N/A
N=174
Comparing IM vs. Vaginal Progesterone for Pre-term Birth
Infant, Premature · Premature Birth
Bottom Line
View on ClinicalTrials.gov: NCT00579553 ↗Enrolled (actual)
174
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Preterm Birth — 29; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intramuscular Progesterone (Drug); Vaginal Progesterone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Oklahoma
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Preterm Birth |
13; 14; 7; 8 | — |
| SECONDARY Preterm Birth |
13; 14; 7; 8 | — |
| SECONDARY Gestational Age at Delivery |
35.8; 36.3 | — |
| SECONDARY Mean Neonatal Birth Weight |
2680.6; 2771.6 | — |
Summary
This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes.
Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.
Eligibility Criteria
Inclusion Criteria
- Singleton pregnancies
- History of spontaneous preterm brith (between 20 weeks and 36 weeks 6 days)
- Gestational age between 16 weeks 0 days and 20 weeks 6 days.
- Signed consent to participate in the trial
Exclusion Criteria
- Multiple Gestation
- Prior elective fetal reduction or planned termination
- Known spontaneous reduction to singleton
- Major fetal anomaly or known fetal chromosomal abnormalities
- Progesteone used this pregnancy
Data sourced from ClinicalTrials.gov (NCT00579553). 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.