Pregnancy
Conditions
Keywords
Pregnancy,, prevention of preterm birth,, prevention of preterm labor,
Brief summary
This research study is being conducted at over 12 pregnancy research centers in the US. The study will compare an investigational treatment with a placebo (a treatment without medication). Neither the investigators nor the patients in the trial will know which treatment has been assigned. All study medications will be given vaginally once a day. Treatment will begin before pregnancy week 23 and will continue until the end of pregnancy week 36.
Detailed description
Patients who participate are to have: * A single baby pregnancy (no twins or triplets allowed) * Patients will start treatment before pregnancy week 23 * Patients must have a previous preterm birth (a preemie) * Patients must be 18-45 years of age
Interventions
DRUG8% progesterone vaginal gel
Progesterone 8% Vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
Placebo vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
Sponsors
Juniper Pharmaceuticals, Inc.
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
Yes
Inclusion criteria
1. The subject has a history of a documented spontaneous singleton preterm delivery (hospital or clinic record, letter from healthcare provider, or birth certificate) from 20 0/7 to 35 0/7 weeks gestational age with the immediate preceding pregnancy or has a cervical length of 2.5 cm or less measured by transvaginal ultrasound with the current pregnancy. Spontaneous preterm delivery is a delivery (\<35 weeks), either vaginal or cesarean, that is initiated by either preterm PROM followed by contractions or preterm labor initiated with in-tact membranes. A previous preterm delivery secondary to an incompetent cervix where a cerclage is considered for this pregnancy is not considered a preterm delivery (please see
Exclusion criteria
No. 10). Subjects enrolled based on a history of preterm delivery may have had a pregnancy loss (or losses) at \<20 0/7 weeks gestational age between the preceding preterm delivery and the current pregnancy. 2. The female subject is between 18 and 45 years of age at the time of screening. 3. The pregnancy has an estimated gestational age between 16 0/7 weeks and 22 6/7 weeks. 4. The subject speaks either English or a common local language. 5. The subject has voluntarily signed the Informed Consent Form and associated forms after having the contents explained, and all her questions are answered to her satisfaction and understanding. 6. In the opinion of the investigator, the subject is able to understand the study and is able to give informed consent, as well as participate in it and adhere to study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of delivery <=32 weeks | 18 weeks gestation through delivery |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of delivery preterm | 18 weeks gestation through delivery |
| Response to tocolytic therapy | Onset of preterm labor through resolution or delivery |
| Number of infant hospital days from delivery to discharge | Delivery date through hospital discharge date of infant |
Countries
United States
Outcome results
None listed