Preterm Birth
Conditions
Keywords
Preterm birth, prevention, progesterone, oral
Brief summary
To evaluate whether daily oral micronized progesterone is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.
Detailed description
To evaluate whether 400 mg daily oral micronized progesterone from 16 to 34 weeks' is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.
Interventions
oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks
DRUGIdentical Placebo tablet
Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks
Sponsors
Fetal Medicine Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* pregnant women less than 20 weeks' gestation who had at least one prior spontaneous preterm birth of a liveborn baby between 20 & 0/7 weeks' and 36 & 6/7 weeks' gestation.
Exclusion criteria
* multiple gestations, the presence of major fetal anomalies, progesterone use in the current pregnancy (ongoing or past), the presence of a cervical cerclage, and the presence of a placenta previa.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Recurrent Preterm Birth | Prior to 37 weeks' gestation | Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcomes | Mean +/- Std Dev gestational age of 25.9/-2.4 weeks in Progesterone group, and 28.4 +/-4.7 weeks in placebo group | Serum progesterone levels |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Progesterone Group 400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery | 20 |
| Placebo Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery | 16 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 2 |
Baseline characteristics
| Characteristic | Placebo | Progesterone Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 20 Participants | 36 Participants |
| Age, Continuous | 27.2 years STANDARD_DEVIATION 4.9 | 29.3 years STANDARD_DEVIATION 4.7 | 28 years STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 16 participants | 20 participants | 36 participants |
| Sex: Female, Male Female | 16 Participants | 20 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 16 |
| serious Total, serious adverse events | 0 / 20 | 0 / 16 |
Outcome results
Primary
Rate of Recurrent Preterm Birth
Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.
Time frame: Prior to 37 weeks' gestation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Progesterone Group | Rate of Recurrent Preterm Birth | 5 participants |
| Placebo | Rate of Recurrent Preterm Birth | 8 participants |
Secondary
Secondary Outcomes
Serum progesterone levels
Time frame: Mean +/- Std Dev gestational age of 25.9/-2.4 weeks in Progesterone group, and 28.4 +/-4.7 weeks in placebo group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progesterone Group | Secondary Outcomes | 122.6 pg/mL | Standard Deviation 61.8 |
| Placebo | Secondary Outcomes | 90.1 pg/mL | Standard Deviation 38.7 |