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

Primary Purpose

Perineal Lacerations

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Ritgens maneuver
Standard care (Manual support of the perineum)
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perineal Lacerations focused on measuring sphincter tears, Ritgen maneuver, perineal tears, prevention, delivery

Eligibility Criteria

16 Years - 44 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Helsingborgs lasarett
  • Lund Univeristy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

I

II

Arm Description

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.

Standard care at delivery: Manual support of the perineum

Outcomes

Primary Outcome Measures

Perineal rupture grade III-IV (anal sphincter tears)

Secondary Outcome Measures

Full Information

First Posted
April 1, 2008
Last Updated
April 4, 2008
Sponsor
Lund University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00652977
Brief Title
Ritgens Maneuver for the Prevention of Anal Sphincter Tears at Delivery: A Randomized Controlled Trial
Official Title
Modified Ritgens Maneuver for Perineal Protection at Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
July 2001 (Actual)
Study Completion Date
July 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lund University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perineal Lacerations
Keywords
sphincter tears, Ritgen maneuver, perineal tears, prevention, delivery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1623 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Active Comparator
Arm Description
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.
Arm Title
II
Arm Type
Other
Arm Description
Standard care at delivery: Manual support of the perineum
Intervention Type
Procedure
Intervention Name(s)
Ritgens maneuver
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Standard care (Manual support of the perineum)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perineal rupture grade III-IV (anal sphincter tears)
Time Frame
At delivery - within minutes - hours of randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Herbst, MD, PhD
Organizational Affiliation
Lund University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsingborgs lasarett
City
Helsingborg
ZIP/Postal Code
25187
Country
Sweden
Facility Name
Lund Univeristy Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
18669713
Citation
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.
Results Reference
derived

Learn more about this trial

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

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