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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2017

Open Access 01-12-2017 | Research article

Progesterone in women with arrested premature labor, a report of a randomised clinical trial and updated meta-analysis

Authors: Stephen Wood, Yacov Rabi, Selphee Tang, Rollin Brant, Susan Ross

Published in: BMC Pregnancy and Childbirth | Issue 1/2017

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Abstract

Background

Progesterone may be effective in prevention of premature birth in some high risk populations. Women with arrested premature labor are at risk of recurrent labor and maintenance therapy with standard tocolytics has not been successful.

Methods

Randomized double blinded clinical trial of daily treatment with 200 mg vaginal progesterone in women with arrested premature labor and an updated meta-analysis.

Results

The clinical trial was terminated early after 41 women were enrolled. Vaginal progesterone treatment did not change the median gestational age at delivery: 36+2 weeks versus 36+4 weeks, p = .865 nor increase the mean latency to delivery: 44.5 days versus 46.6 days, p = .841. In the updated meta-analysis, progesterone treatment did reduce delivery <37 weeks gestation and increase latency to delivery, but this treatment effect was not evident in the high quality trials: (OR 1.23, 95% CI 0.91, 1.67) and (−0.95 days, 95% CI −5.54, 3.64) respectively.

Conclusion

Progesterone is not effective for preventing preterm birth following arrested preterm labor.
Appendix
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Literature
1.
Berkman N, Thorp JM, Lohr KN, Carey TS, Hartmann KE, Gavin NI, et al. Tocolytic treatment for the management of preterm labor: A review of the evidence. Am J Obstet Gynecol. 2003;188:1648–59.CrossRefPubMed
2.
Naik GN, Raman P, Bain E, Crowther CA. Maintenance therapy with calcium channel blockers for preventing preterm birth after threatened preterm labour. Cochrane Database Syst Rev. 2004;10:CD004071.
3.
Humphrey RG, Bartfield MC, Carlan SJ, O’Brien WF, O’Leary TD, Triana T. Sulindac to prevent recurrent preterm labor: a randomized controlled trial. Obstet Gynecol. 2001;98(4):555–62.PubMed
4.
Papatsonis DN, Flenady V, Liley HG. Maintenance therapy with oxytocin antagonists for inhibiting preterm birth after threatened preterm labour. Cochrane Database Syst Rev. 2013;10:CD005938.
5.
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.CrossRefPubMed
6.
Meis PJ, Klebanoff MA, 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.CrossRefPubMed
7.
Ross S, Milne J, Dwinnell S, Tang S, Wood S. Effect size needed to introduce progesterone and cervical cerclage into clinical practice to prevent premature birth. BMC Med Res Methodol. 2012;12(31)
8.
9.
Tan PC, King AS, Vallikkannu N, Omar SZ. Single dose 17 alpha-hydroxyprogesterone caproate in preterm labor: a randomized trial. Arch Gynecol Obstet. 2012;285(3):585–90.CrossRefPubMed
10.
Chawanpaiboon S, Pimol K, Sirisomboon R. Comparison of success rate of nifedipine, progesterone, and bed rest for inhibiting uterine contraction in threatened preterm labor. J Obstet Gynaecol Res. 2011;37(7):787–91.CrossRefPubMed
11.
Saghafi N, Khadem N, Mohajeri T, Shakeri MT. Efficacy of 17alpha-hydroxyprogesterone caproate in prevention of preterm delivery. J Obstet Gynaecol Res. 2011;37(10):1342–5.CrossRefPubMed
12.
Noblot G, Audra P, Dargent D, Faguer B, Mellier G. The use of micronized progesterone in the treatment of menace of preterm delivery. Eur J Obstet Gynecol Reprod Biol. 1991;40(3):203–9.CrossRefPubMed
13.
Choudhary M, Suneja A, Vaid NB, Guleria K, Faridi MM. Maintenance tocolysis with oral micronized progesterone for prevention of preterm birth after arrested preterm labor. Int J Gynaecol Obstet. 2014;126(1):60–3.CrossRefPubMed
14.
Rozenberg P, Chauveaud A, Deruelle P, Capelle M, Winer N, Desbriere R, et al. Prevention of preterm delivery after successful tocolysis in preterm labor by 17 alpha-hydroxyprogesterone caproate: a randomized controlled trial. Am J Obstet Gynecol. 2012;206(3):206–9.CrossRefPubMed
15.
Facchinetti F, Paganelli S, Comitini G, Dante G, Volpe A. Cervical length changes during preterm cervical ripening: effects of 17-alpha-hydroxyprogesterone caproate. Am J Obstet Gynecol 421. 2007;196(5):453–4.
16.
Briery CM, Klauser CK, Martin RW, Magann EF, Chauhan SP, Morrison JC. The use of 17-hydroxy progesterone in women with arrested preterm labor: a randomized clinical trial. J Matern Fetal Neonatal Med. 2014;27(18):1892–6.CrossRefPubMed
17.
Martinez De TB, Karolinski A, Ocampo MC, Laterra C, Hosli I, Fernandez D, et al. Prevention of preterm delivery with vaginal progesterone in women with preterm labour (4P): randomised double-blind placebo-controlled trial. BJOG Int J Obstet Gynaecol. 2015;122(1):80–91.CrossRef
18.
Sharami SH, Zahiri Z, Shakiba M, Milani F. Maintenance therapy by vaginal progesterone after threatened idiopathic preterm labor: A randomized placebo-controlled double-blind trial. Int J Fertil Steril. 2010;4(2):45–50.
19.
Palacio M, Cobo T, Antolin E, Ramirez M, Cabrera F, De Rosales FM et al. Vaginal progesterone as maintenance treatment after an episode of preterm labor (PROMISE Study): A randomized, double blinded, placebo-controlled trial. Am J Obstet Gynecol. 2013;Conference(var.pagings):S10–S11.
20.
Kamat S, Veena P, Rani R. Comparison of nifedipine and progesterone for maintenance tocolysis after arrested preterm labour. J Obstet Gynaecol. 2014;34(4):322–5.CrossRefPubMed
21.
Borna S, Sahabi N. Progesterone for maintenance tocolytic therapy after threatened preterm labour: a randomised controlled trial. Aust N Z J Obst Gynaecol. 2008;48(1):58–63.CrossRef
22.
Areia A, Fonseca E, Moura P. Progesterone use after successful treatment of threatened pre-term delivery. J Obstet Gynaecol. 2013;33:678–81.CrossRefPubMed
23.
Gargari SS, Habibolahi M, Zonobi ZKZ, Sarfjoo FS, Robati AK, Etemad R, et al. Outcome of Vaginal Progesterone as a Tocolytic Agent: Randomized Clinical Trial. ISRN Obstet Gynecol. 2012;2012:607906.
24.
Lotfalizadeh M, Ghomian N, Reihani 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.CrossRefPubMedPubMedCentral
25.
Suhag A, Saccone G, Berghella V. Vaginal progesterone for maintenance tocolysis: a systematic review and metaanalysis of randomized trials. Am J Obstet Gynecol. 2015;213:479–87.CrossRefPubMed
26.
Odgaard-Jensen J, Vist GE, Timmer A, Kunz R, Akl EA, Schunemann H, et al. Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev. 2011;4:MR000012.
27.
Herbison P, Hay-Smith J, Gillespie WJ. Different methods of allocation to groups in randomized trials are associated with different levels of bias. A meta-epidemiological study. J Clin Epidemiol. 2011;64(10):1070–5.CrossRefPubMed
28.
Savovic J, Jones HE, Altman DG, Harris RJ, Juni P, Pildal J, et al. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med. 2012;157(6):429–38.CrossRefPubMed
Metadata
Title
Progesterone in women with arrested premature labor, a report of a randomised clinical trial and updated meta-analysis
Authors
Stephen Wood
Yacov Rabi
Selphee Tang
Rollin Brant
Susan Ross
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2017
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-017-1400-y

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