Labor ComplicationNCT03752879
The Association Between Kristeller Maneuver and Pelvic Floor Trauma After Vaginal Delivery
An observational study of Labor Complication and Avulsion, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
We want to investigate the association between fundal pressure in the second stage and the risk of levator ani muscle (LAM) injury. 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 Complication, Avulsion
- What is being tested?
- Fundal Pressure
- Type of treatment
- Surgery or procedure
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2019to 18 Oct 2019
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Over 18 years old ,term primiparous women with singleton pregnancies and vaginal delivery.
Who may be able to join
- First delivery
- Term pregnancy (37-41w)
Who cannot join
- Instrumental vaginal delivery
- Multifetal pregnancy
- Previous vaginal or cesarean delivery
- Refused consent and uncooperative patient for effective Valsalva maneuver
- Handicap in lithotomy position
- Women without regular and active contractions
- Epidural analgesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University Hospital
Istanbul, 34093
About this study
Official title: The Association Between Fundal Pressure in Second Stage of Labor (Kristeller Maneuver) and and Pelvic Floor Trauma After Vaginal Delivery
We want to investigate the association between fundal pressure in the second stage and the risk of levator ani muscle (LAM) injury.
Read the detailed description
We will recruit women immediately following their first vaginal delivery. Women who underwent Kristeller maneuver will be recruit as cases. For each case, a control (no fundal pressure) will be recruit matched by BMI, second stage duration and birthweight. All women will be invited to undergo a postpartum 3D transperineal ultrasound (TPUS). The main outcome measure will be the presence of LAM avulsion at 3D TPUS. TPUS results will be compared between cases and controls.
- Conditions
- Labor Complication, Avulsion
- Being tested
- Fundal Pressure
- Keywords
- Kristeller maneuver,LAM avulsion,3D transperineal ultrasoun
- Medical subject headings
- Obstetric Labor Complications, Fractures, Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fundal PressureProcedure or surgery
Fundal Pressure to assist the vaginal delivery to shorten the second stage of labor
| Study group | Role | What they receive |
|---|---|---|
| Case (Kristaller Group) | Group of kristeller maneuver applied in the second stage of labor due to clinical necessity. Receives: Procedure: Fundal Pressure | |
| Control (no Kristaller Group) | The control group not required to kristeller maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
levator ani muscle (LAM) injury
The aim of the study is to investigate levator ani muscle (LAM) injury, loss of tenting, biometric measurements of LAM and genital hiatus after vaginal delivery and investigate the association between fundal pressure in the second stage of labor (Kristeller maneuver).
All recruited women will be invited to undergo a transperineal 3D ultrasound (TPUS) scan at 24 hours after delivery. we will acquire two 3D volumes for each patient: one under maximum pelvic floor muscle contraction (PFMC) and the other under maximum Valsalva's maneuver. Ballooning" will diagnosed with a pelvic hiatal area of more than 25 cm2 during maximum Valsalva. A complete avulsion of the puborectalis muscle will diagnose if an abnormal insertion of the muscle will be detected on all three central slices. We will use a levator-urethral gap more than 2.5 cm to define an abnormal insertion.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start18 May 2019
- Primary completion18 Jul 2019
- Study completion18 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor ComplicationStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752879
- Sponsor's protocol ID
- BezmialemVU Fundal Pressure
- Status last verified
- May 2020
- First submitted
- 20 Nov 2018
- Last updated
- 28 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Takmaz T, Aydin S, Gorchiyeva I, Karasu AFG. The usual suspect: cross-sectional study of fundal pressure at second stage of delivery and the association with pelvic floor damage. Int Urogynecol J. 2021 Jul;32(7):1917-1924. doi: 10.1007/s00192-020-04523-x. Epub 2020 Sep 9.
PubMed 32902763
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Fundal Pressure in Second Stage of Labor (Kristeller Maneuver) and and Pelvic Floor Trauma After Vaginal Delivery
- ClinicalTrials.gov ID
- NCT03752879
- Acronym / sponsor ID
- BezmialemVU Fundal Pressure
- Conditions
- Labor Complication, Avulsion
- Keywords
- Kristeller maneuver,LAM avulsion,3D transperineal ultrasoun
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 18 May 2019 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 26 Nov 2018 (actual)
- 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.
We want to investigate the association between fundal pressure in the second stage and the risk of levator ani muscle (LAM) injury.
Detailed description
We will recruit women immediately following their first vaginal delivery. Women who underwent Kristeller maneuver will be recruit as cases. For each case, a control (no fundal pressure) will be recruit matched by BMI, second stage duration and birthweight. All women will be invited to undergo a postpartum 3D transperineal ultrasound (TPUS). The main outcome measure will be the presence of LAM avulsion at 3D TPUS. TPUS results will be compared between cases and controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case (Kristaller Group) | – | Procedure: Fundal PressureGroup of kristeller maneuver applied in the second stage of labor due to clinical necessity. |
| Control (no Kristaller Group) | – | –The control group not required to kristeller maneuver |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Over 18 years old ,term primiparous women with singleton pregnancies and vaginal delivery.
Key inclusion criteria (2 listed)
- First delivery
- Term pregnancy (37-41w)
Key exclusion criteria (7 listed)
- Instrumental vaginal delivery
- Multifetal pregnancy
- Previous vaginal or cesarean delivery
- Refused consent and uncooperative patient for effective Valsalva maneuver
- Handicap in lithotomy position
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 |
|---|---|---|
| Fundal PressureFundal Pressure to assist the vaginal delivery to shorten the second stage of labor | Procedure or surgery | Case (Kristaller Group) |
Primary outcome
levator ani muscle (LAM) injury
Time frame: 24 hour
The aim of the study is to investigate levator ani muscle (LAM) injury, loss of tenting, biometric measurements of LAM and genital hiatus after vaginal delivery and investigate the association between fundal pressure in the second stage of labor (Kristeller maneuver). All recruited women will be invited to undergo a transperineal 3D ultrasound (TPUS) scan at 24 hours after delivery. we will acquire two 3D volumes for each patient: one under maximum pelvic floor muscle contraction (PFMC) and the other under maximum Valsalva's maneuver. Ballooning" will diagnosed with a pelvic hiatal area of more than 25 cm2 during maximum Valsalva. A complete avulsion of the puborectalis muscle will diagnose if an abnormal insertion of the muscle will be detected on all three central slices. We will use a levator-urethral gap more than 2.5 cm to define an abnormal insertion.
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 28 May 2020.
- Derived from this study: PubMed 32902763Takmaz T, Aydin S, Gorchiyeva I, Karasu AFG. The usual suspect: cross-sectional study of fundal pressure at second stage of delivery and the association with pelvic floor damage. Int Urogynecol J. 2021 Jul;32(7):1917-1924. doi: 10.1007/s00192-020-04523-x. Epub 2020 Sep 9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Complication and Avulsion, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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 28 May 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 Turkey (Türkiye). 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?
levator ani muscle (LAM) injury (time frame: 24 hour). 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 NCT03752879, 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 28 May 2020.