Trial · NCT01050647
Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
NCT01050647, Phase 1, Phase 2, Completed, Stanford University; results first posted 2018-04-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial. Trials, record NCT01050647. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01050647
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
- NCT number
- NCT01050647
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Pregnancy Complications
- Interventions
- 17-Hydroxyprogesterone Caproate, Caster Oil injections
- First posted
- 2010-01-15
- Last updated
- 2019-04-09
- Results first posted
- 2018-04-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Achievement of 34 Weeks Gestation | From enrollment until delivery, an average of 34 weeks | Delayed delivery until 34 weeks gestation. |
| Secondary | Number of Participants With Neonatal Respiratory Distress Syndrome | From delivery until neonatal hospital discharge, assessed up to 2 months | |
| Secondary | Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage | From delivery until neonatal hospital discharge, assessed up to 2 months | |
| Secondary | Number of Participants With Neonatal Necrotizing Enterocolitis | From delivery to neonatal discharge, assessed up to 2 months | |
| Secondary | 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 | |
| Secondary | Length of Latency Assessed as Number of Days | From rupture of membranes until delivery, assessed up to 34 weeks of gestation |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Achievement of 34 Weeks Gestation | From enrollment until delivery, an average of 34 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Neonatal Respiratory Distress Syndrome | From delivery until neonatal hospital discharge, assessed up to 2 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage | From delivery until neonatal hospital discharge, assessed up to 2 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Neonatal Necrotizing Enterocolitis | From delivery to neonatal discharge, assessed up to 2 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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 | days | MEAN | |
| SECONDARY | Length of Latency Assessed as Number of Days | From rupture of membranes until delivery, assessed up to 34 weeks of gestation | days | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Achievement of 34 Weeks Gestation | 17-hydroxyprogesterone Caproate | 0 | Participants | ||
| Number of Participants With Achievement of 34 Weeks Gestation | Castor Oil Injections | 0 | Participants | ||
| Number of Participants With Neonatal Respiratory Distress Syndrome | 17-hydroxyprogesterone Caproate | 7 | Participants | ||
| Number of Participants With Neonatal Respiratory Distress Syndrome | Castor Oil Injections | 10 | Participants | ||
| Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage | 17-hydroxyprogesterone Caproate | 1 | Participants | ||
| Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage | Castor Oil Injections | 2 | Participants | ||
| Number of Participants With Neonatal Necrotizing Enterocolitis | 17-hydroxyprogesterone Caproate | 2 | Participants | ||
| Number of Participants With Neonatal Necrotizing Enterocolitis | Castor Oil Injections | 1 | Participants | ||
| Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days | 17-hydroxyprogesterone Caproate | 39 | 95% Confidence Interval 13 to 59 | days | |
| Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days | Castor Oil Injections | 50 | 95% Confidence Interval 34 to 69 | days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 17-hydroxyprogesterone Caproate | 10 | |
| Overall Study | STARTED | Castor Oil Injections | 11 | |
| Overall Study | COMPLETED | 17-hydroxyprogesterone Caproate | 10 | |
| Overall Study | COMPLETED | Castor Oil Injections | 11 | |
| Overall Study | NOT COMPLETED | 17-hydroxyprogesterone Caproate | 0 | |
| Overall Study | NOT COMPLETED | Castor Oil Injections | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 17-hydroxyprogesterone Caproate | 0 | 10 |
| Total, all-cause mortality | Castor Oil Injections | 0 | 11 |
| Total, other adverse events | 17-hydroxyprogesterone Caproate | 0 | 10 |
| Total, other adverse events | Castor Oil Injections | 0 | 11 |
| Total, serious adverse events | 17-hydroxyprogesterone Caproate | 0 | 10 |
| Total, serious adverse events | Castor Oil Injections | 0 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 17-hydroxyprogesterone Caproate vs Castor Oil Injections: Number of Participants With Achievement of 34 Weeks Gestation | Trial comparisons |
| 17-hydroxyprogesterone Caproate vs Castor Oil Injections: Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage | Trial comparisons |
| 17-hydroxyprogesterone Caproate vs Castor Oil Injections: Number of Participants With Neonatal Necrotizing Enterocolitis | Trial comparisons |
| 17-hydroxyprogesterone Caproate vs Castor Oil Injections: Number of Participants With Neonatal Respiratory Distress Syndrome | Trial comparisons |
| 17-hydroxyprogesterone Caproate vs Castor Oil Injections: deaths from any cause | Trial comparisons |
| 17-hydroxyprogesterone Caproate vs Castor Oil Injections: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01050647
GET https://conductscience.org/api/trials/v1/NCT01050647/registered