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| ID | Type | Description | Link |
|---|---|---|---|
| 17976 | Other Identifier | Stanford University Medical Center |
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Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy in a group of patients in whom this medication has not been previously studied. Specifically, we hope to learn whether progesterone supplementation will delay delivery in women with pre-term, premature rupture of membranes (PPROM).
When women present to either the Obstetrical clinic or labor and delivery with a complaint of possible preterm, premature rupture of membranes (PPROM), they will be examined by an obstetrician to either confirm or rule out this diagnosis. If they are diagnosed with PPROM, they will then be admitted to Lucile Packard Children's Hospital and treated with the normal protocol which includes receiving antibiotics, receiving steroids, being hospitalized until delivery, and having ongoing maternal and fetal monitoring for possible complications. The patients will be identified by their treating obstetricians as possible study candidates and asked by a member of the treatment team if they are potentially interested in participating in a research study. Subsequently, a member of the study team or the treating physician will approach the patient about participating in the trial. Those who choose to participate will receive the standard care protocol in addition to receiving the study medication. The study medication will be a weekly injection of either placebo or 17-hydroxyprogesterone caproate or placebo. The placebo medication (castor oil) was chosen as it has been used in previous studies as a placebo for 17-hydroxyprogesterone caproate. The choice of which medication the patient receives will be determined by a randomization table. Only the pharmacist will be aware of the medication that has been administered. The patient, members of the treatment team, and members of the study team will be blinded to the medication that is being administered. The timing of their delivery will be managed by the treating obstetrician according to standard medical practice. After delivery, the patient's and her infant's medical outcomes will be recorded for analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 17-hydroxyprogesterone caproate | Active Comparator | Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation |
|
| Castor oil injections | Placebo Comparator | Weekly injections of Caster Oil (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17-Hydroxyprogesterone Caproate | Drug | Weekly injections of 17-hydroxyprogesterone caproate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Achievement of 34 Weeks Gestation | Delayed delivery until 34 weeks gestation. | From enrollment until delivery, an average of 34 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Neonatal Respiratory Distress Syndrome | From delivery until neonatal hospital discharge, assessed up to 2 months | |
| Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage | From delivery until neonatal hospital discharge, assessed up to 2 months |
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Inclusion Criteria:
Exclusion Criteria:
Contraindication to ongoing pregnancy including:
Major fetal malformation
Maternal allergy to progesterone or placebo drug components
Current use of progesterone at the time of P-PROM
Multiple Gestations
Inability to understand consent in either English or Spanish
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| Name | Affiliation | Role |
|---|---|---|
| Yasser Y El-Sayed, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Clara Valley Medical Center | San Jose | California | 95128 | United States | ||
| Stanford University School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | 17-hydroxyprogesterone Caproate | Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation 17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate. |
| FG001 | Castor Oil Injections | Weekly injections of Caster Oil (placebo) Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 17-hydroxyprogesterone Caproate | Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation 17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate. |
| BG001 | Castor Oil Injections |
| 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 | Number of Participants With Achievement of 34 Weeks Gestation | Delayed delivery until 34 weeks gestation. | Posted | Count of Participants | Participants | From enrollment until delivery, an average of 34 weeks |
|
From enrollment up to discharge from the delivery hospital, assessed up to 2 months after 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 | 17-hydroxyprogesterone Caproate | Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation 17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anna Girsen | Stanford University | 6507255720 | agirsen@stanford.edu |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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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| Caster Oil injections | Other | Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation. |
|
|
| Number of Participants With Neonatal Necrotizing Enterocolitis | From delivery to neonatal discharge, assessed up to 2 months |
| Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days | From birth to discharge form delivery hospital, assessed up to 2 months |
| Length of Latency Assessed as Number of Days | From rupture of membranes until delivery, assessed up to 34 weeks of gestation |
| Stanford |
| California |
| 94305 |
| United States |
Weekly injections of Caster Oil (placebo) Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation. |
| 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 | Count of Participants | Participants |
|
| History of prior preterm birth | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Neonatal Respiratory Distress Syndrome | Posted | Count of Participants | Participants | From delivery until neonatal hospital discharge, assessed up to 2 months |
|
|
|
|
| Secondary | Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage | Posted | Count of Participants | Participants | From delivery until neonatal hospital discharge, assessed up to 2 months |
|
|
|
|
| Secondary | Number of Participants With Neonatal Necrotizing Enterocolitis | Posted | Count of Participants | Participants | From delivery to neonatal discharge, assessed up to 2 months |
|
|
|
|
| Secondary | Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days | Posted | Mean | 95% Confidence Interval | days | From birth to discharge form delivery hospital, assessed up to 2 months |
|
|
|
|
| Secondary | Length of Latency Assessed as Number of Days | Posted | Median | 95% Confidence Interval | days | From rupture of membranes until delivery, assessed up to 34 weeks of gestation |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Castor Oil Injections | Weekly injections of Caster Oil (placebo) Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation. | 0 | 11 | 0 | 11 | 0 | 11 |
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| 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 |