Labor AugmentationPhase 4NCT00906347
A Trial of Oral Misoprostol for Labor Augmentation
A Phase 4 study testing Misoprostol and Oxytocin in people with Labor Augmentation, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Augmentation
- What is being tested?
- Misoprostol and Oxytocin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jan 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinical decision to augment labor
- Gestational age > than or equal to 36 weeks
- Singleton gestation
- Cephalic presentation
- Reassuring fetal heart rate tracing
- Cervical dilation between 4 and 8 cm
Show all 11Show fewer
- Ruptured membranes with clear amniotic fluid
- Intrauterine pressure catheter in place
- Less than 200 MVUs in a 10 minute period
- 5 or fewer contractions in a 10 minute period
- English or Spanish speaking patient
Who cannot join
- Non-reassuring fetal heart rate tracing at time of enrollment
- Meconium stained amniotic fluid
- Previous uterine incision
- Maternal fever (defined as greater than 37.9 C)
- Known fetal anomalies
- Placenta previa or unexplained vaginal bleeding
Show all 9Show fewer
- Estimated fetal weight of 4,500 grams or more
- Abnormal maternal bony pelvis
- Grandmultiparity
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: A Randomized, Controlled Trial of Oral Misoprostol for Labor Augmentation
This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.
- Conditions
- Labor Augmentation
- Being tested
- Misoprostol, Oxytocin
- Keywords
- Labor augmentation, Oral misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
75 micrograms orally every 4 hours for up to 2 doses.
OxytocinDrug
Also called Pitocin
Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin augmentation | Active comparator | Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin. Receives: Drug: Oxytocin |
| Misoprostol augmentation | Active comparator | Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine Tachysystole
Defined as six contractions in two consecutive 10-minute periods
Measured: Up to four hours after administration of study drug
Secondary outcomes (7)
Infant Apgar Score <4
Assigned on a scale of 0-10 by pediatric provider attending delivery. A lower score reflects need for further resuscitation and is potentially associated with increased risk of adverse neurological outcomes.
Measured: 5 minutes after delivery
Umbilical Cord Artery pH <7.1
Measured: Obtained at delivery
Admission of Neonatal Intensive Care Unit
Measured: Until hospital discharge
Maternal Chorioamnionitis
Temperature 38 degrees C or higher in the absence of other sources of infection
Measured: During labor
Maternal Hypovolemia Requiring Blood Transfusion
Measured: Until hospital discharge
Method of Delivery
Measured: At delivery
Time Elapsed From Start of Labor Augmentation to Delivery
Measured: Initiation of augmentation until delivery
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 startDec 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor AugmentationStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- April Bleich, MD, Principal investigator, University of Texas Southwestern Medical CenterKenneth Leveno, MD, Study director, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906347
- Sponsor's protocol ID
- 102008-030
- Status last verified
- May 2009
- First submitted
- 19 May 2009
- Last updated
- 15 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bleich AT, Villano KS, Lo JY, Alexander JM, McIntire DD, Leveno KJ. Oral misoprostol for labor augmentation: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1255-1260. doi: 10.1097/AOG.0b013e318236df5b.
PubMed 22105254
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Oral Misoprostol for Labor Augmentation
- ClinicalTrials.gov ID
- NCT00906347
- Acronym / sponsor ID
- 102008-030
- Conditions
- Labor Augmentation
- Keywords
- Labor augmentation, Oral misoprostol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Posted 7 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin augmentation | Active comparator | Drug: OxytocinWomen with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin. |
| Misoprostol augmentation | Active comparator | Drug: MisoprostolWomen with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Clinical decision to augment labor
- Gestational age > than or equal to 36 weeks
- Singleton gestation
- Cephalic presentation
- Reassuring fetal heart rate tracing
Key exclusion criteria (9 listed)
- Non-reassuring fetal heart rate tracing at time of enrollment
- Meconium stained amniotic fluid
- Previous uterine incision
- Maternal fever (defined as greater than 37.9 C)
- Known fetal anomalies
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: Cytotec75 micrograms orally every 4 hours for up to 2 doses. | Drug | Misoprostol augmentation |
| OxytocinAlso: PitocinIntravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital | Drug | Oxytocin augmentation |
Primary outcome
Uterine Tachysystole
Time frame: Up to four hours after administration of study drug
Defined as six contractions in two consecutive 10-minute periods
7 secondary outcomes
Infant Apgar Score <4
Time frame: 5 minutes after delivery
Umbilical Cord Artery pH <7.1
Time frame: Obtained at delivery
Admission of Neonatal Intensive Care Unit
Time frame: Until hospital discharge
Maternal Chorioamnionitis
Time frame: During labor
Maternal Hypovolemia Requiring Blood Transfusion
Time frame: Until hospital discharge
Method of Delivery
Time frame: At delivery
Time Elapsed From Start of Labor Augmentation to Delivery
Time frame: Initiation of augmentation until delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22105254Bleich AT, Villano KS, Lo JY, Alexander JM, McIntire DD, Leveno KJ. Oral misoprostol for labor augmentation: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1255-1260. doi: 10.1097/AOG.0b013e318236df5b.
Related trials for Labor Augmentation
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Calcium Carbonate to Augment Labor Contractions
Labor Dystocia, Labor Induction
Not yet recruitingPhase 4
Comparing High Versus Low Dose of Oxytocin, in Gravida Women With BMI 30 and Above Which Are Undergoing Induction of Labor
Induction of Labor, Augmentation of Labor
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.
April Bleich, MD principal investigator
University of Texas Southwestern Medical Center
Kenneth Leveno, MD study director
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 4 study testing Misoprostol and Oxytocin in people with Labor Augmentation, 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 11 inclusion and 9 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 15 Nov 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Tachysystole (time frame: Up to four hours after administration of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00906347, which also lists 1 linked publication.
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 15 Nov 2012.