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| Name | Class |
|---|---|
| Baystate Medical Center | OTHER |
| George Washington University | OTHER |
| Vriginia Commonwealth University | UNKNOWN |
| Ohio State University |
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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.
Preterm birth is one of the leading causes of neonatal morbidity and mortality. One of the greatest predictors of preterm birth is a history of prior spontaneous preterm birth. Presently 17 hydroxyprogesterone caproate (intramuscular) is the only FDA approved product for the prevention of recurrent preterm birth, however recent studies suggest that vaginal progesterone may be used for this purpose, and may even be superior. The American College of Obstetrics and Gynecology does not specify the optimal route of progesterone administration for the prevention of recurrent preterm birth. It is our intention to compare vaginal and intramuscular progesterone to see if one is superior.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Progesterone | Drug |
|
| |
| Intramuscular Progesterone (17 alpha hydroxprogesterone caproate) |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm Birth <37 Weeks | Incidence of gestational age of delivery less than 37 weeks | up to 9 months (delivery) |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational Age of Delivery | Gestational age at delivery (weeks) | up to 9 months (delivery) |
| Preterm Birth <34 Weeks | Delivery of pregnancy 20 0/7 - 33 6/7 weeks gestation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rupsa C Boelig, MD | Thomas Jefferson University Hospital; Sidney Kimmel Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Washington D.C. | District of Columbia | United States | |||
| Baystate Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22996126 | Background | 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. | |
| 27546354 | 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. |
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Results will be available, individual participant data may not be
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5 excluded (N=2 miscarriage, N=3 withdrawal) prior to randomization
Enrollment 2016 - 2021
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaginal Progesterone | 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 Vaginal Progesterone |
| FG001 | Intramuscular Progesterone | 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. Intramuscular Progesterone (17 alpha hydroxprogesterone caproate) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaginal Progesterone | 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 Vaginal Progesterone |
| BG001 | Intramuscular Progesterone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Preterm Birth <37 Weeks | Incidence of gestational age of delivery less than 37 weeks | Posted | Count of Participants | Participants | up to 9 months (delivery) |
|
Until delivery
Serious adverse event was defined as an event likely related to medication assignment resulting in hospitalization, need for additional therapies to manage AE, or mortality
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaginal Progesterone | 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 Vaginal Progesterone |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Early cessation | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rupsa C. Boelig | Thomas Jefferson University | 215-955-9196 | rupsa.boelig@jefferson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2019 | Jun 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| D000077713 | 17 alpha-Hydroxyprogesterone Caproate |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| OTHER |
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| Drug |
|
|
| up to 9 months (delivery) |
| Second Trimester Cervical Length <25mm | Short cervix diagnosis (transvaginal ultrasound cervical length <=25mm prior to 24 weeks gestation | 2 months |
| Mode of Delivery: Cesarean Section | Delivery mode- vaginal, cesarean, operative vaginal | up to 9 months (delivery) |
| Maternal Mortality | Maternal death for any reason from enrollment through hospital discharge from delivery hospitalization. | up to 9 months (delivery) |
| 5 Minute Apgar Score<7 | The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. | up to 9 months (delivery) |
| Neonatal Intensive Care Unit Admission | Admission to neonatal intensive care unit for any reason (yes/no) | up to 9 months (delivery) |
| Composite Neonatal Morbidity | Having at least one of the following: respiratory distress syndrome, grade III or IV intraventricular hemorrhage, culture proven sepsis, neonatal enterocolitis, or perinatal mortality up to 28 days of life | up to 9 months (delivery) |
| Birthweight | Birthweight assessed at delivery (grams) | up to 9 months (delivery) |
| Perinatal Mortality up to 28 Days of Life | In utero or neonatal death from enrollment through 28 days of neonatal life. | up to 10 months (4 weeks after delivery) |
| Medication Side Effects | Medication side effects | up to 9 months (delivery) |
| Satisfaction With Medication (5 Point Likert Scale) | 5 point scale, 0 is very dissatisfied, 5 is very satisfied, 3 is neutral | up to 9 months (delivery) |
| Medication Adherence | Vaginal progesterone:
Intramuscular progesterone:
| up to 9 months (delivery) |
| Planned Subgroup Analysis for the Outcome Preterm Birth <37 Weeks, <34 Weeks, <28 Weeks | Planned subgroup analysis for the primary outcome of patients with a cervical length <25mm versus ≥25mm, history-indicated cerclage versus not, and for those started on progesterone 16-20 weeks versus 20-24 weeks. | up to 9 months (delivery) |
| Springfield |
| Massachusetts |
| 01199 |
| United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| 35189093 | Derived | 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. |
| Pregnancy termination |
|
| Miscarriage<16wk |
|
| Placenta previa |
|
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. Intramuscular Progesterone (17 alpha hydroxprogesterone caproate) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Gestational Age of Delivery | Gestational age at delivery (weeks) | Posted | Mean | Standard Deviation | weeks | up to 9 months (delivery) |
|
|
|
| Secondary | Preterm Birth <34 Weeks | Delivery of pregnancy 20 0/7 - 33 6/7 weeks gestation | Posted | Count of Participants | Participants | up to 9 months (delivery) |
|
|
|
| Secondary | Second Trimester Cervical Length <25mm | Short cervix diagnosis (transvaginal ultrasound cervical length <=25mm prior to 24 weeks gestation | Posted | Count of Participants | Participants | 2 months |
|
|
|
| Secondary | Mode of Delivery: Cesarean Section | Delivery mode- vaginal, cesarean, operative vaginal | Posted | Count of Participants | Participants | up to 9 months (delivery) |
|
|
|
| Secondary | Maternal Mortality | Maternal death for any reason from enrollment through hospital discharge from delivery hospitalization. | Posted | Count of Participants | Participants | up to 9 months (delivery) |
|
|
|
| Secondary | 5 Minute Apgar Score<7 | The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. | Posted | Count of Participants | Participants | up to 9 months (delivery) |
|
|
|
| Secondary | Neonatal Intensive Care Unit Admission | Admission to neonatal intensive care unit for any reason (yes/no) | Posted | Count of Participants | Participants | up to 9 months (delivery) |
|
|
|
| Secondary | Composite Neonatal Morbidity | Having at least one of the following: respiratory distress syndrome, grade III or IV intraventricular hemorrhage, culture proven sepsis, neonatal enterocolitis, or perinatal mortality up to 28 days of life | Population analyzed limited to those with neonatal outcome data available regarding presence or absence of the composite findings. | Posted | Count of Participants | Participants | up to 9 months (delivery) |
|
|
|
| Secondary | Birthweight | Birthweight assessed at delivery (grams) | Population analyzed limited to those with neonatal outcome data available. | Posted | Mean | Standard Deviation | grams | up to 9 months (delivery) |
|
|
|
| Secondary | Perinatal Mortality up to 28 Days of Life | In utero or neonatal death from enrollment through 28 days of neonatal life. | Posted | Count of Participants | Participants | up to 10 months (4 weeks after delivery) |
|
|
|
| Secondary | Medication Side Effects | Medication side effects | Posted | Count of Participants | Participants | up to 9 months (delivery) |
|
|
|
| Secondary | Satisfaction With Medication (5 Point Likert Scale) | 5 point scale, 0 is very dissatisfied, 5 is very satisfied, 3 is neutral | Participants analyzed limited to those who completed survey | Posted | Mean | Standard Deviation | units on a scale 1-5 | up to 9 months (delivery) |
|
|
|
| Secondary | Medication Adherence | Vaginal progesterone:
Intramuscular progesterone:
| Posted | Mean | Standard Deviation | percentage of doses taken | up to 9 months (delivery) |
|
|
|
| Secondary | Planned Subgroup Analysis for the Outcome Preterm Birth <37 Weeks, <34 Weeks, <28 Weeks | Planned subgroup analysis for the primary outcome of patients with a cervical length <25mm versus ≥25mm, history-indicated cerclage versus not, and for those started on progesterone 16-20 weeks versus 20-24 weeks. | Cerclage subgroup | Posted | Count of Participants | Participants | up to 9 months (delivery) |
|
|
|
| 0 |
| 94 |
| 0 |
| 94 |
| 24 |
| 94 |
| EG001 | Intramuscular Progesterone | 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. Intramuscular Progesterone (17 alpha hydroxprogesterone caproate) | 0 | 94 | 0 | 94 | 27 | 94 |
| Medication cross over | Product Issues | Systematic Assessment | Cross over to other arm |
|
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| D000091642 | Urogenital Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D019326 | 17-alpha-Hydroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| Sepsis |
|
| NEC |
|
| Perinatal mortality |
|
| None of the above |
|
| Other |
|