Clinical trial NCT02913495: Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
Official title: Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premature Birth
Keywords: Progesterone
Prevention of preterm birth
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Baystate Medical Center
name: George Washington University
name: Vriginia Commonwealth University
name: Ohio State University
First posted: 2016-09-23
Enrollment: 205
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Preterm birth is one of the leading causes of neonatal morbidity and mortality. One of the greatest predictors of preterm birth is a history of prior spontaneous preterm birth. Presently 17 hydroxyprogesterone caproate (intramuscular) is the only FDA approved product for the prevention of recurrent preterm birth, however recent studies suggest that vaginal progesterone may be used for this purpose, and may even be superior. The American College of Obstetrics and Gynecology does not specify the optimal route of progesterone administration for the prevention of recurrent preterm birth. It is our intention to compare vaginal and intramuscular progesterone to see if one is superior.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with singleton pregnancies
* ≥18 years old
* Estimated gestational age less than 24 0/7 weeks
* Prior spontaneous preterm birth of a singleton pregnancy between 16 0/7-36 6/7 weeks.
* Patients are also required provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.

Exclusion Criteria:

* History of an adverse reaction to progesterone;
* A contraindication to progesterone treatment;
* Placenta previa or accreta;
* Major fetal anomaly diagnosed on ultrasound or known chromosomal disorder;
* Multifetal gestation;
* Preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment

Primary outcomes:
measure: Preterm birth <37 weeks
timeFrame: up to 9 months (delivery)
Secondary outcomes:
measure: Gestational age of delivery
timeFrame: up to 9 months (delivery)
measure: Preterm birth <34 weeks and <28 weeks
timeFrame: up to 9 months (delivery)
measure: Second trimester cervical length <25mm
timeFrame: 2 months
measure: Mode of delivery
timeFrame: up to 9 months (delivery)
measure: Maternal mortality
timeFrame: up to 9 months (delivery)
measure: 5 minute Apgar score
timeFrame: up to 9 months (delivery)
measure: Neonatal intensive care unit admission
timeFrame: up to 9 months (delivery)
measure: Composite neonatal morbidity
timeFrame: up to 9 months (delivery)
measure: Birthweight
timeFrame: up to 9 months (delivery)
measure: Perinatal mortality up to 28 days of life
timeFrame: up to 10 months (4 weeks after delivery)
measure: Medication side effects
timeFrame: up to 9 months (delivery)
measure: Satisfaction with medication (5 point Likert scale)
timeFrame: up to 9 months (delivery)
measure: Medication adherence
timeFrame: up to 9 months (delivery)
measure: Planned subgroup analysis for the outcome preterm birth <37 weeks, <34 weeks, <28 weeks
timeFrame: up to 9 months (delivery)
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University Hospital; Sidney Kimmel Medical College
name: Rupsa C Boelig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.