Labor ComplicationsNCT02101515
Randomized Control Trial of Second Stage of Labor
A study testing Length of Second Stage in people with Labor Complications, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The hypothesis of this study is that extending the second stage of labor beyond current American College of Obstetricians and Gynecologists suggestions can reduce the cesarean delivery rate. The cesarean delivery rate in the United States is around 30 percent. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Complications
- What is being tested?
- Length of Second Stage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jul 2015
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nulliparous women
- singleton pregnancies
- cephalic presentation
- 36.0-41.6 weeks
- age 18 and older
Who cannot join
- Category 3 fetal heart tracing
- major congenital anomalies
- multiples
- planned cesarean delivery
- intrauterine fetal demise
- Trial of labor after cesarean
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hosptial
Philadelphia, Pennsylvania, 19107
About this study
Official title: Randomized Control Trial of Usual Labor Versus Extended Second Stage
The hypothesis of this study is that extending the second stage of labor beyond current American College of Obstetricians and Gynecologists suggestions can reduce the cesarean delivery rate. The cesarean delivery rate in the United States is around 30 percent. This is a number that continues to be increasing over the last few decades and will continue to climb. Each subsequent cesarean section puts the mother and baby at increased risk for postpartum hemorrhage, bowel and bladder injury, abnormal placentation, febrile morbidity and death. The most common reason for a cesarean delivery is a repeat cesarean delivery. One way to reduce this number is to prevent the first cesarean delivery. The aim of this study is evaluate if extending the second stage of labor affects the cesarean delivery rate and subsequent perinatal morbidity.
Read the detailed description
- Consent at the time of admission or in the office
- 2nd stage starts at full dilation
- Randomization occurs at 2 hours without epidural or 3 hours with epidural, stratified by epidural status
- Randomization scheme is according to a predetermined computer-generated block randomization scheme with block sizes of 6,8 and12 (random blocks).
- Sequentially numbered and sealed opaque envelopes prepared according to the randomization scheme and delivered to a secure container in labor and delivery suite to maintain concealed treatment allocation.
- At the 3 hour mark, the next number envelope is pulled and opened by the physician/nurse to reveal the designated group. At this point the patient is considered randomized.
- Provider preference for cesarean delivery, operative vaginal delivery, continued pushing, with intention-to-treat analysis
- Those that require cesarean delivery - usual perioperative management
- Early termination criteria: emergency cesarean delivery, category 3 fetal heart tracing
- Conditions
- Labor Complications
- Being tested
- Length of Second Stage
- Keywords
- randomized controlled trial, labor complications, cesarean section, second stage
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Length of Second StageOther
The experimental group will have one additional hour in the second stage of labor
| Study group | Role | What they receive |
|---|---|---|
| Usual Labor | Placebo comparator | Immediate delivery after 3 hours with epidural or 2 hours without epidural Receives: Other: Length of Second Stage |
| Extended | Experimental | Immediate delivery after 4 hours with an epidural or 3 hours without an epidural
Intervention: one additional hour for the second stage of labor
Length of second stage in extended arm is 3 hours without epidural and 4 hours with epidural. Receives: Other: Length of Second Stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Delivered by Cesarean
Number of patients delivered by cesarean delivery for the extended labor group
Measured: At time of delivery, up to 4 hours of the second stage for "Extended group" and 3 hours for "Usual group"
Secondary outcomes (2)
Number of Newborns With Umbilical Artery pH < 7.10
Umbilical artery pH is a marker for adverse neurological outcomes. Umbilical artery pH <7.10 has been proposed as a threshold for identifying fetuses who might develop pathologic fetal acidosis and fetal injury.
Measured: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Postpartum Hemorrhage
Number of participants who experienced a postpartum hemorrhage
Measured: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2015
- Study completionJul 2015
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 (2)Papers the sponsor has linked to this study.
- Other trials for Labor ComplicationsStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alexis gimovsky, Thomas Jefferson University
- Investigators
- Alexis Gimovsky, MD, Principal investigator, Thomas Jefferson UniversityVincenzo Berghella, MD, Study chair, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101515
- Sponsor's protocol ID
- 13D.590
- Status last verified
- Jan 2018
- First submitted
- 28 Mar 2014
- Last updated
- 26 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Please contact Dr. Gimovsky at agimovsky@mfa.gwu.edu
Publications
Gimovsky AC, Phillips JM, Amero M, Levine J, Berghella V. Prolonged second stage effect on pelvic floor dysfunction: a follow up survey to a randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):5520-5525. doi: 10.1080/14767058.2021.1887122. Epub 2021 Feb 14.
PubMed 33586572Gimovsky AC, Berghella V. Randomized controlled trial of prolonged second stage: extending the time limit vs usual guidelines. Am J Obstet Gynecol. 2016 Mar;214(3):361.e1-6. doi: 10.1016/j.ajog.2015.12.042.
PubMed 26928148
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Usual Labor Versus Extended Second Stage
- ClinicalTrials.gov ID
- NCT02101515
- Acronym / sponsor ID
- 13D.590
- Conditions
- Labor Complications
- Keywords
- randomized controlled trial, labor complications, cesarean section, second stage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Posted 26 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study is that extending the second stage of labor beyond current American College of Obstetricians and Gynecologists suggestions can reduce the cesarean delivery rate. The cesarean delivery rate in the United States is around 30 percent. This is a number that continues to be increasing over the last few decades and will continue to climb. Each subsequent cesarean section puts the mother and baby at increased risk for postpartum hemorrhage, bowel and bladder injury, abnormal placentation, febrile morbidity and death. The most common reason for a cesarean delivery is a repeat cesarean delivery. One way to reduce this number is to prevent the first cesarean delivery. The aim of this study is evaluate if extending the second stage of labor affects the cesarean delivery rate and subsequent perinatal morbidity.
Detailed description
- Consent at the time of admission or in the office
- 2nd stage starts at full dilation
- Randomization occurs at 2 hours without epidural or 3 hours with epidural, stratified by epidural status
- Randomization scheme is according to a predetermined computer-generated block randomization scheme with block sizes of 6,8 and12 (random blocks).
- Sequentially numbered and sealed opaque envelopes prepared according to the randomization scheme and delivered to a secure container in labor and delivery suite to maintain concealed treatment allocation.
- At the 3 hour mark, the next number envelope is pulled and opened by the physician/nurse to reveal the designated group. At this point the patient is considered randomized.
- Provider preference for cesarean delivery, operative vaginal delivery, continued pushing, with intention-to-treat analysis
- Those that require cesarean delivery - usual perioperative management
- Early termination criteria: emergency cesarean delivery, category 3 fetal heart tracing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Labor | Placebo comparator | Other: Length of Second StageImmediate delivery after 3 hours with epidural or 2 hours without epidural |
| Extended | Experimental | Other: Length of Second StageImmediate delivery after 4 hours with an epidural or 3 hours without an epidural Intervention: one additional hour for the second stage of labor Length of second stage in extended arm is 3 hours without epidural and 4 hours with epidural. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Nulliparous women
- singleton pregnancies
- cephalic presentation
- 36.0-41.6 weeks
- age 18 and older
Key exclusion criteria (6 listed)
- Category 3 fetal heart tracing
- major congenital anomalies
- multiples
- planned cesarean delivery
- intrauterine fetal demise
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 |
|---|---|---|
| Length of Second StageThe experimental group will have one additional hour in the second stage of labor | Other | Extended, Usual Labor |
Primary outcome
Number of Patients Delivered by Cesarean
Time frame: At time of delivery, up to 4 hours of the second stage for "Extended group" and 3 hours for "Usual group"
Number of patients delivered by cesarean delivery for the extended labor group
2 secondary outcomes
Number of Newborns With Umbilical Artery pH < 7.10
Time frame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Postpartum Hemorrhage
Time frame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33586572Gimovsky AC, Phillips JM, Amero M, Levine J, Berghella V. Prolonged second stage effect on pelvic floor dysfunction: a follow up survey to a randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):5520-5525. doi: 10.1080/14767058.2021.1887122. Epub 2021 Feb 14.
- Derived from this study: PubMed 26928148Gimovsky AC, Berghella V. Randomized controlled trial of prolonged second stage: extending the time limit vs usual guidelines. Am J Obstet Gynecol. 2016 Mar;214(3):361.e1-6. doi: 10.1016/j.ajog.2015.12.042.
- Individual participant dataSharing planned: Undecided. Please contact Dr. Gimovsky at agimovsky@mfa.gwu.edu
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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.
Alexis Gimovsky, MD principal investigator
Thomas Jefferson University
Vincenzo Berghella, MD study chair
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Length of Second Stage in people with Labor Complications, run by Thomas Jefferson University 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 26 Oct 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2018). 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?
Number of Patients Delivered by Cesarean (time frame: At time of delivery, up to 4 hours of the second stage for "Extended group" and 3 hours for "Usual group"). 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 NCT02101515, which also lists 2 linked publications.
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 26 Oct 2018.