A Phase 1/2 interventional study of 17-Hydroxyprogesterone Caproate and Caster Oil injections in Pregnancy Complications, sponsored by Stanford University. Completed at 2 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2019-04-09.
Sponsored by Stanford University · Phase 1/2, Interventional, and Treatment
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.
437 studies on the registry are indexed under Pregnancy Complications; 119 are open to participants now.
This study's enrollment of 21 is below the median of 147 across 220 interventional studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Contraindication to ongoing pregnancy including:
Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation
Drug: 17-Hydroxyprogesterone Caproate
Weekly injections of Caster Oil (placebo)
Other: Caster Oil injections
Weekly injections of 17-hydroxyprogesterone caproate.
Also known as: Active study drug
Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.
Also known as: Placebo
Number of Participants With Achievement of 34 Weeks Gestation
Delayed delivery until 34 weeks gestation.
Time frame: From enrollment until delivery, an average of 34 weeks
Number of Participants With Neonatal Respiratory Distress Syndrome
Time frame: From delivery until neonatal hospital discharge, assessed up to 2 months
Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage
Time frame: From delivery until neonatal hospital discharge, assessed up to 2 months
Number of Participants With Neonatal Necrotizing Enterocolitis
Time frame: From delivery to neonatal discharge, assessed up to 2 months
Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days
Time frame: From birth to discharge form delivery hospital, assessed up to 2 months
Length of Latency Assessed as Number of Days
Time frame: From rupture of membranes until delivery, assessed up to 34 weeks of gestation
| Milestone | 17-hydroxyprogesterone Caproate | Castor Oil Injections |
|---|---|---|
| Started | 10 | 11 |
| Completed | 10 | 11 |
| Not completed | 0 | 0 |
Delayed delivery until 34 weeks gestation.
| Participants | 17-hydroxyprogesterone Caproate | Castor Oil Injections |
|---|---|---|
| Number of Participants With Achievement of 34 Weeks Gestation | 0 | 0 |
| Participants | 17-hydroxyprogesterone Caproate | Castor Oil Injections |
|---|---|---|
| Number of Participants With Neonatal Respiratory Distress Syndrome | 7 | 10 |
| Participants | 17-hydroxyprogesterone Caproate | Castor Oil Injections |
|---|---|---|
| Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage | 1 | 2 |
| Participants | 17-hydroxyprogesterone Caproate | Castor Oil Injections |
|---|---|---|
| Number of Participants With Neonatal Necrotizing Enterocolitis | 2 | 1 |
| days | 17-hydroxyprogesterone Caproate | Castor Oil Injections |
|---|---|---|
| Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days | 39 (13 to 59) | 50 (34 to 69) |
| days | 17-hydroxyprogesterone Caproate | Castor Oil Injections |
|---|---|---|
| Length of Latency Assessed as Number of Days | 14.5 (8.9 to 29.1) | 8 (5.3 to 13.4) |
Collected over From enrollment up to discharge from the delivery hospital, assessed up to 2 months after delivery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 17-hydroxyprogesterone Caproate | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Castor Oil Injections | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(years) | 17-hydroxyprogesterone Caproate | Castor Oil Injections | Total |
|---|---|---|---|
| Mean | 31.7 ± 1.9 | 31.7 ± 2.0 | 31.7 ± 1.95 |
| Sex: Female, Male(Participants) | 17-hydroxyprogesterone Caproate | Castor Oil Injections | Total |
|---|---|---|---|
| Female | 10 | 11 | 21 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | 17-hydroxyprogesterone Caproate | Castor Oil Injections | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 8 | 15 |
| Not Hispanic or Latino | 3 | 2 | 5 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | 17-hydroxyprogesterone Caproate | Castor Oil Injections | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 5 | 6 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 5 | 8 |
| Region of Enrollment(Participants) | 17-hydroxyprogesterone Caproate | Castor Oil Injections | Total |
|---|---|---|---|
| United States | 10 | 11 | 21 |
| History of prior preterm birth(Participants) | 17-hydroxyprogesterone Caproate | Castor Oil Injections | Total |
|---|---|---|---|
| Count of participants | 3 | 0 | 3 |
Plan to share: No
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