone inhibits basal and TNF-alpha-induced apoptosis in fetal membranes: a novel mechanism to explain progesterone-mediated prevention of preterm birth. Reproductive Sciences (Thousand Oaks, Calif.) 17:532–539.
   PubMed Web of Science ®Google Scholar
• Mackenzie R, Walker M, Armson A, Hannah ME. 2006. Progesterone for the prevention of preterm birth among women at increased risk: a systematic review and meta-analysis of randomized controlled trials. American Journal of Obstetrics and Gynecology 194:1234–1242.
   PubMed Web of Science ®Google Scholar
• Maher MA, Abdelaziz A, Ellaithy M, Bazeed MF. 2013. Prevention of preterm birth: a randomized trial of vaginal compared with intramuscular progesterone. Acta Obstetricia Et Gynecologica Scandinavica 92:215–222.
   PubMed Web of Science ®Google Scholar
• Majhi P, Bagga R, Kalra J, Sharma M. 2009. Intravaginal use of natural micronised progesterone to prevent pre-term birth: a randomised trial in India. Journal of Obstetrics and Gynaecology: The Journal of the Institute of Obstetrics and Gynaecology 29:493–498.
   PubMedGoogle Scholar
• Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, et al. 2003. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. New England Journal of Medicine 348:2379–2385.
   PubMed Web of Science ®Google Scholar
• Mesiano S, Wang X, Norwitz ER. 2011. Progesterone receptors in the human pregnancy uterus: do they hold the key to birth timing? Reproductive Sciences 18:6–19.
   PubMed Web of Science ®Google Scholar
• Miles RA, Paulson RJ, Lobo RA, Press MF, Dahmoush L, Sauer MV. 1994. Pharmacokinetics and endometrial tissue levels of progesterone after administration by intramuscular and vaginal routes: a comparative study. Fertility and Sterility 62:485–490.
   PubMed Web of Science ®Google Scholar
• Norman JE, Marlow N, Messow C-M, Shennan A, Bennett PR, Thornton S, et al. 2016. Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial. Lancet (London, England) 387:2106–2116.
   PubMed Web of Science ®Google Scholar
• Norwitz ER, Caughey AB. 2011. Progesterone supplementation and the prevention of preterm birth. Reviews in Obstetrics and Gynecology 4:60–72.
   PubMedGoogle Scholar
• Norwitz ER, Wilson T. 2000. Secretory component: a potential regulator of endometrial-decidual prostaglandin production in early human pregnancy. American Journal of Obstetrics and Gynecology 183:108–117.
   PubMed Web of Science ®Google Scholar
• O’Brien JM, Adair CD, Lewis DF, Hall DR, DeFranco EA, Fusey S. 2007. Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial. Ultrasound in Obstetrics and Gynecology 30:687–696.
   PubMed Web of Science ®Google Scholar
• Pasquale SA, Foldesy RG, Levine JP, Bachmann GA, Blackwell RE. 1997. Peripheral progesterone (P) concentrations and endometrial response to various dosages of vaginally administered P in estrogen-primed women. Fertility and Sterility 68:810–815.
   PubMed Web of Science ®Google Scholar
• Paulson RJ, Collins MG, Yankov VI. 2014. Progesterone pharmacokinetics and pharmacodynamics with 3 dosages and 2 regimens of an effervescent micronized progesterone vaginal insert. The Journal of Clinical Endocrinology and Metabolism 99:4241–4249.
   PubMed Web of Science ®Google Scholar
• Rode L, Langhoff-Roos J, Andersson C, Dinesen J, Hammerum MS, Mohapeloa H, Tabor A. 2009. Systematic review of progesterone for the prevention of preterm birth in singleton pregnancies. Acta Obstetricia Et Gynecologica Scandinavica 88:1180–1189.
   PubMed Web of Science ®Google Scholar
• Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O’Brien JM, Cetingoz E. 2012. 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. American Journal of Obstetrics and Gynecology 206:124.e1–119.
   PubMed Web of Science ®Google Scholar
• Saccone G, Khalifeh A, Elimian A, Bahrami E, Chaman-Ara K, Bahrami MA, Berghella V. 2017. Vaginal progesterone vs intramuscular 17α-hydroxyprogesterone caproate for prevention of recurrent spontaneous preterm birth in singleton gestations: systematic review and meta-analysis of randomized controlled trials. Ultrasound in Obstetrics and Gynecology: The Official Journal of the International Society of Ultrasound in Obstetrics and Gynecology 49:315–321.
   PubMed Web of Science ®Google Scholar
• Sanchez-Ramos L, Kaunitz AM, Delke I. 2005. Progestational agents to prevent preterm birth: a meta-analysis of randomized controlled trials. American Journal of Obstetrics and Gynecology 105:273–279.
   Web of Science ®Google Scholar
• Smitz J, Devroey P, Faguer B, Bourgain C, Camus M, Van Steirteghem AC. 1992. A prospective randomized comparison of intramuscular or intravaginal natural progesterone as a luteal phase and early pregnancy supplement. Human Reproduction (Oxford, England) 7:168–175.
   PubMed Web of Science ®Google Scholar
• Tavaniotou A, Smitz J, Bourgain C, Devroey P. 2000. Comparison between different routes of progesterone administration as luteal phase support in infertility treatments. Human Reproduction Update 6:139–148.
   PubMed Web of Science ®Google Scholar
• The Royal Australian and New Zealand College of Obstetricians & Gynaecologists (RANZCOG). 2013. Progesterone: use in the second and third trimester of pregnancy for the prevention of preterm birth. Melbourne, Australia: RANZCOG.
   Google Scholar
• US Department of Health and Human Services, Food & Drug Administration. 2007. Statement on Endometrin; [cited 2016 Mar 20]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022057s000_Approv.pdf\
   Google Scholar
• US Department of Health and Human Services, Food and Drug Administration. 2013. Statement on Makena [press release] Silver Spring, MD; [cited 2016 Mar 20]. Available from: www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm402614.htm
   Google Scholar
• Zakar T, Hertelendy F. 2007. Progesterone withdrawal: key to parturition. American Journal of Obstetrics and Gynecology 196:289–296.
   PubMed Web of Science ®Google Scholar