Arrest of Dilation in LaborPhase 1NCT00906126
Oral Misoprostol for Labor Augmentation: A Pilot Study
A Phase 1 study testing Misoprostol in people with Arrest of Dilation in Labor, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
A phase I, open-label trial to determine a safe dose of oral misoprostol required to augment labor in nulliparous women diagnosed with arrest of dilation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Arrest of Dilation in Labor
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to May 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- nulliparous
- gestational age of at least 36 weeks
- singleton gestation
- cephalic presentation
- reassuring fetal heart rate
- 4 cm or greater cervical dilation
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- ruptured membranes with clear amnionic fluid
- intrauterine pressure catheter in place
- less than 200 MVU's
Who cannot join
- non-reassuring fetal heart rate
- meconium-stained amnionic fluid
- previous uterine incision
- maternal fever
- pregnancy-induced hypertension or other pregnancy-related complications
- known fetal anomalies
Show all 11Show fewer
- placenta previa or unexplained vaginal bleeding
- estimated fetal weight of 4,500 grams or greater
- evidence of cephalopelvic disproportion
- any moderate or severe preexisting disease
- contraindication to the use of prostaglandins
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Oral Misoprostol for Labor Augmentation: A Dose-Finding Pilot Study
A phase I, open-label trial to determine a safe dose of oral misoprostol required to augment labor in nulliparous women diagnosed with arrest of dilation.
- Conditions
- Arrest of Dilation in Labor
- Being tested
- Misoprostol
- Keywords
- oral misoprostol, labor augmentation, arrest of dilation, nulliparous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
Oral misoprostol
| Study group | Role | What they receive |
|---|---|---|
| Oral Misoprostol 1 | Experimental | Oral misoprostol 25 micrograms every 4 hours for up to two doses. Receives: Drug: Misoprostol |
| Oral Misoprostol 2 | Experimental | Oral misoprostol 50 micrograms every 4 hours for up to two doses. Receives: Drug: Misoprostol |
| Oral Misoprostol 3 | Experimental | Oral misoprostol 100 micrograms every 4 hours for up to two doses. Receives: Drug: Misoprostol |
| Oral Misoprostol 4 | Experimental | Oral Misoprostol 50 micrograms every 2 hours for up to two doses. Receives: Drug: Misoprostol |
| Oral Misoprostol 5 | Experimental | Oral Misoprostol 75 micrograms every 4 hours for up to two doses. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
uterine hyperstimulation
Secondary outcomes (6)
adequate uterine activity
need for oxytocin augmentation
time from administration of study drug to delivery
route of delivery and indications
maternal and neonatal infectious morbidity
neonatal outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startApr 2007
- Primary completionSep 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrest of Dilation in LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Kathryn S Villano, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906126
- Sponsor's protocol ID
- 122006051
- Status last verified
- May 2009
- First submitted
- 19 May 2009
- Last updated
- 21 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Misoprostol for Labor Augmentation: A Dose-Finding Pilot Study
- ClinicalTrials.gov ID
- NCT00906126
- Acronym / sponsor ID
- 122006051
- Conditions
- Arrest of Dilation in Labor
- Keywords
- oral misoprostol, labor augmentation, arrest of dilation, nulliparous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase I, open-label trial to determine a safe dose of oral misoprostol required to augment labor in nulliparous women diagnosed with arrest of dilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Oral Misoprostol 1 | Experimental | Drug: MisoprostolOral misoprostol 25 micrograms every 4 hours for up to two doses. |
| Oral Misoprostol 2 | Experimental | Drug: MisoprostolOral misoprostol 50 micrograms every 4 hours for up to two doses. |
| Oral Misoprostol 3 | Experimental | Drug: MisoprostolOral misoprostol 100 micrograms every 4 hours for up to two doses. |
| Oral Misoprostol 4 | Experimental | Drug: MisoprostolOral Misoprostol 50 micrograms every 2 hours for up to two doses. |
| Oral Misoprostol 5 | Experimental | Drug: MisoprostolOral Misoprostol 75 micrograms every 4 hours for up to two doses. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- nulliparous
- gestational age of at least 36 weeks
- singleton gestation
- cephalic presentation
- reassuring fetal heart rate
Key exclusion criteria (11 listed)
- non-reassuring fetal heart rate
- meconium-stained amnionic fluid
- previous uterine incision
- maternal fever
- pregnancy-induced hypertension or other pregnancy-related complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolAlso: CytotecOral misoprostol | Drug | Oral Misoprostol 1, Oral Misoprostol 2, Oral Misoprostol 3, Oral Misoprostol 4, Oral Misoprostol 5 |
Primary outcome
uterine hyperstimulation
6 secondary outcomes
adequate uterine activity
need for oxytocin augmentation
time from administration of study drug to delivery
route of delivery and indications
maternal and neonatal infectious morbidity
neonatal outcomes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn S Villano, M.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Misoprostol in people with Arrest of Dilation in Labor, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uterine hyperstimulation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2009.