Ritgens Maneuver for the Prevention of Anal Sphincter Tears at Delivery: A Randomized Controlled Trial
Modified Ritgens Maneuver for Perineal Protection at Delivery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Helsingborg, Sweden, 25187
- Helsingborgs lasarett
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Lund, Sweden, 221 85
- Lund Univeristy Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Operative delivery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: I
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.
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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
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Other: II
Standard care at delivery: Manual support of the perineum
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Perineal rupture grade III-IV (anal sphincter tears)
Time Frame: At delivery - within minutes - hours of randomization
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At delivery - within minutes - hours of randomization
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andreas Herbst, MD, PhD, Lund University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lu1-99
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