Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

NCT02913495 | Completed Phase 4 Results DMC

• 1 other identifier: 16D.542
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 3

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.

Conditions

Premature Birth

Keywords

Progesterone; Prevention of preterm birth

Outcome Measures

Primary Outcomes (1)

• Preterm Birth <37 Weeks

  Incidence of gestational age of delivery less than 37 weeks

  up to 9 months (delivery)

Secondary Outcomes (14)

• Gestational Age of Delivery

  up to 9 months (delivery)

• Preterm Birth <34 Weeks

  up to 9 months (delivery)

• Second Trimester Cervical Length <25mm

  2 months

• Mode of Delivery: Cesarean Section

  up to 9 months (delivery)

• Maternal Mortality

  up to 9 months (delivery)

Study Arms (2)

Vaginal Progesterone

EXPERIMENTAL

200mg micronized progesterone vaginally, to be taken daily starting at 16 0/7 - 23 6/7 weeks, and continued daily until 36 6/7 weeks' gestation or delivery

Drug: Vaginal Progesterone

Intramuscular Progesterone

ACTIVE COMPARATOR

250mg intramuscular progesterone to be administered weekly starting at 16 0/7 - 23 6/7 weeks, and continued weekly until 36 6/7 weeks' or delivery.

Drug: Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)

Interventions

Vaginal Progesterone DRUG

Also known as: micronized progesterone

Vaginal Progesterone

Intramuscular Progesterone (17 alpha hydroxprogesterone caproate) DRUG

Also known as: Makena

Intramuscular Progesterone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Baystate Medical Center: collaborator
• George Washington University: collaborator
• Vriginia Commonwealth University: collaborator
• Ohio State University: collaborator

Study Sites (3)

George Washington University

Washington D.C., District of Columbia, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (3)

• 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.

  PMID: 22996126 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.

  PMID: 27546354 BACKGROUND

• 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.

  PMID: 35189093 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone; 17 alpha-Hydroxyprogesterone Caproate

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; 17-alpha-Hydroxyprogesterone; Hydroxyprogesterones

Results Point of Contact

• Title: Rupsa C. Boelig
• Organization: Thomas Jefferson University

rupsa.boelig@jefferson.edu

215-955-9196

Study Officials

• Rupsa C Boelig, MD

  Thomas Jefferson University Hospital; Sidney Kimmel Medical College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 23, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 24, 2026
• Results First Posted: February 24, 2026

Record last verified: 2026-02

Locations

US (3)