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.
BJOG
; 127(13): 1646-1654, 2020 12.
Article
em En
| MEDLINE
| ID: mdl-32536019
ABSTRACT
OBJECTIVE:
To compare the efficacy of two types of progestogen therapy for preventing preterm birth (PTB) and to review the relevant literature.DESIGN:
A multicentre, randomised, open-label, equivalence trial and a meta-analysis.SETTING:
Tertiary referral hospitals in South Korea. POPULATION Pregnant women with a history of spontaneous PTB or short cervical length (<25 mm).METHODS:
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). MAIN OUTCOMEMEASURE:
Preterm birth (PTB) before 37 weeks of gestation.RESULTS:
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.CONCLUSION:
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. TWEETABLE ABSTRACT Vaginal and intramuscular progestogen showed equivalent efficacy for preventing preterm birth before 37 weeks of gestation.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Progestinas
/
Nascimento Prematuro
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
/
Systematic_reviews
Limite:
Adult
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Female
/
Humans
/
Pregnancy
Idioma:
En
Revista:
BJOG
Assunto da revista:
GINECOLOGIA
/
OBSTETRICIA
Ano de publicação:
2020
Tipo de documento:
Article