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NCT Number: NCT07713173

Ritgen Maneuver and Birth-Related Perineal Trauma: RCT

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

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Key information

Conditions

Perineal Trauma Ritgen Maneuver

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Esenler Maternity and Pediatric Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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

routine care group

Other

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

Primary outcomes

  1. Incidence of Perineal Trauma

    Time frame: Immediately after birth

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

Secondary outcomes

  1. Postpartum Pain Score

    Time frame: Within 2 hours after birth

    Maternal postpartum pain assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain)

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

The Effect of the Ritgen Maneuver on Perineal Trauma During the Second Stage of Labor: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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