Cervical pessary
            vs
            vaginal progesterone for prevention of preterm birth in women with twin pregnancy and short cervix: economic analysis following randomized controlled trial

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.

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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

Journal of Obstetrics and Gynaecology Research ◽

10.1111/jog.13151 ◽

2016 ◽

Vol 43 (1) ◽

pp. 57-64 ◽

Cited By ~ 5

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

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Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins)

American Journal of Obstetrics and Gynecology ◽

10.1016/j.ajog.2015.11.012 ◽

2016 ◽

Vol 214 (2) ◽

pp. 145-152 ◽

Cited By ~ 70

Author(s):

Maria Goya ◽

Maria de la Calle ◽

Laia Pratcorona ◽

Carme Merced ◽

Carlota Rodó ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Preterm Birth ◽

Controlled Trial ◽

Short Cervix ◽

Randomized Controlled ◽

Cervical Pessary ◽

Multicenter Randomized Controlled Trial

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17 alpha-hydroxyprogesterone caproate does not prolong pregnancy or reduce the rate of preterm birth in women at high risk for preterm delivery and a short cervix: a randomized controlled trial

American Journal of Obstetrics and Gynecology ◽

10.1016/j.ajog.2014.10.1097 ◽

2015 ◽

Vol 212 (4) ◽

pp. 485.e1-485.e10 ◽

Cited By ~ 31

Author(s):

Norbert Winer ◽

Florence Bretelle ◽

Marie-Victoire Senat ◽

Caroline Bohec ◽

Philippe Deruelle ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Preterm Birth ◽

High Risk ◽

Preterm Delivery ◽

Controlled Trial ◽

Short Cervix ◽

Randomized Controlled ◽

Hydroxyprogesterone Caproate

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

10.21203/rs.3.rs-87137/v1 ◽

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.

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A randomized controlled trial of two-doses of vaginal progesterone 400 vs. 200 mg for prevention of preterm labor in twin gestations

Journal of Perinatal Medicine ◽

10.1515/jpm-2021-0131 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Ahmed S. Abdel Wahab ◽

Mostafa I. Abdelmonaem ◽

Walaa M. Mahmoud ◽

Ahmed E. Mansour

Keyword(s):

Randomized Controlled Trial ◽

Preterm Labor ◽

Twin Pregnancy ◽

Controlled Trial ◽

Transvaginal Ultrasound ◽

Statistical Significance ◽

Average Weight ◽

Randomized Controlled ◽

Vaginal Progesterone ◽

Second Twin

Abstract Objectives To compare between the effectiveness and safety of two different daily doses of vaginal progesterone (400 vs. 200 mg) in the prevention of preterm labor in twin pregnancy. Methods This is a prospective single-blinded randomized controlled trial conducted on 100 primi-gravida who had twin pregnancy and attended the antenatal clinic of a University hospital. They were equally and randomly allocated into two arms each containing 50 patients. Arm 1 received 400 mg and arm 2 received 200 mg vaginal progesterone daily at bed time starting from 14 weeks of pregnancy to 36 weeks. Transvaginal ultrasound was performed for assessment of the length of cervix at 14 and 22 weeks. Results Both arms of the current study were comparable regarding the cervical length at 14 and 22 weeks, mean gestational age at delivery, incidence of pre-term delivery, birth weight of the first twin. Second twin in addition to the average weight of both twins. No statistical significance differences between two arms regarding incidence of early neonatal death. NICU, mechanical ventilation, length of admission in NICU for the first twin. Second twin as well as both twins. Conclusions Vaginal progesterone treatment with different doses was tolerable, but wasn’t effective in the prevention of preterm labor in twin pregnancy.

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