- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07537842
Comparison of Finnish and Viennese Techniques for Perineal Protection in Women During the Second Stage of Labor
Comparison of Finnish Versus Viennese Technique for Manual Perineal Protection in the 2nd Stage of Labor
The goal of this clinical trial is to find out which method of protecting the perineum during childbirth works better in reducing tears in first-time mothers. The study will compare two commonly used techniques-Finnish and Viennese manual perineal protection-during the second stage of labor. It will also assess whether these techniques are safe and practical to use.
The main questions it aims to answer are:
- Does the Finnish technique reduce the number of perineal tears compared to the Viennese technique?
- Are there any differences in labor outcomes or complications between the two techniques?
Researchers will randomly assign 60 pregnant women (first-time mothers with full-term, single pregnancies) into two groups. One group will receive the Finnish technique, while the other group will receive the Viennese technique during the second stage of labor.
Participants will:
- Be enrolled when they are in active labor and planning a normal vaginal delivery
- Be randomly assigned to one of the two perineal protection techniques
- Have their labor monitored, including the duration of different stages of labor
- Undergo a clinical examination after delivery to check for any perineal tears
A trained obstetrician who is not aware of which technique was used will examine the mother after delivery to ensure unbiased assessment. Any tears identified will be treated according to standard hospital guidelines.
By comparing these two techniques, this study aims to identify the safer and more effective method to reduce perineal injury during childbirth, which may help improve maternal outcomes and quality of care.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Multan, Punjab Province, Pakistan, 60000
- Nishtar Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Full-term (37 - 42 weeks, assessed through LMP)
- Singleton pregnancy (assessed on antenatal scan)
- Primigravida
- In active labor
Exclusion Criteria:
- Fetal presentation other than cephalic (confirmed on USG)
- Patients converted to cesarean delivery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Finnish Manual Perineal Protection
Participants in this group will receive manual perineal protection using the Finnish technique during the second stage of labor.
|
This involves applying pressure with the flexed middle, ring, and little fingers to support the perineum and control delivery of the fetal head.
This would reduce perineal stretching and tearing during delivery.
|
|
Active Comparator: Viennese Manual Perineal Protection
Participants in this group will receive manual perineal protection using the Viennese technique during the second stage of labor.
|
This technique includes applying ventral pressure with the ulnar part of the palm while supporting the perineum and controlling fetal head extension at crowning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perineal Tear
Time Frame: Immediately after delivery (within the third stage of labor)
|
Perineal tear will be assessed by clinical examination after delivery.
It is defined as any laceration involving the perineal skin, vaginal mucosa, perineal muscles, anal sphincter, or rectal mucosa.
The presence or absence of a tear will be recorded.
|
Immediately after delivery (within the third stage of labor)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of First Stage of Labor
Time Frame: During labor (from onset of active labor to full cervical dilation)
|
The first stage of labor is defined as the time from active labor (cervical dilation of 3-4 cm) to full cervical dilation (10 cm).
Duration will be recorded in minutes.
|
During labor (from onset of active labor to full cervical dilation)
|
|
Duration of Second Stage of Labor
Time Frame: During labor (from full dilation to delivery)
|
The second stage of labor is defined as the time from full cervical dilation to delivery of the baby.
Duration will be recorded in minutes.
|
During labor (from full dilation to delivery)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Syeda A Professor, FCPS, Nishtar Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- U1111-1338-9045
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vaginal Delivery
-
Cairo UniversityCompleted
-
Ain Shams Maternity HospitalRecruiting
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Assiut UniversityNot yet recruiting
-
Cairo UniversityUnknownVaginal DeliveryEgypt
-
Faculty Hospital Kralovske VinohradyCompletedPotential of Vojta's Reflex Locomotion as a Pre/Induction Method for Uterine Activity: a Pilot StudyInduced Vaginal DeliveryCzechia
-
Sohag UniversityNot yet recruitingVaginal Delivery
-
Second Affiliated Hospital of Wenzhou Medical UniversityNot yet recruiting
-
Cairo UniversityCompletedVaginal DeliveryEgypt
Clinical Trials on Finnish Manual Perineal Protection Technique
-
Istinye UniversityCompletedPerineal Tear | Labor Complication | Episiotomy Extended by LacerationTurkey
-
Knut HaademUnknown
-
Karolinska InstitutetDanderyd HospitalEnrolling by invitationPerineal Laceration, Tear, or Rupture During DeliverySweden
-
Namik Kemal UniversityCompleted
-
Tribhuvan University, NepalCompletedPain | Labor | Perineal Tear | Heat TherapyNepal
-
Hacettepe UniversityCompleted
-
Universidad de LeónCompletedObstetric Labor Complications | Primary Prevention | Musculoskeletal Manipulations | Physical Therapy ModalitiesSpain
-
Helsingborgs HospitalSkane University Hospital; Lund University HospitalCompleted
-
University of AarhusAarhus University Hospital; Danish Research Agency; Aase and Ejnar Danielsens... and other collaboratorsCompletedEpisiotomy | Perineal LacerationsDenmark
-
Helga Cecília Muniz de SouzaUniversidade Federal de PernambucoCompleted