PregnancyPhase 4BUPNCT01621230
Effects of Bupivacaine Induced Motor Blockade During the Second Stage of Labor
A Phase 4 study testing Epidural Bupivacaine plus fentanyl and Epidural fentanyl in people with Pregnancy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The aim of this study is to measure the effects of bupivacaine administered via epidural catheters on indices of motor blockade ascertained during the second stage of labor. This is a randomized, double-blind, controlled trial designed to address the primary research question: Does bupivacaine lengthen the second… Read more about this study
- Who is it for?
- Ages 16 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Epidural Bupivacaine plus fentanyl and Epidural fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 481 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2013
- 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 to 44 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Nulliparous women at 37 weeks gestation or greater.
- Scheduled for induction of labor for any indication, to include hypertensive disorders, diabetes, decreased fetal motion, or prolonged pregnancy.
- Single without known malformations.
- Maternal age > or equal to 16 years.
- ASA classification 1 or 2.
Who cannot join
- Women who refuse epidural analgesia.
- Women with contraindications to epidural analgesia, i.e., severe thrombocytopenia.
- Any renal disease with serum creatinine > 1.0 mg/dL.
- Allergy to bupivacaine or fentanyl.
- Known liver disease such as hepatitis.
- Known contraindications to internal electronic fetal monitoring i.e., active herpes, maternal HIV seropositivity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health and Hospital System
Dallas, Texas, 75235
About this study
Official title: A Randomized Double-blinded Trial of the Effects of Bupivacaine Induced Motor Blockade on the Second Stage of Labor
The aim of this study is to measure the effects of bupivacaine administered via epidural catheters on indices of motor blockade ascertained during the second stage of labor. This is a randomized, double-blind, controlled trial designed to address the primary research question: Does bupivacaine lengthen the second stage of labor? The secondary research question is: Is there other evidence of motor blockade attributable to bupivacaine during the second stage of labor?
The investigators know from prior studies that the length of the second stage in nulliparous women delivered at Parkland Hospital without epidural analgesia is 28 minutes. The investigators hypothesize in this now proposed study that epidural analgesia with bupivacaine will significantly increase this baseline from 28 minutes to 37 minutes or more (a 33% increase) thus implicating motor blockade. Baseline data for the Bromage and Breen scores during the second stage as well as the uterine contractility data are not available as these indices of motor blockade have not here-to-fore been studied in this context.
Currently at Parkland Hospital, 82% of nulliparous women undergoing induction of labor at term receive continuous epidural infusions with bupivacaine during the first and second stages of labor. Such women will be identified when admitted for scheduled inductions at Parkland. After informed consent is obtained standard management of labor induction will be provided. Those consented women reaching 8 cm cervical dilation will be randomized. Group I will receive bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10 cm dilation) and Group II will receive only fentanyl infusion via epidural catheter (see study procedure below). Both the patient and the caregiver will be blinded as to whether the patient is in the bupivacaine plus fentanyl arm or the fentanyl only arm. To detect a 33% increase (from 28 minutes to 37 minutes) in the primary outcome the investigators need a total of 310 women enrolled in the study (or 155 per arm). Assuming a 30% consent rate and given that approximately 1000 women meet the inclusion criteria each year at Parkland, the investigators project that this study could be completed in 12 months.
Read the detailed description
Nulliparous women scheduled for labor inductions on Monday through Friday and who have consented to this study will be randomized to one of two arms: bupivacaine plus fentanyl epidural analgesia throughout labor and delivery (including the second stage) or epidural bupivacaine plus fentanyl until 8 cm cervical dilation and only fentanyl thereafter. From activation of epidural analgesia to 8 cm cervical dilation the prevailing standard epidural technique in use at Parkland Hospital will be used. Briefly, 19-ga multi-orifice epidural catheter is placed using 17-ga 3 ½cm Tuohy needle into the L3-L4 lumbar interspace. Lactated Ringers solution, 500-1000mL will be infused during placement of the epidural catheter to mitigate hypotension. A test dose using 1.5% lidocaine with 1:200,000 epinephrine, 3mL, will be given via the epidural catheter. If the test dose is negative, then an initial bolus of 0.25% bupivacaine, 4-8mL, with fentanyl 100mcg is given via the catheter. After securing the epidural catheter the patient will be placed in the supine position and the anesthetic sensory level measured with the desired level of T6-T8. Once a T6-T8 sensory block is secured the epidural infusion using 0.125% bupivacaine with 2mcg/mL fentanyl at 10mL/hr will be started.
At any time during epidural infusion the epidural catheter may be replaced at the discretion of the anesthesia provider for inadequate analgesia. Ephedrine or phenylephrine will be given intravenously for maternal hypotension defined as systolic blood pressure ≤ 90 mmHg or a decrease of 20% systolic blood pressure from patient's baseline.
Randomization will occur when the woman reaches 8 cm cervical dilation. Envelopes containing cassettes will be sequentially randomized by Dr. McIntire and given to the attending obstetrical anesthesiologist containing one of two medications. Group I will receive a 100mL epidural cassette of 0.125% bupivacaine with fentanyl 2mcg/mL to be infused at 10mL/hr. Group II will receive a 100mL cassette of fentanyl 10mcg/mL (to be infused at 10mL/hr. Both groups will have the same rate of epidural infusion such that the patient, nurse, obstetrician, and anesthesia providers will be blinded to the randomized treatment group. The Parkland Investigational Drug Service (IDS) will provide the study drugs.
The patient may request a 5mL bolus from the epidural infusion every 30 minutes if pain relief is inadequate. The obstetrician can also give patients in either study group 25mg of intravenous meperidine every hour for up to two doses if pain relief is unsatisfactory. The study regimen will continue until spontaneous delivery of the infant or until which time operative vaginal delivery or cesarean delivery is planned. At this point the study will be over and routine anesthesia care resumed.
The standard of care for management of labor induction at Parkland requires continuous electronic fetal heart rate monitoring (EFM) as well as uterine contraction monitoring. The standard is to apply EFM internal transducers when the membranes are ruptured. Standard fetal monitors equipped with laptop computers will be used to electronically store the fetal heart rate and uterine contraction data during this study. This will permit qualification of uterine contractility during the second stage of labor. The Bromage and Breen scores for motor blockade will be assessed at complete cervical dilation and at 30, 60, and 90 minutes thereafter. The scoring system is as follows:
Score Criteria
- Unable to move feet or knees (complete block)
- Able to move feet only
- Just able to move knees
- Detectable weakness of hip flexion while supine
- No weakness of hip flexion
- Able to perform partial knee bend
Visual analog pain (VAS) scores for the adequacy of epidural analgesia from 1-10 will also be assessed at each time point used for the Bromage and Breen scores.
Data collection will include maternal demographic characteristics as well as antepartum and intrapartum obstetrical features. Condition of the infant at birth based on Apgar scores and umbilical artery blood pH, as well as neonatal outcomes will be ascertained.
- Conditions
- Pregnancy
- Being tested
- Epidural Bupivacaine plus fentanyl, Epidural fentanyl
- Keywords
- Bupivacaine, Fentanyl, Epidural, Second Stage of Labor, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Bupivacaine plus fentanylDrug
Also called Epidural continous infusion of bupivacaine and fentanyl
The subjects will receive 0.125% bupivacaine with fentanyl 2 mcg/mL at a rate of 10 mL/hr.
Epidural fentanylDrug
Also called Epidural continous infusion of fentanyl
The subjects will receive epidural fentanyl 10 mcg/mL with the rate of 10mL/hr.
| Study group | Role | What they receive |
|---|---|---|
| Epidural fentanyl | Active comparator | A continuous epidural infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 ml/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 mL/hr for pain. Meperidine 25 mg intravenously every 1 hour for breakthrough pain as needed. Receives: Drug: Epidural fentanyl |
| Epidural bupivacaine plus fentanyl | Placebo comparator | A continuous epidural infusion of bupivacaine plus fentanyl during the second stage (i.e. 10 cm dilation) of labor. Epidural infusion are 10 ml/hr basal infusion plus 5 ml/hr demand dose via patient-controlled epidural analgesia (PCEA). Meperidine 25 mg intravenously every 1 hour for breakthrough pain as needed . Receives: Drug: Epidural Bupivacaine plus fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Duration of the Second Stage of Labor
The length of the second stage of labor (measured as minutes a parturient spends in Stage II) in nulliparous women received a epidural bupivacaine plus fentanyl or fentanyl alone.
Measured: Duration of second stage of labor approximately 30 minutes to 150 minutes
Secondary outcomes (4)
Local Anesthetic Motor Blockade Indices During Stage II of Labor
Motor blockade will be estimated using Bromage and Breen scores (measured on a 6-point standardized scale, 1= Unable to more feet, 6= Able to perform partial knee bend) that estimate motor blockade. This scoring system is based upon the laboring womans' ability to move her lower extremities.
Measured: Duration of second stage of labor approximately 30 minutes to 150 minutes
Mode of Delivery in Women Randomized to Bupivacaine vs. No Bupivacaine During the Second Stage of Labor
Measured: At the time of Delivery
Number of Participants Whose Newborns Received an APGAR Score of <=3 at 1 Min
Number of participants whose newborns received an APGAR score of <=3 at 1 min. A lower APGAR score represents poor health or a worsening in the Outcome,
Measured: At the time of Delivery, up to 3 hours
Number of Participants Whose Newborns Received an APGAR Score of <=3 at 5 Min
Number of participants whose newborns received an APGAR score of <=3 at 5 minutes. A lower APGAR score represents poor health or a worsening in the Outcome
Measured: At the time of Delivery, up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startSep 2009
- Primary completionJul 2012
- Study completionJul 2013
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 PregnancyStudies 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
- Model description
- double-blinded 2 arm
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Craig, University of Texas Southwestern Medical Center
- Investigators
- Kenneth Leveno, MD, Study chair, University of Texas Southwestern Medical CenterLisa Moseley, Study director, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621230
- Sponsor's protocol ID
- STU 042011-045
- Acronym
- BUP
- Status last verified
- Aug 2020
- First submitted
- 6 Feb 2012
- Last updated
- 24 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Craig MG, Grant EN, Tao W, McIntire DD, Leveno KJ. A randomized control trial of bupivacaine and fentanyl versus fentanyl-only for epidural analgesia during the second stage of labor. Anesthesiology. 2015 Jan;122(1):172-7. doi: 10.1097/ALN.0000000000000454.
PubMed 25254902
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blinded Trial of the Effects of Bupivacaine Induced Motor Blockade on the Second Stage of Labor
- ClinicalTrials.gov ID
- NCT01621230
- Acronym / sponsor ID
- BUP / STU 042011-045
- Conditions
- Pregnancy
- Keywords
- Bupivacaine, Fentanyl, Epidural, Second Stage of Labor, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 481 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Posted 24 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to measure the effects of bupivacaine administered via epidural catheters on indices of motor blockade ascertained during the second stage of labor. This is a randomized, double-blind, controlled trial designed to address the primary research question: Does bupivacaine lengthen the second stage of labor? The secondary research question is: Is there other evidence of motor blockade attributable to bupivacaine during the second stage of labor?
The investigators know from prior studies that the length of the second stage in nulliparous women delivered at Parkland Hospital without epidural analgesia is 28 minutes. The investigators hypothesize in this now proposed study that epidural analgesia with bupivacaine will significantly increase this baseline from 28 minutes to 37 minutes or more (a 33% increase) thus implicating motor blockade. Baseline data for the Bromage and Breen scores during the second stage as well as the uterine contractility data are not available as these indices of motor blockade have not here-to-fore been studied in this context.
Currently at Parkland Hospital, 82% of nulliparous women undergoing induction of labor at term receive continuous epidural infusions with bupivacaine during the first and second stages of labor. Such women will be identified when admitted for scheduled inductions at Parkland. After informed consent is obtained standard management of labor induction will be provided. Those consented women reaching 8 cm cervical dilation will be randomized. Group I will receive bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10 cm dilation) and Group II will receive only fentanyl infusion via epidural catheter (see study procedure below). Both the patient and the caregiver will be blinded as to whether the patient is in the bupivacaine plus fentanyl arm or the fentanyl only arm. To detect a 33% increase (from 28 minutes to 37 minutes) in the primary outcome the investigators need a total of 310 women enrolled in the study (or 155 per arm). Assuming a 30% consent rate and given that approximately 1000 women meet the inclusion criteria each year at Parkland, the investigators project that this study could be completed in 12 months.
Detailed description
Nulliparous women scheduled for labor inductions on Monday through Friday and who have consented to this study will be randomized to one of two arms: bupivacaine plus fentanyl epidural analgesia throughout labor and delivery (including the second stage) or epidural bupivacaine plus fentanyl until 8 cm cervical dilation and only fentanyl thereafter. From activation of epidural analgesia to 8 cm cervical dilation the prevailing standard epidural technique in use at Parkland Hospital will be used. Briefly, 19-ga multi-orifice epidural catheter is placed using 17-ga 3 ½cm Tuohy needle into the L3-L4 lumbar interspace. Lactated Ringers solution, 500-1000mL will be infused during placement of the epidural catheter to mitigate hypotension. A test dose using 1.5% lidocaine with 1:200,000 epinephrine, 3mL, will be given via the epidural catheter. If the test dose is negative, then an initial bolus of 0.25% bupivacaine, 4-8mL, with fentanyl 100mcg is given via the catheter. After securing the epidural catheter the patient will be placed in the supine position and the anesthetic sensory level measured with the desired level of T6-T8. Once a T6-T8 sensory block is secured the epidural infusion using 0.125% bupivacaine with 2mcg/mL fentanyl at 10mL/hr will be started.
At any time during epidural infusion the epidural catheter may be replaced at the discretion of the anesthesia provider for inadequate analgesia. Ephedrine or phenylephrine will be given intravenously for maternal hypotension defined as systolic blood pressure ≤ 90 mmHg or a decrease of 20% systolic blood pressure from patient's baseline.
Randomization will occur when the woman reaches 8 cm cervical dilation. Envelopes containing cassettes will be sequentially randomized by Dr. McIntire and given to the attending obstetrical anesthesiologist containing one of two medications. Group I will receive a 100mL epidural cassette of 0.125% bupivacaine with fentanyl 2mcg/mL to be infused at 10mL/hr. Group II will receive a 100mL cassette of fentanyl 10mcg/mL (to be infused at 10mL/hr. Both groups will have the same rate of epidural infusion such that the patient, nurse, obstetrician, and anesthesia providers will be blinded to the randomized treatment group. The Parkland Investigational Drug Service (IDS) will provide the study drugs.
The patient may request a 5mL bolus from the epidural infusion every 30 minutes if pain relief is inadequate. The obstetrician can also give patients in either study group 25mg of intravenous meperidine every hour for up to two doses if pain relief is unsatisfactory. The study regimen will continue until spontaneous delivery of the infant or until which time operative vaginal delivery or cesarean delivery is planned. At this point the study will be over and routine anesthesia care resumed.
The standard of care for management of labor induction at Parkland requires continuous electronic fetal heart rate monitoring (EFM) as well as uterine contraction monitoring. The standard is to apply EFM internal transducers when the membranes are ruptured. Standard fetal monitors equipped with laptop computers will be used to electronically store the fetal heart rate and uterine contraction data during this study. This will permit qualification of uterine contractility during the second stage of labor. The Bromage and Breen scores for motor blockade will be assessed at complete cervical dilation and at 30, 60, and 90 minutes thereafter. The scoring system is as follows:
Score Criteria
- Unable to move feet or knees (complete block)
- Able to move feet only
- Just able to move knees
- Detectable weakness of hip flexion while supine
- No weakness of hip flexion
- Able to perform partial knee bend
Visual analog pain (VAS) scores for the adequacy of epidural analgesia from 1-10 will also be assessed at each time point used for the Bromage and Breen scores.
Data collection will include maternal demographic characteristics as well as antepartum and intrapartum obstetrical features. Condition of the infant at birth based on Apgar scores and umbilical artery blood pH, as well as neonatal outcomes will be ascertained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double-blinded 2 arm
| Arm | Type | Receives |
|---|---|---|
| Epidural fentanyl | Active comparator | Drug: Epidural fentanylA continuous epidural infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 ml/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 mL/hr for pain. Meperidine 25 mg intravenously every 1 hour for breakthrough pain as needed. |
| Epidural bupivacaine plus fentanyl | Placebo comparator | Drug: Epidural Bupivacaine plus fentanylA continuous epidural infusion of bupivacaine plus fentanyl during the second stage (i.e. 10 cm dilation) of labor. Epidural infusion are 10 ml/hr basal infusion plus 5 ml/hr demand dose via patient-controlled epidural analgesia (PCEA). Meperidine 25 mg intravenously every 1 hour for breakthrough pain as needed . |
Who may qualify
- Ages
- 16 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Nulliparous women at 37 weeks gestation or greater.
- Scheduled for induction of labor for any indication, to include hypertensive disorders, diabetes, decreased fetal motion, or prolonged pregnancy.
- Single without known malformations.
- Maternal age > or equal to 16 years.
- ASA classification 1 or 2.
Key exclusion criteria (6 listed)
- Women who refuse epidural analgesia.
- Women with contraindications to epidural analgesia, i.e., severe thrombocytopenia.
- Any renal disease with serum creatinine > 1.0 mg/dL.
- Allergy to bupivacaine or fentanyl.
- Known liver disease such as hepatitis.
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 |
|---|---|---|
| Epidural Bupivacaine plus fentanylAlso: Epidural continous infusion of bupivacaine and fentanylThe subjects will receive 0.125% bupivacaine with fentanyl 2 mcg/mL at a rate of 10 mL/hr. | Drug | Epidural bupivacaine plus fentanyl |
| Epidural fentanylAlso: Epidural continous infusion of fentanylThe subjects will receive epidural fentanyl 10 mcg/mL with the rate of 10mL/hr. | Drug | Epidural fentanyl |
Primary outcome
The Duration of the Second Stage of Labor
Time frame: Duration of second stage of labor approximately 30 minutes to 150 minutes
The length of the second stage of labor (measured as minutes a parturient spends in Stage II) in nulliparous women received a epidural bupivacaine plus fentanyl or fentanyl alone.
4 secondary outcomes
Local Anesthetic Motor Blockade Indices During Stage II of Labor
Time frame: Duration of second stage of labor approximately 30 minutes to 150 minutes
Mode of Delivery in Women Randomized to Bupivacaine vs. No Bupivacaine During the Second Stage of Labor
Time frame: At the time of Delivery
Number of Participants Whose Newborns Received an APGAR Score of <=3 at 1 Min
Time frame: At the time of Delivery, up to 3 hours
Number of Participants Whose Newborns Received an APGAR Score of <=3 at 5 Min
Time frame: At the time of Delivery, up to 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25254902Craig MG, Grant EN, Tao W, McIntire DD, Leveno KJ. A randomized control trial of bupivacaine and fentanyl versus fentanyl-only for epidural analgesia during the second stage of labor. Anesthesiology. 2015 Jan;122(1):172-7. doi: 10.1097/ALN.0000000000000454.
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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.
Kenneth Leveno, MD study chair
University of Texas Southwestern Medical Center
Lisa Moseley 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 Epidural Bupivacaine plus fentanyl and Epidural fentanyl in people with Pregnancy, 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 5 inclusion and 6 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 24 Aug 2020. 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. Some participants in this study may receive a placebo. 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 24 Aug 2020). 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?
The Duration of the Second Stage of Labor (time frame: Duration of second stage of labor approximately 30 minutes to 150 minutes). 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 NCT01621230, 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 24 Aug 2020.