Ritgen Maneuver and Birth-Related Perineal Trauma: RCT

NCT07713173 | Completed

• 1 other identifier: E-10840098-202.3.02-3487
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Perineal trauma is one of the common complications that may occur during the second stage of labor and can negatively affect women's postpartum recovery and quality of life. The Ritgen maneuver is a hands-on perineal protection technique performed during fetal head delivery to control the birth of the fetal head and potentially reduce perineal injury. However, evidence regarding its effectiveness remains inconsistent. This randomized controlled trial aims to evaluate the effect of the Ritgen maneuver on perineal trauma during the second stage of labor. Pregnant women admitted for vaginal birth will be randomly assigned to either the Ritgen maneuver group or the standard care group. The incidence and degree of perineal trauma, episiotomy, and related maternal outcomes will be compared between groups. The findings of this study are expected to contribute to the evidence base regarding perineal protection techniques during vaginal birth and support the development of clinical practices aimed at reducing birth-related perineal trauma

Conditions

Perineal Trauma; Ritgen Maneuver

Keywords

ritgen maneuver; perineal trauma

Outcome Measures

Primary Outcomes (1)

• Incidence of Perineal Trauma

  The occurrence of any perineal trauma following vaginal birth, including spontaneous perineal lacerations and episiotomy-related perineal injury.

  Immediately after birth

Secondary Outcomes (1)

• Postpartum Pain Score

  Within 2 hours after birth

Study Arms (2)

Ritgen Maneuver Group

EXPERIMENTAL

Participants in this group received the Ritgen maneuver during the second stage of labor. The maneuver was applied during delivery of the fetal head with the aim of protecting the perineum and reducing perineal trauma. Perineal outcomes were assessed following birth

Other: Ritgen maneuver

Routine Care Group

OTHER

Participants in this group received routine intrapartum care during the second stage of labor according to institutional practice without application of the Ritgen maneuver. Perineal outcomes were assessed following birth.

Other: Routine Care Group

Interventions

Ritgen maneuver OTHER

The Ritgen maneuver was performed during crowning and delivery of the fetal head. One hand was used to control the fetal head while the other supported the perineum to facilitate controlled birth and potentially reduce perineal injury

Ritgen Maneuver Group

Routine Care Group OTHER

Standard management of the second stage of labor according to institutional practice without application of the Ritgen maneuver.

Routine Care Group

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women aged 20 years or older.
• Gestational age ≥37 weeks.
• Singleton pregnancy.
• Cephalic (vertex) presentation.
• Planned vaginal birth.
• No perineal massage during the last 4 weeks of pregnancy.
• Not regularly engaged in active sports activity.
• Willing to participate and provide informed consent

You may not qualify if:

• Fetal anomaly.
• Human papillomavirus (HPV) infection.
• Herpes simplex virus (HSV) infection.
• Presence of perineal edema.
• Vulvar varicosities.
• Opioid administration during labor.
• Prolonged labor.
• Labor dystocia.
• Development of fetal distress during labor.
• Instrumental vaginal delivery (vacuum, Kiwi, or forceps-assisted delivery)

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Esenler Maternity and Pediatric Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• Ahmadi Z, Torkzahrani S, Roosta F, Shakeri N, Mhmoodi Z. Effect of Breathing Technique of Blowing on the Extent of Damage to the Perineum at the Moment of Delivery: A Randomized Clinical Trial. Iran J Nurs Midwifery Res. 2017 Jan-Feb;22(1):62-66. doi: 10.4103/1735-9066.202071.

  PMID: 28382061 BACKGROUND

• Albers LL, Sedler KD, Bedrick EJ, Teaf D, Peralta P. Midwifery care measures in the second stage of labor and reduction of genital tract trauma at birth: a randomized trial. J Midwifery Womens Health. 2005 Sep-Oct;50(5):365-72. doi: 10.1016/j.jmwh.2005.05.012.

  PMID: 16154062 BACKGROUND

Study Officials

• Gozde Kugcumen

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Ph.D.

Model Details: Participants were randomly assigned to either a Ritgen maneuver group or a control group receiving routine care during the second stage of labor. Perineal trauma outcomes were compared between groups.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 20, 2026
• Study Start: September 9, 2025
• Primary Completion: May 26, 2026
• Study Completion: May 26, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)