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Simple hand technique during birth may cut perineal tears

NCT ID NCT07713173

Disease control Sponsor: Medipol University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
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Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This trial investigates whether the Ritgen maneuver, a hands-on technique used during the delivery of the baby's head, can reduce perineal trauma compared to standard care. The study includes pregnant women planning a vaginal birth at full term. Researchers will compare the rate and severity of perineal tears and episiotomies between the two groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ritgen maneuver (a hands-on perineal protection technique performed during fetal head delivery)
What this could lead to
If effective, this technique could become a standard practice to reduce birth-related perineal injuries and improve postpartum recovery.
What could go wrong
This is a relatively small trial, and previous evidence on the Ritgen maneuver has been inconsistent, so results may not be conclusive or widely applicable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

122 people

The number who actually took part.

Started

Sep 2025

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Perineal trauma Ritgen maneuver

Contacts and locations

Locations

  • Esenler Maternity and Pediatric Hospital

    Istanbul, Turkey (Türkiye)

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