Perineal LacerationsNCT00652977
Ritgens Maneuver for the Prevention of Anal Sphincter Tears at Delivery: A Randomized Controlled Trial
A study testing Ritgens maneuver in people with Perineal Lacerations, run by Lund University Hospital at 2 sites in Sweden.
Trial summary
The aim of the investigation was to assess whether routine use of the modified Ritgen´s maneuver decreases the risk of anal sphincter injury at delivery, compared with simple manual protection of the perineum.Ritgen´s maneuver means that the fetal chin is reached for between the anus and the coccyx and pulled… Read more about this study
- Who is it for?
- Ages 16 to 44 years, women only
- Conditions the study is for
- Perineal Lacerations
- What is being tested?
- Ritgens maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,623 participants
- Where
- 2 sitesSweden
- Study dates
- Dec 1999to Jul 2001
- 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 to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women with singleton pregnancy and a fetus in cephalic presentation
- admitted for labor
- rupture of the membranes or induction after 37 completed gestational weeks
- and reaching full cervical dilatation.
Who cannot join
- Operative delivery
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Helsingborgs lasarett
Helsingborg, 25187
Lund Univeristy Hospital
Lund, 221 85
About this study
Official title: Modified Ritgens Maneuver for Perineal Protection at Delivery
The aim of the investigation was to assess whether routine use of the modified Ritgen´s maneuver decreases the risk of anal sphincter injury at delivery, compared with simple manual protection of the perineum.Ritgen´s maneuver means that the fetal chin is reached for between the anus and the coccyx and pulled anteriorly, while using the fingers of the other hand on the fetal occiput to control speed of delivery and keep flexion of the fetal neck.
Read the detailed description
This application is made retroactively - the study was performed during December 1st, 1999 to July 31st, 2001, at Lund University Hospital and Helsingborg Hospital. Primigravid women in the area were informed about the study at the maternity care centers, receiving written information in gestational week 36. Eligible for the study were women with singleton pregnancy and a fetus in cephalic presentation, admitted for labor, rupture of the membranes or induction after 37 completed gestational weeks. Primigravid women received written information about the study at the maternal health care centers, and eligible women were asked for consent at admission in labor.
Randomization was done at the beginning of the second stage of labor (at full cervical dilatation), in each unit by a telephone call from the delivering midwife to the other department, where randomization lists with numbers for allocation were kept. In women allocated to Ritgen´s maneuver, the protocol stated that the delivery of the fetal head should be managed by this maneuver, i.e. lifting the fetal chin anteriorly, using the fingers of one hand placed between the anus and the coccyx, and thereby extending the fetal neck, whereas the other hand should be placed on the fetal occiput to control the pace of the expulsion of the fetal head. The technique for Ritgen´s maneuver was standardized, and midwives that were unfamiliar with the procedure were instructed by senior colleagues before the trial. In the other study group, the protocol entailed our standard care. The standard practice at delivery was using one hand to apply pressure against the perineum, and the other hand on the fetal occiput to control the expulsion of the fetal head, and only to use Ritgen´s maneuver in case of labor arrest or abnormal fetal heart rate pattern when the fetal head was at the pelvic floor.
- Conditions
- Perineal Lacerations
- Being tested
- Ritgens maneuver, Standard care (Manual support of the perineum)
- Keywords
- sphincter tears, Ritgen maneuver, perineal tears, prevention, delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ritgens maneuverProcedure or surgery
Delivery of the fetal head should be managed by Ritgens maneuver, i.e. lifting the fetal chin anteriorly, using the fingers of one hand placed between the anus and the coccyx, and thereby extending the fetal neck, whereas the other hand should be placed on the fetal occiput to control the pace of the expulsion of the fetal head. The maneuver was used during a uterine contraction
Standard care (Manual support of the perineum)Procedure or surgery
The protocol entailed our standard care: using one hand to apply pressure against the perineum, and the other hand on the fetal occiput to control the expulsion of the fetal head, and only to use Ritgen´s maneuver in case of labor arrest or abnormal fetal heart rate pattern when the fetal head was at the pelvic floor.
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | The delivery of the fetal head should be managed by Ritgens maneuver, i.e. lifting the fetal chin anteriorly, using the fingers of one hand placed between the anus and the coccyx, and thereby extending the fetal neck, whereas the other hand should be placed on the fetal occiput to control the pace of the expulsion of the fetal head. Receives: Procedure: Ritgens maneuver |
| II | Other | Standard care at delivery: Manual support of the perineum Receives: Procedure: Standard care (Manual support of the perineum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perineal rupture grade III-IV (anal sphincter tears)
Measured: At delivery - within minutes - hours of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startDec 1999
- Primary completionJul 2001
- Study completionJul 2001
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 Perineal LacerationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Andreas Herbst, MD, PhD, Principal investigator, Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652977
- Sponsor's protocol ID
- Lu1-99
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 7 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Jonsson ER, Elfaghi I, Rydhstrom H, Herbst A. Modified Ritgen's maneuver for anal sphincter injury at delivery: a randomized controlled trial. Obstet Gynecol. 2008 Aug;112(2 Pt 1):212-7. doi: 10.1097/AOG.0b013e31817f2867.
PubMed 18669713
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Ritgens Maneuver for Perineal Protection at Delivery
- ClinicalTrials.gov ID
- NCT00652977
- Acronym / sponsor ID
- Lu1-99
- Conditions
- Perineal Lacerations
- Keywords
- sphincter tears, Ritgen maneuver, perineal tears, prevention, delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,623 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- Dec 1999
- Primary completion
- Jul 2001 (actual)
- Study completion
- Jul 2001 (actual)
- First posted
- 4 Apr 2008 (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 aim of the investigation was to assess whether routine use of the modified Ritgen´s maneuver decreases the risk of anal sphincter injury at delivery, compared with simple manual protection of the perineum.Ritgen´s maneuver means that the fetal chin is reached for between the anus and the coccyx and pulled anteriorly, while using the fingers of the other hand on the fetal occiput to control speed of delivery and keep flexion of the fetal neck.
Detailed description
This application is made retroactively - the study was performed during December 1st, 1999 to July 31st, 2001, at Lund University Hospital and Helsingborg Hospital. Primigravid women in the area were informed about the study at the maternity care centers, receiving written information in gestational week 36. Eligible for the study were women with singleton pregnancy and a fetus in cephalic presentation, admitted for labor, rupture of the membranes or induction after 37 completed gestational weeks. Primigravid women received written information about the study at the maternal health care centers, and eligible women were asked for consent at admission in labor.
Randomization was done at the beginning of the second stage of labor (at full cervical dilatation), in each unit by a telephone call from the delivering midwife to the other department, where randomization lists with numbers for allocation were kept. In women allocated to Ritgen´s maneuver, the protocol stated that the delivery of the fetal head should be managed by this maneuver, i.e. lifting the fetal chin anteriorly, using the fingers of one hand placed between the anus and the coccyx, and thereby extending the fetal neck, whereas the other hand should be placed on the fetal occiput to control the pace of the expulsion of the fetal head. The technique for Ritgen´s maneuver was standardized, and midwives that were unfamiliar with the procedure were instructed by senior colleagues before the trial. In the other study group, the protocol entailed our standard care. The standard practice at delivery was using one hand to apply pressure against the perineum, and the other hand on the fetal occiput to control the expulsion of the fetal head, and only to use Ritgen´s maneuver in case of labor arrest or abnormal fetal heart rate pattern when the fetal head was at the pelvic floor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Procedure: Ritgens maneuverThe delivery of the fetal head should be managed by Ritgens maneuver, i.e. lifting the fetal chin anteriorly, using the fingers of one hand placed between the anus and the coccyx, and thereby extending the fetal neck, whereas the other hand should be placed on the fetal occiput to control the pace of the expulsion of the fetal head. |
| II | Other | Procedure: Standard care (Manual support of the perineum)Standard care at delivery: Manual support of the perineum |
Who may qualify
- Ages
- 16 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Women with singleton pregnancy and a fetus in cephalic presentation
- admitted for labor
- rupture of the membranes or induction after 37 completed gestational weeks
- and reaching full cervical dilatation.
Key exclusion criteria (1 listed)
- Operative delivery
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 |
|---|---|---|
| Ritgens maneuverDelivery of the fetal head should be managed by Ritgens maneuver, i.e. lifting the fetal chin anteriorly, using the fingers of one hand placed between the anus and the coccyx, and thereby extending the fetal neck, whereas the other hand should be placed on the fetal occiput to control the pace of the expulsion of the fetal head. The maneuver was used during a uterine contraction | Procedure or surgery | I |
| Standard care (Manual support of the perineum)The protocol entailed our standard care: using one hand to apply pressure against the perineum, and the other hand on the fetal occiput to control the expulsion of the fetal head, and only to use Ritgen´s maneuver in case of labor arrest or abnormal fetal heart rate pattern when the fetal head was at the pelvic floor. | Procedure or surgery | II |
Primary outcome
Perineal rupture grade III-IV (anal sphincter tears)
Time frame: At delivery - within minutes - hours of randomization
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 7 Apr 2008.
- Derived from this study: PubMed 18669713Jonsson ER, Elfaghi I, Rydhstrom H, Herbst A. Modified Ritgen's maneuver for anal sphincter injury at delivery: a randomized controlled trial. Obstet Gynecol. 2008 Aug;112(2 Pt 1):212-7. doi: 10.1097/AOG.0b013e31817f2867.
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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.
Andreas Herbst, MD, PhD principal investigator
Lund University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ritgens maneuver in people with Perineal Lacerations, run by Lund University Hospital at 2 sites in Sweden.
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 4 inclusion and 1 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 7 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Perineal rupture grade III-IV (anal sphincter tears) (time frame: At delivery - within minutes - hours of randomization). 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 NCT00652977, 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 7 Apr 2008.