Trial · NCT01736852
Evaluation of CRB in PROM Patients
NCT01736852, Not applicable, Completed, Cook Group Incorporated; results first posted 2020-10-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of CRB in PROM Patients. Trials, record NCT01736852. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01736852
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of CRB in PROM Patients
- NCT number
- NCT01736852
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 129 participants, actual
- Lead sponsor
- Cook Group Incorporated
- Conditions
- Premature Rupture of Fetal Membranes
- Interventions
- CRB, Pitocin
- First posted
- 2012-11-29
- Last updated
- 2020-10-20
- Results first posted
- 2020-10-20
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time of Labor | Start of labor induction through delivery, an expected average of 6 hours | Time, in minutes, from the start of labor induction through delivery |
| Primary | Incidence of Infection | Through hospital discharge, an expected average of 3 days | number of patients with chorioamnionitis |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time of Labor | Start of labor induction through delivery, an expected average of 6 hours | Minutes | MEAN | |
| PRIMARY | Incidence of Infection | Through hospital discharge, an expected average of 3 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time of Labor | CRB Plus Pitocin | 850.4 | Standard Deviation 417.6 | Minutes | |
| Time of Labor | Pitocin | 1016.6 | Standard Deviation 595.7 | Minutes | |
| Incidence of Infection | CRB Plus Pitocin | 7 | Participants | ||
| Incidence of Infection | Pitocin | 6 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CRB Plus Pitocin | 65 | |
| Overall Study | STARTED | Pitocin | 64 | |
| Overall Study | COMPLETED | CRB Plus Pitocin | 63 | |
| Overall Study | COMPLETED | Pitocin | 61 | |
| Overall Study | NOT COMPLETED | CRB Plus Pitocin | 2 | |
| Overall Study | NOT COMPLETED | Pitocin | 3 |
Source ClinicalTrials.gov
Adverse events20
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 | Arrested Labor | Pregnancy, puerperium and perinatal conditions | CRB Plus Pitocin | 7 | 63 | 7 |
| other | Arrested Labor | Pregnancy, puerperium and perinatal conditions | Pitocin | 13 | 61 | 13 |
| other | Amniotic Cavity Infection | Infections and infestations | CRB Plus Pitocin | 7 | 63 | 7 |
| other | Amniotic Cavity Infection | Infections and infestations | Pitocin | 6 | 61 | 6 |
| other | Jaundice Neonatal | Pregnancy, puerperium and perinatal conditions | CRB Plus Pitocin | 14 | 63 | 14 |
| other | Jaundice Neonatal | Pregnancy, puerperium and perinatal conditions | Pitocin | 5 | 61 | 5 |
| serious | Jaundice Neonatal | Pregnancy, puerperium and perinatal conditions | CRB Plus Pitocin | 1 | 63 | 1 |
| serious | Jaundice Neonatal | Pregnancy, puerperium and perinatal conditions | Pitocin | 1 | 61 | 1 |
| serious | Neonatal Hypoxia | Respiratory, thoracic and mediastinal disorders | CRB Plus Pitocin | 0 | 63 | 0 |
| serious | Neonatal Hypoxia | Respiratory, thoracic and mediastinal disorders | Pitocin | 1 | 61 | 1 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CRB Plus Pitocin | 0 | 63 |
| Total, all-cause mortality | Pitocin | 0 | 61 |
| Total, other adverse events | CRB Plus Pitocin | 27 | 63 |
| Total, other adverse events | Pitocin | 21 | 61 |
| Total, serious adverse events | CRB Plus Pitocin | 5 | 63 |
| Total, serious adverse events | Pitocin | 4 | 61 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42424638 | DERIVED |
Source PubMed
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 |
|---|---|
| CRB Plus Pitocin vs Pitocin: Incidence of Infection | Trial comparisons |
| CRB Plus Pitocin vs Pitocin: deaths from any cause | Trial comparisons |
| CRB Plus Pitocin vs Pitocin: 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/NCT01736852
GET https://conductscience.org/api/trials/v1/NCT01736852/registered