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

NCT ID: NCT00652977

Last Updated: 2008-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1623 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2001-07-31

Brief Summary

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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

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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

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Perineal Lacerations

Keywords

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sphincter tears Ritgen maneuver perineal tears prevention delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ritgens maneuver

Intervention Type PROCEDURE

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

Group Type OTHER

Standard care (Manual support of the perineum)

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lund University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Obstetrics and Gynecology, Lund University Hospital

Principal Investigators

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Andreas Herbst, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University Hospital

Locations

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Helsingborgs lasarett

Helsingborg, , Sweden

Site Status

Lund Univeristy Hospital

Lund, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 18669713 (View on PubMed)

Other Identifiers

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Lu1-99

Identifier Type: -

Identifier Source: org_study_id