Trial · NCT03407625
Foley Bulb With Oral Misoprostol for Induction of Labor
NCT03407625, Not applicable, Completed, University of Texas Southwestern Medical Center; results first posted 2020-11-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Foley Bulb With Oral Misoprostol for Induction of Labor. Trials, record NCT03407625. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03407625
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Foley Bulb With Oral Misoprostol for Induction of Labor
- NCT number
- NCT03407625
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,227 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Pregnancy, Labor, Induced
- Interventions
- Foley bulb plus Oral Misoprostol, Oral Misoprostol
- First posted
- 2018-01-23
- Last updated
- 2020-11-04
- Results first posted
- 2020-11-04
- Limitations and caveats
Pre-specified outcomes (dose of Oxytocin give at the delivery, terbutaline use, and the number of participants with intravenous analgesia during labor) were not collected as they were found to be not meaningful.
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Vaginal Delivery | at delivery | vaginal delivery at first induction |
| Secondary | Time to Delivery | from start of induction agent to time of delivery | Time (in hours) from start of induction agent to delivery at first induction |
| Secondary | Indication for Cesarean Delivery | at delivery | Among women delivered by cesarean, the indication for cesarean |
| Secondary | Dose of Oxytocin Given (mcg or mg) | at delivery | Total dose of oxytocin given for induction as calculated by volume infused, concentration of solution and rate of infusion |
| Secondary | Time With Foley Bulb in Place | From time of documented insertion until the time of documented expulsion or removal, whichever came first, assessed up to 24 hours. | time (in hours) from insertion to removal or expulsion of foley bulb |
| Secondary | Presence of Chorioamnionitis | at delivery | Intrapartum fever (temp equal or greater than 38C) with no other identified cause |
| Secondary | Use of Intravenous Analgesia During Labor | at delivery | Intravenous analgesia used between the start of induction and delivery |
| Secondary | Number of Participants Used Neuraxial Analgesia During Labor | from start of induction to delivery | Regional or neuraxial analgesia (labor epidural or spinal) used between the start of induction and delivery |
| Secondary | Number of Participants Used General Anesthesia for Delivery | at delivery | General anesthesia administered for delivery |
| Secondary | Number of Participants With Meconium-stained Amniotic Fluid | At the time of rupture of membranes and at delivery | Identification of any meconium (green tinge) in the amniotic fluid before or during delivery by a healthcare provider's assessment of gross fluid color. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
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 Vaginal Delivery | at delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Delivery | from start of induction agent to time of delivery | This number represents women delivered at first induction | hours | MEAN |
| SECONDARY | Indication for Cesarean Delivery | at delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Dose of Oxytocin Given (mcg or mg) | at delivery | Total dose of oxytocin was not found to be meaningful, thus data were not collected. | ||
| SECONDARY | Time With Foley Bulb in Place | From time of documented insertion until the time of documented expulsion or removal, whichever came first, assessed up to 24 hours. | Number of women with successful Foley bulb placement | hours | MEDIAN |
| SECONDARY | Presence of Chorioamnionitis | at delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Use of Intravenous Analgesia During Labor | at delivery | Intravenous analgesia was not clinically meaningful and was not collected | ||
| SECONDARY | Number of Participants Used Neuraxial Analgesia During Labor | from start of induction to delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Used General Anesthesia for Delivery | at delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Meconium-stained Amniotic Fluid | At the time of rupture of membranes and at delivery | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group47
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 Vaginal Delivery | Foley Bulb Plus Oral Misoprostol | 869 | Participants | ||
| Number of Participants With Vaginal Delivery | Oral Misoprostol | 860 | Participants | ||
| Time to Delivery | Foley Bulb Plus Oral Misoprostol | 17.3 | Standard Deviation 9.2 | hours | |
| Time to Delivery | Oral Misoprostol | 18.2 | Standard Deviation 9.2 | hours | |
| Indication for Cesarean Delivery | Foley Bulb Plus Oral Misoprostol | Labor dystocia | 122 | Participants | |
| Indication for Cesarean Delivery | Oral Misoprostol | Labor dystocia | 110 | Participants | |
| Indication for Cesarean Delivery | Foley Bulb Plus Oral Misoprostol | Abnormal fetal heart rate tracing | 110 | Participants | |
| Indication for Cesarean Delivery | Oral Misoprostol | Abnormal fetal heart rate tracing | 115 | Participants | |
| Indication for Cesarean Delivery | Foley Bulb Plus Oral Misoprostol | Malpresentation | 3 | Participants | |
| Indication for Cesarean Delivery | Oral Misoprostol | Malpresentation | 3 | Participants |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Foley Bulb Plus Oral Misoprostol | 1,117 | |
| Overall Study | STARTED | Oral Misoprostol | 1,110 | |
| Overall Study | COMPLETED | Foley Bulb Plus Oral Misoprostol | 1,117 | |
| Overall Study | COMPLETED | Oral Misoprostol | 1,110 | |
| Overall Study | NOT COMPLETED | Foley Bulb Plus Oral Misoprostol | 0 | |
| Overall Study | NOT COMPLETED | Oral Misoprostol | 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 | Foley Bulb Plus Oral Misoprostol | 0 | 1,117 |
| Total, all-cause mortality | Oral Misoprostol | 0 | 1,110 |
| Total, other adverse events | Foley Bulb Plus Oral Misoprostol | 0 | 1,117 |
| Total, other adverse events | Oral Misoprostol | 0 | 1,110 |
| Total, serious adverse events | Foley Bulb Plus Oral Misoprostol | 0 | 1,117 |
| Total, serious adverse events | Oral Misoprostol | 0 | 1,110 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33030881 | 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 comparisons19
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Foley Bulb Plus Oral Misoprostol vs Oral Misoprostol: Number of Participants With an 5-minute Apgar Score Less Than 4 | Trial comparisons |
| Foley Bulb Plus Oral Misoprostol vs Oral Misoprostol: Number of Participants With Tachysystole | Trial comparisons |
| Foley Bulb Plus Oral Misoprostol vs Oral Misoprostol: Presence of Chorioamnionitis | Trial comparisons |
| Foley Bulb Plus Oral Misoprostol vs Oral Misoprostol: Number of Participants Used Neuraxial Analgesia During Labor | Trial comparisons |
| Foley Bulb Plus Oral Misoprostol vs Oral Misoprostol: Number of Participants With Uterine Hyperstimulation Syndrome | Trial comparisons |
| Foley Bulb Plus Oral Misoprostol vs Oral Misoprostol: Number of Participants With Meconium-stained Amniotic Fluid | Trial comparisons |
| Foley Bulb Plus Oral Misoprostol vs Oral Misoprostol: Number of Participants With Unplanned Hysterectomy | Trial comparisons |
| Foley Bulb Plus Oral Misoprostol vs Oral Misoprostol: Number of Participants With Neonatal Sepsis | Trial comparisons |
| Foley Bulb Plus Oral Misoprostol vs Oral Misoprostol: Number of Participants With NICU Admission Order | Trial comparisons |
| Foley Bulb Plus Oral Misoprostol vs Oral Misoprostol: Number of Participants With Uterine Rupture | Trial comparisons |
1 to 10 of 19
See all 19 trial comparisonsTests0
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/NCT03407625
GET https://conductscience.org/api/trials/v1/NCT03407625/registered?page=2