Trial · NCT00615550
PREGNANT Short Cervix Trial
NCT00615550, Phase 3, Completed, Juniper Pharmaceuticals, Inc.; results first posted 2012-03-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PREGNANT Short Cervix Trial. Trials, record NCT00615550. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00615550
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PREGNANT Short Cervix Trial
- NCT number
- NCT00615550
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 465 participants, actual
- Lead sponsor
- Juniper Pharmaceuticals, Inc.
- Conditions
- Preterm Delivery, Short Cervix, Short Uterine Cervical Length
- Interventions
- progesterone, placebo
- First posted
- 2008-02-14
- Last updated
- 2012-03-13
- Results first posted
- 2012-03-13
- Limitations and caveats
- Trial not powered for subgroup analysis.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Birth <=32 6/7 Weeks Gestation. | 9 to 13 weeks | |
| Secondary | Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC) | Delivery Hospitalization (1-212 days) | Each infant is scored based on the 7 morbidity and mortality events above: 0= no morbidity event 1. 1 morbidity event 2. 2 morbidity events 3. 3 or more morbidity events 4. mortality |
| Secondary | Number of Subjects With Preterm Birth at ≤27 6/7, ≤34 6/7, and <36 6/7 Weeks Gestation. | Gestational Age at Delivery | Number of participants at \<=27 6/7 , \<=34 6/7, and \<36 6/7. |
| Secondary | Number of Neonates Who Died. | Delivery to 28 days | |
| Secondary | Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams | date of delivery | Assessment of birth weight \< 1500 grams or \< 2500 grams |
Source ClinicalTrials.gov
Outcomes5
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 Birth <=32 6/7 Weeks Gestation. | 9 to 13 weeks | Intent to Treat | participants | NUMBER |
| SECONDARY | Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC) | Delivery Hospitalization (1-212 days) | participants | NUMBER | |
| SECONDARY | Number of Subjects With Preterm Birth at ≤27 6/7, ≤34 6/7, and <36 6/7 Weeks Gestation. | Gestational Age at Delivery | Intent to Treat | participants | NUMBER |
| SECONDARY | Number of Neonates Who Died. | Delivery to 28 days | All infants with a known delivery date and status. | participants | NUMBER |
| SECONDARY | Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams | date of delivery | Available birth weight. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
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 Birth <=32 6/7 Weeks Gestation. | Placebo | 36 | participants | ||
| Number of Participants With Birth <=32 6/7 Weeks Gestation. | Prochieve | 21 | participants | ||
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC) | Placebo | Composite score 0 | 192 | participants | |
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC) | Prochieve | Composite score 0 | 217 | participants | |
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC) | Placebo | Composite score 1 | 11 | participants | |
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC) | Prochieve | Composite score 1 | 5 | participants | |
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC) | Placebo | Composite score 2 | 8 | participants | |
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC) | Prochieve | Composite score 2 | 2 | participants | |
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC) | Placebo | Composite score 3 | 0 | participants | |
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC) | Prochieve | Composite score 3 | 3 | participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 229 | |
| Overall Study | STARTED | Prochieve | 236 | |
| Overall Study | COMPLETED | Placebo | 223 | |
| Overall Study | COMPLETED | Prochieve | 235 | |
| Overall Study | NOT COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Prochieve | 1 |
Source ClinicalTrials.gov
Adverse events146
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | abdominal pain | Gastrointestinal disorders | Placebo | 11 | 223 | 11 |
| other | abdominal pain | Gastrointestinal disorders | Prochieve | 13 | 235 | 13 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 12 | 223 | 12 |
| other | Dyspepsia | Gastrointestinal disorders | Prochieve | 15 | 235 | 15 |
| other | Nausea | Gastrointestinal disorders | Placebo | 23 | 223 | 23 |
| other | Nausea | Gastrointestinal disorders | Prochieve | 23 | 235 | 23 |
| other | Vaginitis bacterial | Infections and infestations | Placebo | 6 | 223 | 6 |
| other | Vaginitis bacterial | Infections and infestations | Prochieve | 12 | 235 | 12 |
| other | Vulvovaginal mycotic infection | Infections and infestations | Placebo | 11 | 223 | 11 |
| other | Vulvovaginal mycotic infection | Infections and infestations | Prochieve | 17 | 235 | 17 |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Prochieve | ||
| Total, other adverse events | Placebo | 24 | 223 |
| Total, other adverse events | Prochieve | 30 | 235 |
| Total, serious adverse events | Placebo | 98 | 224 |
| Total, serious adverse events | Prochieve | 97 | 235 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prochieve vs Placebo: Number of Neonates Who Died. | Trial comparisons |
| Prochieve vs Placebo: Number of Participants With Birth <=32 6/7 Weeks Gestation. | Trial comparisons |
| Prochieve vs Placebo: 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/NCT00615550
GET https://conductscience.org/api/trials/v1/NCT00615550/results?page=2