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
Who can participate
Age range
20 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.