17-OHPC to Prevent Recurrent Preterm Birth in Singleton Gestations (PROLONG Study): A Multicenter, International, Randomized Double-Blind Trial.
17 alpha-Hydroxyprogesterone Caproate
/ adverse effects
Double-Blind Method
Female
Gestational Age
Humans
Infant, Newborn
Infant, Newborn, Diseases
/ epidemiology
Injections, Intramuscular
Perinatal Death
Pregnancy
Pregnancy Complications
/ epidemiology
Pregnancy Outcome
Premature Birth
/ prevention & control
Progestins
/ adverse effects
Secondary Prevention
Treatment Failure
Journal
American journal of perinatology
ISSN: 1098-8785
Titre abrégé: Am J Perinatol
Pays: United States
ID NLM: 8405212
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
pubmed:
28
10
2019
medline:
29
7
2020
entrez:
26
10
2019
Statut:
ppublish
Résumé
Women with a history of spontaneous preterm birth (SPTB) are at a significantly increased risk for recurrent preterm birth (PTB). To date, only one large U.S. clinical trial comparing 17-OHPC (17-α-hydroxyprogesterone caproate or "17P") to placebo has been published, and this trial was stopped early due to a large treatment benefit. This study aimed to assess whether 17-OHPC decreases recurrent PTB and neonatal morbidity in women with a prior SPTB in a singleton gestation. This was a double-blind, placebo-controlled international trial involving women with a previous singleton SPTB ( Baseline characteristics between the 1,130 women who received 17-OHPC and 578 women who received placebo were similar. Overall, 87% of enrolled women were Caucasian, 12% had >1 prior SPTB, 7% smoked cigarettes, and 89% were married/lived with partner. Prior to receiving study drug, 73% women had a transvaginal cervical length measurement performed and <2% had cervical shortening <25 mm. There were no significant differences in the frequency of PTB < 35 weeks (17-OHPC 11.0% vs. placebo 11.5%; relative risk = 0.95 [95% confidence interval (CI): 0.71-1.26]) or neonatal morbidity index (17-OHPC 5.6% vs. placebo 5.0%; relative risk = 1.12 [95% CI: 0.68-1.61]). There were also no differences in frequency of fetal/early infant death (17-OHPC 1.7% vs. placebo 1.9%; relative risk = 0.87 [95% CI: 0.4-1.81]. Maternal outcomes were also similar. In the subgroup of women enrolled in the United States ( In this study population, 17-OHPC did not decrease recurrent PTB and was not associated with increased fetal/early infant death.
Sections du résumé
BACKGROUND
Women with a history of spontaneous preterm birth (SPTB) are at a significantly increased risk for recurrent preterm birth (PTB). To date, only one large U.S. clinical trial comparing 17-OHPC (17-α-hydroxyprogesterone caproate or "17P") to placebo has been published, and this trial was stopped early due to a large treatment benefit.
OBJECTIVE
This study aimed to assess whether 17-OHPC decreases recurrent PTB and neonatal morbidity in women with a prior SPTB in a singleton gestation.
STUDY DESIGN
This was a double-blind, placebo-controlled international trial involving women with a previous singleton SPTB (
RESULTS
Baseline characteristics between the 1,130 women who received 17-OHPC and 578 women who received placebo were similar. Overall, 87% of enrolled women were Caucasian, 12% had >1 prior SPTB, 7% smoked cigarettes, and 89% were married/lived with partner. Prior to receiving study drug, 73% women had a transvaginal cervical length measurement performed and <2% had cervical shortening <25 mm. There were no significant differences in the frequency of PTB < 35 weeks (17-OHPC 11.0% vs. placebo 11.5%; relative risk = 0.95 [95% confidence interval (CI): 0.71-1.26]) or neonatal morbidity index (17-OHPC 5.6% vs. placebo 5.0%; relative risk = 1.12 [95% CI: 0.68-1.61]). There were also no differences in frequency of fetal/early infant death (17-OHPC 1.7% vs. placebo 1.9%; relative risk = 0.87 [95% CI: 0.4-1.81]. Maternal outcomes were also similar. In the subgroup of women enrolled in the United States (
CONCLUSION
In this study population, 17-OHPC did not decrease recurrent PTB and was not associated with increased fetal/early infant death.
Identifiants
pubmed: 31652479
doi: 10.1055/s-0039-3400227
doi:
Substances chimiques
Progestins
0
17 alpha-Hydroxyprogesterone Caproate
276F2O42F5
Banques de données
ClinicalTrials.gov
['NCT01004029']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
127-136Informations de copyright
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
Déclaration de conflit d'intérêts
P.N., J.B., O.M.Y., G.I.R., N.Y.R., O.P., N.T. are PROLONG clinical site investigators.C.G.-B. and J.R.B. have received grant funding for other project(s) from the sponsor (AMAG Pharmaceuticals, Inc.).G.R.S. and H.S.M. have received consulting fees from AMAG Pharmaceuticals, Inc.A.F.D. has received consulting/personal fees related to her work on the project from the sponsor (AMAG Pharmaceuticals, Inc.).J.G., R.B., M.J.J., M.D., L.W., J.K. are current or former employees of AMAG Pharmaceuticals, Inc.