Vaginal compared with intramuscular progestogen for preventing preterm birth in high-risk pregnant women (VICTORIA study): a multicentre, open-label randomised trial and meta-analysis.
Preterm birth
prevention
progestogen
short cervical length
Journal
BJOG : an international journal of obstetrics and gynaecology
ISSN: 1471-0528
Titre abrégé: BJOG
Pays: England
ID NLM: 100935741
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
accepted:
02
06
2020
pubmed:
15
6
2020
medline:
15
12
2020
entrez:
15
6
2020
Statut:
ppublish
Résumé
To compare the efficacy of two types of progestogen therapy for preventing preterm birth (PTB) and to review the relevant literature. A multicentre, randomised, open-label, equivalence trial and a meta-analysis. Tertiary referral hospitals in South Korea. Pregnant women with a history of spontaneous PTB or short cervical length (<25 mm). Eligible women were screened and randomised at 16-22 weeks of gestation to receive either 200 mg of vaginal micronised progesterone daily (vaginal group) or an intramuscular injection of 250 mg 17α-hydroxyprogesterone caproate weekly (IM group). Stratified randomisation was carried out according to participating centres and indications for progestogen therapy. This trial was registered at ClinicalTrials.gov (NCT02304237). Preterm birth (PTB) before 37 weeks of gestation. A total of 266 women were randomly assigned and a total of 247 women (119 and 128 women in the vaginal and IM groups, respectively) were available for the intention-to-treat analysis. Risks of PTB before 37 weeks of gestation did not significantly differ between the two groups (22.7 versus 25.8%, P = 0.571). The difference in PTB risk between the two groups was 3.1% (95% CI -7.6 to 13.8%), which was within the equivalence margin of 15%. The meta-analysis results showed no significant differences in the risk of PTB between the vaginal and IM progestogen treatments. Compared with vaginal progesterone, treatment with intramuscular progestin might increase the risk of PTB before 37 weeks of gestation by as much as 13.8%, or reduce the risk by as much as 7.6%, in women with a history of spontaneous PTB or with short cervical length. Vaginal and intramuscular progestogen showed equivalent efficacy for preventing preterm birth before 37 weeks of gestation.
Identifiants
pubmed: 32536019
doi: 10.1111/1471-0528.16365
doi:
Substances chimiques
Progestins
0
Banques de données
ClinicalTrials.gov
['NCT02304237']
Types de publication
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1646-1654Subventions
Organisme : Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare
ID : HI14C0306
Pays : International
Organisme : Besins Healthcare
Pays : International
Organisme : Han Wha Pharma Co., Ltd
Pays : International
Informations de copyright
© 2020 Royal College of Obstetricians and Gynaecologists.
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