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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.
This study is intended as a randomized controlled trial. Women with singleton pregnancies between 16 and 20 weeks 6 day will be randomized to one of two treatment groups.
Those randomized to weekly intramuscular progesterone will receive 250 mg of 17 alpha hydroxyprogesterone caproate every week in the clinic between randomization and delivery for those delivery preterm or 36 weeks 6 days.
While those randomized to vaginal progesterone will receive 100 mg vaginal progesterone daily at home. Vaginal progesterone to last between clinic visits will be provided to subject. Those women in the vaginal progesterone group will also be informed on how to obtain additional medication in case of missed clinic appointment. Treatment will be continued until 36 weeks 6 days or as dictated by date of preterm delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intramuscular Progesterone | Active Comparator | Intramuscular Progesterone |
|
| Vaginal Progesterone | Experimental | Vaginal Progesterone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramuscular Progesterone | Drug | Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preterm Birth | Delivery before 37 weeks gestation. | From 16-20 weeks gestation through preterm delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm Birth | Delivery below 34 weeks gestation | From 16-20 weeks gestation through preterm delivery |
| Gestational Age at Delivery | Mean gestational age at delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Elimian, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27168167 | Derived | Elimian A, Smith K, Williams M, Knudtson E, Goodman JR, Escobedo MB. A randomized controlled trial of intramuscular versus vaginal progesterone for the prevention of recurrent preterm birth. Int J Gynaecol Obstet. 2016 Aug;134(2):169-72. doi: 10.1016/j.ijgo.2016.01.010. Epub 2016 Apr 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intramuscular Progesterone | Intramuscular Progesterone Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P |
| FG001 | Vaginal Progesterone | Vaginal Progesterone Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intramuscular Progesterone | Intramuscular Progesterone Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P |
| BG001 | Vaginal 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 | Delivery before 37 weeks gestation. | Posted | Count of Participants | Participants | From 16-20 weeks gestation through preterm delivery |
|
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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 | Intramuscular Progesterone | Intramuscular Progesterone Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Elimian, MD | University of Oklahoma Health Science Center | 19146465194 | aelimian@aol.com |
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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 |
|---|---|
| D000077713 | 17 alpha-Hydroxyprogesterone Caproate |
| ID | Term |
|---|---|
| D019326 | 17-alpha-Hydroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
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|
| Vaginal Progesterone | Drug | Vaginal Progesterone: 100 mg vaginal suppository daily |
|
| From 16-20 weeks gestation through preterm delivery |
| Mean Neonatal Birth Weight | At delivery |
Vaginal Progesterone
Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Educational Level | Count of Participants | Participants |
|
| Tobacco use | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Preterm Birth | Delivery below 34 weeks gestation | Posted | Count of Participants | Participants | From 16-20 weeks gestation through preterm delivery |
|
|
|
| Secondary | Gestational Age at Delivery | Mean gestational age at delivery | Posted | Mean | Standard Deviation | Weeks gestation | From 16-20 weeks gestation through preterm delivery |
|
|
|
| Secondary | Mean Neonatal Birth Weight | Posted | Mean | Standard Deviation | grams | At delivery |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | Vaginal Progesterone | Vaginal Progesterone Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily | 0 | 79 | 0 | 79 | 0 | 79 |
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| D000091642 | Urogenital Diseases |
| D011283 |
| Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |