Vaginal micronized progesterone and risk of preterm delivery in high‐risk twin pregnancies: secondary analysis of a placebo‐controlled randomized trial and meta‐analysis

Klein, Katharina; Rode, Line; Nicolaides, Kypros H.; Krampl-Bettelheim, Elisabeth; Tabor, Ann

doi:10.1002/uog.9092

Cited by 65 publications

(51 citation statements)

References 28 publications

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“…To date, progesterone has not been shown to be beneficial in unselected twin pregnancies 16 -19 . Data on twins with cervical shortening are limited to secondary analyses of randomized controlled trials 20,21 . These studies failed to show a benefit of progesterone but lack sufficient power.…”

Section: Discussionmentioning

confidence: 99%

Gestational age at cervical length measurement and preterm birth in twins

Ehsanipoor

Haydon

Gaffaney³

et al. 2012

Ultrasound in Obstet & Gyne

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Objectives (odds ratio (OR) 0.95 (95% CI,; P < 0.001) and by approximately 6% for each additional week at which the cervical length was measured (OR 0.94 (95% CI,; P < 0.001). ConclusionThe gestational age at which cervical length is measured is an important consideration when estimating the risk of spontaneous preterm birth in twins. The risk of preterm delivery is increased at earlier gestational ages and as cervical length decreases.

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Section: Discussionmentioning

confidence: 99%

Gestational age at cervical length measurement and preterm birth in twins

Ehsanipoor

Haydon

Gaffaney³

et al. 2012

Ultrasound in Obstet & Gyne

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“…29 Nevertheless, it is difficult to draw conclusions because the number of women with twin pregnancies analysed in all of these studies was relatively small and the definition of a short cervix was not uniform. 5,15,28,29 In our trial, we had a very low incidence of women with a previous preterm delivery and/or a short cervix ( Table 1).…”

Section: Vaginal Progesterone In Twin Pregnanciesmentioning

confidence: 92%

“…Although it has been suggested that the mechanisms underlying the parturition process in twins may differ from those in singletons, 28 this has not yet been proven. The different sensitivities to progestogen supplementation depending on the risk factors also suggest that there may be more than one pathway leading to spontaneous preterm labour.…”

Section: Vaginal Progesterone In Twin Pregnanciesmentioning

confidence: 98%

“…Three secondary analyses of randomised trials showed that intramuscular 17P and vaginal natural progesterone did not decrease the risk of preterm birth in twin pregnancies with either a short cervix or a previous history of preterm birth. 5,15,28 However, a recent meta-analysis showed that vaginal progesterone was associated with a non-significant reduction in the rate of preterm birth, but effectively reduced the composite neonatal morbidity/mortality of women with twin gestations and a short cervix. 29 Nevertheless, it is difficult to draw conclusions because the number of women with twin pregnancies analysed in all of these studies was relatively small and the definition of a short cervix was not uniform.…”

Section: Vaginal Progesterone In Twin Pregnanciesmentioning

confidence: 99%

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Increased doses of vaginal progesterone for the prevention of preterm birth in twin pregnancies: a randomised controlled double‐blind multicentre trial

Serra¹,

Perales²,

Meseguer³

et al. 2012

BJOG

100

110

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Objective Previous trials have shown little benefit for preventing preterm birth in twin pregnancies using 90-200 mg of daily vaginal natural progesterone. Higher doses have not been tested. Our aim was to determine the efficacy and safety of two different daily doses of vaginal natural progesterone (200 and 400 mg), compared with placebo, for preventing preterm birth in unselected twin pregnancies.Design Randomised controlled double-blind multicentre trial (1:1:1).Setting The study was carried out in five university centres from Valencia, Murcia and Alicante (Spain).Population Women with dichorionic diamniotic twin pregnancies.Methods The women self-inserted two vaginal pessaries daily, containing placebo (n = 96), 200 mg of natural progesterone (n = 97) or 400 mg of natural progesterone (n = 97), from 20 to 34 weeks of gestation or delivery. Randomisation was performed by an external centre. Data were analysed on an intention-to-treat basis.Main outcome measure Preterm birth rate.Results The baseline characteristics for placebo and progesterone groups were similar. Comparison of the three groups and analysis of progesterone-treated versus untreated women showed similar pregnancy and neonatal outcomes. The proportion of preterm and very preterm births, low birthweight, perinatal mortality and neonatal morbidity showed no differences between the three groups. Similar results were also obtained when comparing the 200-versus 400-mg progesterone groups. No serious adverse effects were encountered.Conclusions Vaginal progesterone therapy was generally well tolerated, but failed to prevent preterm births in unselected dichorionic diamniotic twin pregnancies. The 400-mg progesterone dose offered no advantages over the 200-mg regimen.

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“…Subanalysen der anderen Studien zur Prävention der Frühgeburt durch die Gabe von Progesteron konnten dies bestä-tigen [40,48,49,50,51] …”

Section: Progesteron Und Mehrlingsgraviditätunclassified

Progesteron zur Prävention der Frühgeburt

Nonnenmacher

2012

Gynäkologe

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Frühgeburten sind weltweit die Hauptursache für perinatale Morbidität und Mortalität [1]. Neueren Schät-zungen zufolge waren in 2005 weltweit von allen Geburten, 12,9 Mio. (9,8%) Frühgeburten; von ihnen etwa 11 Mio. (85%) in Afrika und Asien, 500.000 jeweils in Europa und Nordamerika und 900.000 in Lateinamerika und der Karibik. Die höchste Rate an Frühgeburten haben Afrika (11,9%) und Nordamerika (10,6%), die niedrigste Europa (6,2%) [2]. Die Zahl der Frühgeburten ist in Europa in den letzten 10 Jahren in fast allen Ländern gestiegen. Im Jahr 2007 lag die Frühgeburtenrate in Deutschland bei 7,1% [3]. In den USA ist die Rate an Frühgeburten in den letzten 25 Jahren um 36% von 9,4% 1981 auf 12,8% 2006 gestiegen. Dieser Anstieg ist zum Teil auf Probleme in der Schwangerschaft, die durch die assistierte Reproduktion entstehen, zurückzuführen [4, 5].

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Vaginal micronized progesterone and risk of preterm delivery in high‐risk twin pregnancies: secondary analysis of a placebo‐controlled randomized trial and meta‐analysis

Cited by 65 publications

References 28 publications

Gestational age at cervical length measurement and preterm birth in twins

Gestational age at cervical length measurement and preterm birth in twins

Increased doses of vaginal progesterone for the prevention of preterm birth in twin pregnancies: a randomised controlled double‐blind multicentre trial

Progesteron zur Prävention der Frühgeburt

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