Perineal LacerationsNCT00895973
A Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations
A study testing Stirrups delivery vs bed delivery in people with Perineal Lacerations, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The investigators hypothesize that the rate of perineal lacerations in nulliparous women will be reduced by a simple change in common obstetrical delivery practice, i.e., bed delivery versus conventional delivery in obstetrical stirrups. 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
- Perineal Lacerations
- What is being tested?
- Stirrups delivery vs bed delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jan 2010
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nulliparous women presenting in active labor to Parkland L\&D East Unit
- ≥ 370/7 weeks gestation
- Singleton fetus in cephalic presentation
- ≥ 4 cm but ≤ 8 cm of cervical dilation
- No medical or obstetrical complication
Who cannot join
- Women with any obstetric or medical complication of pregnancy, such as pregnancy related hypertension, diabetes, labor induction
- Prior history of perineal trauma requiring surgical repair or known congenital perineal malformation
- Non-English or non-Spanish speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations
The investigators hypothesize that the rate of perineal lacerations in nulliparous women will be reduced by a simple change in common obstetrical delivery practice, i.e., bed delivery versus conventional delivery in obstetrical stirrups.
Read the detailed description
This is a randomized controlled trial of bed delivery in the supine position versus conventional delivery in obstetrical stirrups. It will include nulliparous women presenting in active labor to the L\&D East (low risk) Unit at Parkland Hospital, > 370/7 weeks gestation, with singleton fetuses in cephalic presentation. The primary outcome variable is any perineal laceration. Secondary outcomes measures include (1) 3rd or 4th degree lacerations and (2) any lacerations in subgroup comparisons between study arms.
- Conditions
- Perineal Lacerations
- Being tested
- Stirrups delivery vs bed delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stirrups delivery vs bed deliveryOther
Position of legs at time of vaginal delivery (bed vs stirrups)
| Study group | Role | What they receive |
|---|---|---|
| Stirrups delivery | Experimental | Mom will be assigned to deliver with legs positioned in stirrups Receives: Other: Stirrups delivery vs bed delivery |
| Bed delivery | Experimental | Mom will be assigned to deliver with the legs positioned in bed in the supine position Receives: Other: Stirrups delivery vs bed delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any perineal laceration (first through fourth degree)
Measured: Immediately post delivery
Secondary outcomes (1)
Third and fourth-degree perineal lacerations
Measured: Immediately post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal LacerationsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlene Corton, University of Texas Southwestern Medical Center
- Investigators
- Marlene M Corton, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895973
- Sponsor's protocol ID
- 072008-053
- Status last verified
- Nov 2018
- First submitted
- 8 May 2009
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations
- ClinicalTrials.gov ID
- NCT00895973
- Acronym / sponsor ID
- 072008-053
- Conditions
- Perineal Lacerations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 11 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.
The investigators hypothesize that the rate of perineal lacerations in nulliparous women will be reduced by a simple change in common obstetrical delivery practice, i.e., bed delivery versus conventional delivery in obstetrical stirrups.
Detailed description
This is a randomized controlled trial of bed delivery in the supine position versus conventional delivery in obstetrical stirrups. It will include nulliparous women presenting in active labor to the L\&D East (low risk) Unit at Parkland Hospital, > 370/7 weeks gestation, with singleton fetuses in cephalic presentation. The primary outcome variable is any perineal laceration. Secondary outcomes measures include (1) 3rd or 4th degree lacerations and (2) any lacerations in subgroup comparisons between study arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stirrups delivery | Experimental | Other: Stirrups delivery vs bed deliveryMom will be assigned to deliver with legs positioned in stirrups |
| Bed delivery | Experimental | Other: Stirrups delivery vs bed deliveryMom will be assigned to deliver with the legs positioned in bed in the supine position |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Nulliparous women presenting in active labor to Parkland L\&D East Unit
- ≥ 370/7 weeks gestation
- Singleton fetus in cephalic presentation
- ≥ 4 cm but ≤ 8 cm of cervical dilation
- No medical or obstetrical complication
Key exclusion criteria (3 listed)
- Women with any obstetric or medical complication of pregnancy, such as pregnancy related hypertension, diabetes, labor induction
- Prior history of perineal trauma requiring surgical repair or known congenital perineal malformation
- Non-English or non-Spanish speaking
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 |
|---|---|---|
| Stirrups delivery vs bed deliveryPosition of legs at time of vaginal delivery (bed vs stirrups) | Other | Bed delivery, Stirrups delivery |
Primary outcome
Any perineal laceration (first through fourth degree)
Time frame: Immediately post delivery
1 secondary outcome
Third and fourth-degree perineal lacerations
Time frame: Immediately post 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 19 Nov 2018.
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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.
Marlene M Corton, MD 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 study testing Stirrups delivery vs bed delivery in people with Perineal Lacerations, 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 3 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 19 Nov 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. 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?
Any perineal laceration (first through fourth degree) (time frame: Immediately post 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 19 Nov 2018.