ArticleTrials2020
Early universal use of oral progesterone for prevention of preterm births in singleton pregnancy (SINPRO study): protocol of a multicenter, randomized, double-blind, placebo-controlled trial.
Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03428685 (A Double Blinded Randomized Controlled Trial of Early Use of Oral Progesterone in All Women for Prevention of Preterm Delivery in Singleton Pregnancy), which is not on this map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double Blinded Randomized Controlled Trial of Early Use of Oral Progesterone in All Women for Prevention of Preterm Delivery in Singleton Pregnancy (SINPRO Study)
Who cites it
4 citing papers in PubMed, 9 citations in OpenAlex.
- Challenges in Using Progestin to Prevent Singleton Preterm Births: Current Knowledge and Clinical Advice.International journal of women's health · 2024Review
- Ameliorating adverse perinatal outcomes with Lactoferrin: An intriguing chemotherapeutic intervention.Bioorganic & medicinal chemistry · 2022Review
- Next generation strategies for preventing preterm birth.Advanced drug delivery reviews · 2021Review
- The Role of Danger Associated Molecular Patterns in Human Fetal Membrane Weakening.Frontiers in physiology · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 2 countries.
Funding
Abstract
backgroundPreterm birth accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities. For a singleton pregnancy, progesterone treatment is effective in prevention of preterm birth in women with an asymptomatic short cervix or a history of preterm birth. However, a large proportion of preterm births still is not currently preventable. The aim of this study is to determine whether early universal use of oral progesterone before 14 + 0 weeks of gestation can prevent preterm birth better than universal screening of cervical length at 18 + 0 to 23 + 6 weeks of gestation, followed by progesterone treatment in those with a short cervix in singleton pregnancy.
methodsThis is a multicenter, randomized, double-blind, placebo-controlled trial registered with ClinicalTrials.gov on 12 February 2018. Eligible consecutive pregnant women with singleton gestation attending antenatal outpatient clinics will be recruited after receiving counseling and signing the written consent form. Transvaginal cervical length measurement will be performed at recruitment (before 14 + 0 weeks of gestation) and between 18 + 0 and 23 + 6 weeks of gestation. After randomization, women will be randomly assigned to either the treatment group (oral dydrogesterone 10 mg three times daily) or the placebo group, and medication will be started before 14 + 0 weeks of gestation. Assigned groups will be unblinded if the cervical length is ≤ 25 mm between 18 + 0 and 23 + 6 weeks of gestation, and the management option for short cervix will be discussed (oral progesterone, vaginal progesterone, or cervical cerclage). The primary outcome is preterm birth before 37 + 0 weeks of gestation. DISCUSSION: Progesterone is used extensively in part of the in vitro fertilization program as luteal phase support, and it is not associated with teratogenicity. Universal progesterone supplementation may be a better approach to prevent preterm birth. This large, multicenter, randomized, double-blind, placebo-controlled trial will provide the best evidence, leading to the best strategy for the prevention of preterm birth.
trial registrationClinicalTrials.gov, NCT03428685. Registered on 12 February 2018.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.