Journal article
Population differences and the effect of vaginal progesterone on preterm birth in women with threatened preterm labor (.).
- Hermans FJ a Department of Obstetrics and Gynaecology , Academic Medical Center , Amsterdam , the Netherlands .
- Karolinski A b Centro De Investigación En Salud Poblacional - CISAP - (Population Health Research Center), Hospital GA Carlos G Durand , Buenos Aires , Argentina .
- Othenin-Girard V c Department of Obstetrics and Gynaecology , Geneva University Hospitals and University of Geneva Faculty of Medicine , Geneva , Switzerland .
- Bertolino MV b Centro De Investigación En Salud Poblacional - CISAP - (Population Health Research Center), Hospital GA Carlos G Durand , Buenos Aires , Argentina .
- Schuit E a Department of Obstetrics and Gynaecology , Academic Medical Center , Amsterdam , the Netherlands .
- Salgado P b Centro De Investigación En Salud Poblacional - CISAP - (Population Health Research Center), Hospital GA Carlos G Durand , Buenos Aires , Argentina .
- Hösli I f Department of Obstetrics and Gynaecology , University Hospital, University Basel , Basel , Switzerland .
- Irion O c Department of Obstetrics and Gynaecology , Geneva University Hospitals and University of Geneva Faculty of Medicine , Geneva , Switzerland .
- Laterra C g Department of Obstetrics and Gynaecology , Hospital Materno Infantil Ramón Sardá , Buenos Aires , Argentina .
- Mol BW h The Robinson Research Institute, School of Medicine, University of Adelaide , Adelaide , Australia , and.
- Martinez de Tejada B c Department of Obstetrics and Gynaecology , Geneva University Hospitals and University of Geneva Faculty of Medicine , Geneva , Switzerland .
- 2015-11-21
Published in:
- The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians. - 2016
Harm
population differences
preterm birth
randomized controlled trial
secondary analysis
selection criteria
threatened preterm labor
treatment effect
treatment interaction
vaginal progesterone
Adult
Argentina
Chi-Square Distribution
Double-Blind Method
Female
Gestational Age
Humans
Obstetric Labor, Premature
Pregnancy
Premature Birth
Progesterone
Progestins
Proportional Hazards Models
Statistics, Nonparametric
Switzerland
Young Adult
English
OBJECTIVE
Threatened preterm labor (tPTL) is a complication of pregnancy. Identification of women and clinical definition differs between countries. This study investigated differences in tPTL and effectiveness of vaginal progesterone to prevent preterm birth (PTB) between two countries.
METHODS
Secondary analysis of a randomized controlled trial (RCT) from Argentina and Switzerland comparing vaginal progesterone to placebo in women with tPTL (n = 379). Cox proportional hazards analysis was performed to compare placebo groups of both countries and to compare progesterone to placebo within each country. We adjusted for baseline differences. Iatrogenic onset of labor or pregnancy beyond gestational age of interest was censored.
RESULTS
Swiss and Argentinian women were different on baseline. Risks for delivery <14 days and PTB < 34 and < 37 weeks were increased in Argentina compared to Switzerland, HR 3.3 (95% CI 0.62-18), 54 (95% CI 5.1-569) and 3.1 (95% CI 1.1-8.4). In Switzerland, progesterone increased the risk for delivery <14 days [HR 4.4 (95% CI 1.3-15.7)] and PTB <37 weeks [HR 2.5 (95% CI 1.4-4.8)], in Argentina there was no such effect.
CONCLUSION
In women with tPTL, the effect of progesterone may vary due to population differences. Differences in populations should be considered in multicenter RCTs.
Threatened preterm labor (tPTL) is a complication of pregnancy. Identification of women and clinical definition differs between countries. This study investigated differences in tPTL and effectiveness of vaginal progesterone to prevent preterm birth (PTB) between two countries.
METHODS
Secondary analysis of a randomized controlled trial (RCT) from Argentina and Switzerland comparing vaginal progesterone to placebo in women with tPTL (n = 379). Cox proportional hazards analysis was performed to compare placebo groups of both countries and to compare progesterone to placebo within each country. We adjusted for baseline differences. Iatrogenic onset of labor or pregnancy beyond gestational age of interest was censored.
RESULTS
Swiss and Argentinian women were different on baseline. Risks for delivery <14 days and PTB < 34 and < 37 weeks were increased in Argentina compared to Switzerland, HR 3.3 (95% CI 0.62-18), 54 (95% CI 5.1-569) and 3.1 (95% CI 1.1-8.4). In Switzerland, progesterone increased the risk for delivery <14 days [HR 4.4 (95% CI 1.3-15.7)] and PTB <37 weeks [HR 2.5 (95% CI 1.4-4.8)], in Argentina there was no such effect.
CONCLUSION
In women with tPTL, the effect of progesterone may vary due to population differences. Differences in populations should be considered in multicenter RCTs.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.3109/14767058.2015.1121476
- PMID 26586448
- Persistent URL
- https://sonar.ch/global/documents/201912
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