Labor, Second Stagecath2stageNCT02198157
Urinary Catheterization and Second Stage of Labor
A study testing urinary catheterization in people with Labor, Second Stage, run by Raed Salim at 1 site in Israel.
Trial summary
Labor is divided into three stages: the first stage is from labor onset until full dilation, second stage is from full dilation until delivery of the baby, and the third stage from the delivery of the baby until the delivery of the placenta The mean duration of second stage in nulliparas as defined by the American… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Second Stage
- What is being tested?
- urinary catheterization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2014to Jul 2015
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous women
- Gestational age 24-42 weeks
- epidural anaesthesia
- Vertex presentation
- Singleton
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intermittent Versus Continuous Bladder Catheterization During Labor on Second Stage Duration
- Labor is divided into three stages: the first stage is from labor onset until full dilation, second stage is from full dilation until delivery of the baby, and the third stage from the delivery of the baby until the delivery of the placenta
- The mean duration of second stage in nulliparas as defined by the American college of obstetricians and gynecologists (ACOG) is 54 minutes
- Epidural anesthesia is a known cause for prolongation of the second stage of labor. Prolonged second stage in nullipara women with epidural is defined as more than 3 hours, and more than 2 hours in those without epidural.
- Although perinatal outcome is not compromised with a prolonged second stage , there is evidence that maternal morbidities such as perineal trauma, chorioamnionitis ,instrumental delivery and postpartum hemorrhage increase with prolonged second stage
- Another effect of epidural anesthesia during labor is urinary retention and a need for catheterization.
- Full bladder may behave as a tumor previa and interfere to fetal head descent in the birth canal, increasing by that the duration of the second stage.
- This study aims to investigate the effect of intermittent versus continuous catheterization on the duration of the second stage of labor
- Conditions
- Labor, Second Stage
- Being tested
- urinary catheterization
- Keywords
- duration of second stage, urinary catheterization, epidural anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary catheterizationOther
Also called continuous versus intermittent catheterization.
nullipara women with epidural anaesthesia who pose urination difficulty will be randomize to receive intermittent or continuous urinary catheterization.
| Study group | Role | What they receive |
|---|---|---|
| intermittent urinary catheterization | Active comparator | nullipara women with epidural anaesthesia who pose urination difficulty will receive intermittent catheterization Receives: Other: urinary catheterization |
| continuous urinary catheter | Active comparator | nullipara women with epidural anaesthesia who pose urination difficulty will receive continuous catheterization Receives: Other: urinary catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of second stage of labor
Measured: within the first 48 hours after delivery
Secondary outcomes (1)
chorioamnionitis
Measured: within the first 48 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, Second StageStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raed Salim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raed Salim, HaEmek Medical Center, Israel
- Investigators
- raed salim, MD, Study director, Dep. OB/GYN, HaEmek Medical Center, Afula, Israelabeer suleiman, MD, Principal investigator, Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198157
- Sponsor's protocol ID
- 45-14-EMC
- Acronym
- cath2stage
- Status last verified
- Feb 2016
- First submitted
- 21 Jul 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Versus Continuous Bladder Catheterization During Labor on Second Stage Duration
- ClinicalTrials.gov ID
- NCT02198157
- Acronym / sponsor ID
- cath2stage / 45-14-EMC
- Conditions
- Labor, Second Stage
- Keywords
- duration of second stage, urinary catheterization, epidural anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Raed SalimUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 Jul 2014 (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.
- Labor is divided into three stages: the first stage is from labor onset until full dilation, second stage is from full dilation until delivery of the baby, and the third stage from the delivery of the baby until the delivery of the placenta
- The mean duration of second stage in nulliparas as defined by the American college of obstetricians and gynecologists (ACOG) is 54 minutes
- Epidural anesthesia is a known cause for prolongation of the second stage of labor. Prolonged second stage in nullipara women with epidural is defined as more than 3 hours, and more than 2 hours in those without epidural.
- Although perinatal outcome is not compromised with a prolonged second stage , there is evidence that maternal morbidities such as perineal trauma, chorioamnionitis ,instrumental delivery and postpartum hemorrhage increase with prolonged second stage
- Another effect of epidural anesthesia during labor is urinary retention and a need for catheterization.
- Full bladder may behave as a tumor previa and interfere to fetal head descent in the birth canal, increasing by that the duration of the second stage.
- This study aims to investigate the effect of intermittent versus continuous catheterization on the duration of the second stage of labor
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intermittent urinary catheterization | Active comparator | Other: urinary catheterizationnullipara women with epidural anaesthesia who pose urination difficulty will receive intermittent catheterization |
| continuous urinary catheter | Active comparator | Other: urinary catheterizationnullipara women with epidural anaesthesia who pose urination difficulty will receive continuous catheterization |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Nulliparous women
- Gestational age 24-42 weeks
- epidural anaesthesia
- Vertex presentation
- Singleton
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| urinary catheterizationAlso: continuous versus intermittent catheterization.nullipara women with epidural anaesthesia who pose urination difficulty will be randomize to receive intermittent or continuous urinary catheterization. | Other | continuous urinary catheter, intermittent urinary catheterization |
Primary outcome
duration of second stage of labor
Time frame: within the first 48 hours after delivery
1 secondary outcome
chorioamnionitis
Time frame: within the first 48 hours after delivery
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 23 Feb 2016.
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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.
raed salim, MD study director
Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
abeer suleiman, MD principal investigator
Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urinary catheterization in people with Labor, Second Stage, run by Raed Salim at 1 site in Israel.
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 0 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 23 Feb 2016. 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 Israel. 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.
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?
duration of second stage of labor (time frame: within the first 48 hours after delivery). 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 23 Feb 2016; AzTrials last refreshed its copy on 1 Nov 2026.