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

NCT00652977 | Completed

• 1 other identifier: Lu1-99
• Study Type: interventional
• Target: 1,623
• Locations: 1 country
• Sites: 2

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.

Conditions

Perineal Lacerations

Keywords

sphincter tears; Ritgen maneuver; perineal tears; prevention; delivery

Outcome Measures

Primary Outcomes (1)

• Perineal rupture grade III-IV (anal sphincter tears)

  At delivery - within minutes - hours of randomization

Study Arms (2)

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.

Procedure: Ritgens maneuver

II

OTHER

Standard care at delivery: Manual support of the perineum

Procedure: Standard care (Manual support of the perineum)

Interventions

Ritgens maneuver 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

I

Standard care (Manual support of the perineum) 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.

II

Eligibility Criteria

• Age: 16 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Operative delivery

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (2)

Helsingborgs lasarett

Helsingborg, 25187, Sweden

Location

Lund Univeristy Hospital

Lund, 221 85, Sweden

Location

Related Publications (1)

• 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.

  PMID: 18669713 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Andreas Herbst, MD, PhD

  Lund University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: December 1, 1999
• Primary Completion: July 1, 2001
• Study Completion: July 1, 2001
• Last Updated: April 7, 2008

Record last verified: 2008-04

Locations

SE (2)