Phase 4
N=205
Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
Premature Birth
Bottom Line
View on ClinicalTrials.gov: NCT02913495 ↗Enrolled (actual)
205
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Preterm Birth <37 Weeks — 29; 36 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vaginal Progesterone (Drug); Intramuscular Progesterone (17 alpha hydroxprogesterone caproate) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Thomas Jefferson University
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Preterm Birth <37 Weeks |
29; 36 | — |
| SECONDARY Gestational Age of Delivery |
37.36; 36.34 | — |
| SECONDARY Preterm Birth <34 Weeks |
9; 14 | — |
| SECONDARY Second Trimester Cervical Length <25mm |
17; 14 | — |
| SECONDARY Mode of Delivery: Cesarean Section |
20; 29 | — |
| SECONDARY Maternal Mortality |
0; 0 | — |
| SECONDARY 5 Minute Apgar Score<7 |
1; 4 | — |
| SECONDARY Neonatal Intensive Care Unit Admission |
31; 25 | — |
| SECONDARY Composite Neonatal Morbidity |
8; 8; 0; 0; 0; 0 | — |
| SECONDARY Birthweight |
2940; 2793 | — |
| SECONDARY Perinatal Mortality up to 28 Days of Life |
0; 3 | — |
| SECONDARY Medication Side Effects |
5; 3; 56; 42; 30; 36 | — |
| SECONDARY Satisfaction With Medication (5 Point Likert Scale) |
3.77; 4.06 | — |
| SECONDARY Medication Adherence |
82; 78 | — |
| SECONDARY Planned Subgroup Analysis for the Outcome Preterm Birth <37 Weeks, <34 Weeks, <28 Weeks |
8; 11 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02913495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.