Ritgens Maneuver for the Prevention of Anal Sphincter Tears at Delivery: A Randomized Controlled Trial

This study has been completed.
Sponsor:
Information provided by:
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT00652977
First received: April 1, 2008
Last updated: April 4, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention
Perineal Lacerations
Procedure: Ritgens maneuver
Procedure: Standard care (Manual support of the perineum)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Modified Ritgens Maneuver for Perineal Protection at Delivery

Further study details as provided by Lund University Hospital:

Primary Outcome Measures:
  • Perineal rupture grade III-IV (anal sphincter tears) [ Time Frame: At delivery - within minutes - hours of randomization ] [ Designated as safety issue: No ]

Enrollment: 1623
Study Start Date: December 1999
Study Completion Date: July 2001
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Ritgens maneuver
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
II
Standard care at delivery: Manual support of the perineum
Procedure: 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.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00652977

Locations
Sweden
Helsingborgs lasarett
Helsingborg, Sweden, 25187
Lund Univeristy Hospital
Lund, Sweden, 221 85
Sponsors and Collaborators
Lund University Hospital
Investigators
Principal Investigator: Andreas Herbst, MD, PhD Lund University Hospital
  More Information

No publications provided by Lund University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andreas Herbst, associate professor, Department of Obstetrics and Gynecology, Lund University Hospital
ClinicalTrials.gov Identifier: NCT00652977     History of Changes
Other Study ID Numbers: Lu1-99
Study First Received: April 1, 2008
Last Updated: April 4, 2008
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Lund University Hospital:
sphincter tears
Ritgen maneuver
perineal tears
prevention
delivery

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries

ClinicalTrials.gov processed this record on August 26, 2014