Primary outcomeMean· 24 hrs
Rate of Induction To Delivery
| Group | Value (minutes) | Spread |
|---|---|---|
| Oxytocin | 732.19 | 236.99 |
| Misoprostol | 944.35 | 317.78 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataCervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon
NCTNCT01139801 (opens ClinicalTrials.gov in a new tab)Other id2009 ED
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 50 participants (actual)
- Sponsor
- Aultman Health Foundation · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Sept 2009
- Primary completion
- Mar 2010
- Completion
- Mar 2010
- First posted
- 9 Jun 2010 (estimated)
- Last update posted
- 24 Aug 2018
- Conditions
- Induction of Labor
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200920102011
- N/A
Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon
NCT01139801Sept 2009 to Mar 2010
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.
Interventions
- OxytocinDrug
- MisoprostolDrug
Arms2
Active comparator
Oxytocin
Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
Experimental
Misoprostol
Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
Primary outcomes1
Outcomes the sponsor listed as primary.
Rate of Induction To Delivery
Time frame · 24 hrs
Registry description
To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times
Secondary outcomes(1)
Delivery Route
Time frame · 24 hrs
Registry description
To assess for differences in delivery routes
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeCount of participants· 24 hrs
Delivery Route
| Group | Value (Participants) |
|---|---|
| Oxytocin | 16 |
| Misoprostol | 17 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| OxytocinFoley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute. | 0 / 25 | 0 / 25 | 0 / 25 |
| MisoprostolMisoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement | 0 / 25 | 0 / 25 | 0 / 25 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Participant or surrogate is capable of giving informed consent
* Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy
* Participant is undergoing an indicated induction of labor
* Participant is found to have cervical Bishop score ≤5 on initial cervical exam
* Participant has no medical or obstetrical contraindications to induction of labor
Exclusion Criteria:
* Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
* Manufacturer's contraindications to misoprostol or oxytocin
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