17-alpha-hydroxyprogesterone caproate versus vaginal progesterone suppository for the prevention of preterm birth in women with a sonographically short cervix: A randomized controlled trial

2016 ◽  
Vol 43 (1) ◽  
pp. 57-64 ◽  
Author(s):  
Reihaneh Pirjani ◽  
Reza Heidari ◽  
Abbas Rahimi-Foroushani ◽  
Seyedehsara Bayesh ◽  
Arezoo Esmailzadeh
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Birth ◽  
Controlled Trial ◽  
Short Cervix ◽  
Randomized Controlled ◽  
Vaginal Progesterone ◽  
Hydroxyprogesterone Caproate

scholarly journals A randomized controlled trial on the use of pessary plus progesterone to prevent preterm birth in women with short cervical length (P5 trial)

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Rodolfo C. Pacagnella ◽  
◽  
Ben W. Mol ◽  
Anderson Borovac-Pinheiro ◽  
Renato Passini ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Birth ◽  
Controlled Trial ◽  
Transvaginal Ultrasound ◽  
Cervical Length ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Short Cervix ◽  
Randomized Controlled ◽  
Vaginal Progesterone

Abstract Background Preterm birth is the leading cause of mortality and disability in newborn and infants. Having a short cervix increases the risk of preterm birth, which can be accessed by a transvaginal ultrasound scan during the second trimester. In women with a short cervix, vaginal progesterone and pessary can both reduce this risk, which progesterone more established than cervical pessary. The aim of this study is to compare the use of vaginal progesterone alone versus the association of progesterone plus pessary to prevent preterm birth in women with a short cervix. Methods This is a pragmatic open-label randomized controlled trial that will take place in 17 health facilities in Brazil. Pregnant women will be screened for a short cervix with a transvaginal ultrasound between 18 0/7 until 22 6/7 weeks of gestational age. Women with a cervical length below or equal to 30 mm will be randomized to the combination of progesterone (200 mg) and pessary or progesterone (200 mg) alone until 36 + 0 weeks. The primary outcome will be a composite of neonatal adverse events, to be collected at 10 weeks after birth. The analysis will be by intention to treat. The sample size is 936 women, and a prespecified subgroup analysis is planned for cervical length (= < or > 25 mm). Categorical variables will be expressed as a percentage and continuous variables as mean with standard deviation. Time to delivery will be assessed with Kaplan-Meier analysis and Cox proportional hazard analysis. Discussion In clinical practice, the combination of progesterone and pessary is common however, few studies have studied this association. The combination of treatment might act in both the biochemical and mechanical routes related to the onset of preterm birth. Trial registration Brazilian Clinical Trial Registry (ReBec) RBR-3t8prz, UTN: U1111–1164-2636, 2014/11/18.

scholarly journals Maintenance Treatment With Vaginal Progesterone or Placebo Delayed Preterm Birth More Efficiently Than Intravenous Tocolysis Alone – A Randomized Controlled Trial

2020 ◽  
Author(s):  
Ylva Vladic Stjernholm ◽  
Giovanna Marchini
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Birth ◽  
Preterm Labor ◽  
Maintenance Treatment ◽  
Reference Group ◽  
Controlled Trial ◽  
University Hospital ◽  
Pathogen Invasion ◽  
Randomized Controlled ◽  
Vaginal Progesterone

Abstract Objective To evaulate the efficacy of maintenance treatment with vaginal progesterone gel compared to placebo in women after the onset of preterm labor.Material and Methods A randomized controlled trial at a university hospital in Sweden in 2009 − 18. Healthy women with singleton pregnancy and early preterm labor were randomized to daily progesterone gel 90 mg (n = 29) or placebo (n = 29) after standard intravenous tocolysis. Women with intravenous tocolysis alone (n = 29) served as a reference group. Results The latency to delivery was 58 ± 34 days with progesterone, 64 ± 51 days with placebo and 2 ± 2 days in the reference group (p < 0.0001 respectively). The rate of preterm birth < 34 weeks was 34% after progesterone, 38% after placebo and 100% in the reference group (progesterone vs reference p = 0.01 and placebo vs reference p = 0.02). The composite neonatal morbidity and length of neonatal intensive care were lower after progesterone and placebo compared to the reference group (p < 0.0001 respectively).Conclusion Maintenance treatment with vaginal progesterone gel or placebo delayed preterm birth more efficiently than intravenous tocolysis alone, suggesting an effect of the placebo gel rather than of progesterone. We conclude, that the placebo gel reinforced the physiological barrier at the uterine cervix which protects the pregnancy from pathogen invasion and uterine infection leading to preterm birth.

scholarly journals LB 1: Randomized controlled trial: Arabin pessary to prevent preterm birth in twin pregnancies with short cervix

2020 ◽  
Vol 222 (1) ◽  
pp. S756 ◽  
Author(s):  
Jane E. Norman ◽  
John Norrie ◽  
Graeme MacLennan ◽  
David Cooper ◽  
Sonia Whyte ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Birth ◽  
Controlled Trial ◽  
Short Cervix ◽  
Randomized Controlled ◽  
Twin Pregnancies

A Randomized Controlled Trial of Intramuscular Versus Vaginal Progesterone for the Prevention of Recurrent Preterm Birth

2016 ◽  
Vol 71 (12) ◽  
pp. 689-690 ◽  
Author(s):  
Andrew Elimian ◽  
Katie Smith ◽  
Marvin Williams ◽  
Eric Knudtson ◽  
Jean R. Goodman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Birth ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Vaginal Progesterone
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