drugset / Trial / NCT02913495
Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
Phase 4
Completed
210 enrolled
Thomas Jefferson University
Baystate Medical Center · collabGeorge Washington University · collabOhio State University · collabVriginia Commonwealth University · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to evaluate the two suggested therapies for prevention of recurrent preterm birth (PTB) in women with a prior spontaneous preterm birth, vaginal and intramuscular progesterone to determine whether vaginal progesterone is superior to intramuscular progesterone in the prevention of recurrent preterm birth.
Timeline
- Start
- 2016-09
- Primary completion
- 2021-08
- Completion
- 2021-09
Outcome
Missed primary endpoint
paper There was no significant difference in preterm birth at <37 (31% vs 38%; P=.28; relative risk, 0.81 [95% confidence interval, 0.54-1.20]) PMID 35189093 ↗
paper Vaginal progesterone did not reduce the risk of recurrent preterm birth by 50% compared with 17-OHPC PMID 35189093 ↗
Publications
- Background Committee on Practice Bulletins-Obstetrics, The American College of Obstetricians and Gynecologists. Practice bulletin no. 130: prediction and prevention of preterm birth. Obstet Gynecol. 2012 Oct;120(4):964-73. doi: 10.1097/AOG.0b013e3182723b1b. No abstract available.
- Background Saccone G, Khalifeh A, Elimian A, Bahrami E, Chaman-Ara K, Bahrami MA, Berghella V. Vaginal progesterone vs intramuscular 17alpha-hydroxyprogesterone caproate for prevention of recurrent spontaneous preterm birth in singleton gestations: systematic review and meta-analysis of randomized controlled trials. Ultrasound Obstet Gynecol. 2017 Mar;49(3):315-321. doi: 10.1002/uog.17245. Epub 2017 Feb 6.
- Boelig RC, Schoen CN, Frey H, Gimovsky AC, Springel E, Backley S, Berghella V. Vaginal progesterone vs intramuscular 17-hydroxyprogesterone caproate for prevention of recurrent preterm birth: a randomized controlled trial. Am J Obstet Gynecol. 2022 May;226(5):722.e1-722.e12. doi: 10.1016/j.ajog.2022.02.012. Epub 2022 Feb 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 17-hydroxyprogesterone caproate | Unknown | 250 mg | Intramuscular |
| Subject | Progesterone | Other / unclassified | 200 mg | Other |
Indications
No indication recorded.