- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06210087
Open-glottis Pushing Technique Versus the Valsalva Pushing Technique in the Second Stage of Labor
The Effect of the Open-glottis (Spontaneous) Pushing Technique Versus the Closed-glottis (Valsalva) Pushing Technique in the Second Stage of Labor on Fetal Acid-base Level and Maternal Outcomes: a Randomized Controlled Trial
Pushing has been discussed for decades, primarily in terms of facilitating care in the second stage of labor and maternal/fetal outcomes.
Valsalva-type pushing is the pushing performed by a pregnant woman by holding her breath. Various physiological findings argue against the Valsalva maneuver may adversely affect the acid-base balance and cerebral oxygenation of the fetus. It has been shown that a long apnea period (long closed glottis) associated with the Valsalva maneuver during the expulsive stage of labor increases lactate concentration in the mother and the fetus and adversely affects the fetal acid-base balance.
Spontaneous pushing is the pushing movements that occur naturally in the second stage of birth. Spontaneous pushing is part of the natural birth process and encourages women to trust the natural functioning of their bodies. When pushing with an open glottis, fetal placental circulation is preserved since the pressure on the chest does not increase and there are fewer hemodynamic effects.
The World Health Organization (WHO) recommends that women in the second stage of labor should be encouraged and supported to follow their pushing urges. The WHO states that healthcare professionals involved in obstetric care should avoid the Valsalva maneuver due to the lack of evidence that this technique has any benefit in the second stage of labor. The WHO supports spontaneous pushing in its recommendations for a positive birth experience. Safe termination of labor for both the mother and fetus is one of the primary duties of all healthcare professionals. There are few studies examining the maternal and fetal effects of the pushing types used during labor, especially their effects on the acid-base balance in the fetus. To contribute to the quality of evidence on the subject, the effects of Valsalva-type and spontaneous pushing techniques in the second stage of labor on fetal acid-base level and maternal outcomes were examined.
Hypotheses of the Research H1: Spontaneous pushing reduces the mother's pain level. H2: Spontaneous pushing increases the mother's birth satisfaction. H3: Spontaneous pushing positively affects the acid-base balance of the fetus. H4: Valsalva-type pushing increases the mother's pain level. H5: Valsalva-type pushing reduces the mother's birth satisfaction. H6: Valsalva-type pushing negatively affects the acid-base balance of the fetus.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Elazığ, Turkey, 23119
- Fırat university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Being at least a primary school graduate, being between the 38th and 42nd weeks of gestation, having a single fetus in a vertex position, giving vaginal birth, not developing any complications during labor, and volunteering to participate in the study.
Exclusion Criteria:
High-risk pregnancy, developing complications during labor, and having a diagnosed psychiatric disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Spontaneous pushing
The researcher provided training on the spontaneous pushing technique to the pregnant women selected for the experimental group in the first stage of labor and showed how to do it.
During the second stage of labor, the women were encouraged and supported in this direction.
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Pregnant women selected for the experimental group were trained on spontaneous pushing technique in the first stage of labor.
During the second stage of labor, the women were encouraged and supported in this direction.
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No Intervention: Valsalva-type pushing
Routine procedures of the delivery room were performed on the pregnant women in the control group, and the researcher carried out no intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: During the data collection period of 7 months
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for labor pain level Visual Analogue Scale (VAS): It is used to measure the intensity of pain in the patient. The VAS is a measurement tool that is frequently and safely used to evaluate labor pain. The VAS is 10 cm long. Women were asked to score pain from zero to 10. A zero score means no pain, while 10 means the most severe pain experienced. Pain level was evaluated with the VAS in the 2nd Stage of Labor. |
During the data collection period of 7 months
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questionnaire-Postpartum Interview Form
Time Frame: During the data collection period of 7 months
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for mother's birth satisfaction Postpartum Interview Form: It is a form consisting of questions that include women's opinions about the pushing type applied during labor. The postpartum interview form was applied to women in the experimental and control groups during the fourth stage of labor. |
During the data collection period of 7 months
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blood samples-Examination of blood samples in the laboratory
Time Frame: During the data collection period of 7 months
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acid-base balance of the fetus In the experimental and control groups, after the umbilical cord was clamped in the third stage of birth, 1 cc blood samples were taken from the umbilical blood. Blood samples for fetal acid base measurement were taken in the 3rd stage of labor. |
During the data collection period of 7 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ayla Kanbur, PhD, Ataturk University
- Principal Investigator: Özlem Koç, PhD, Tarsus University
- Study Chair: Sibel EJDER TEKGÜNDÜZ, Dr., University of Health Science, Faculty of Medicine, Erzurum City Hospital
- Study Chair: Özlem Selime MERTER, PhD, Firat University
- Study Director: Serap EJDER APAY, Ataturk 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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VALSPONPUSH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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