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
1 other identifier
interventional
162
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedFirst Submitted
Initial submission to the registry
December 22, 2023
CompletedFirst Posted
Study publicly available on registry
January 18, 2024
CompletedJanuary 18, 2024
January 1, 2024
5 months
December 22, 2023
January 6, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Visual Analogue Scale (VAS)
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
questionnaire-Postpartum Interview Form
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
blood samples-Examination of blood samples in the laboratory
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
Study Arms (2)
Spontaneous pushing
EXPERIMENTALThe 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.
Valsalva-type pushing
NO INTERVENTIONRoutine procedures of the delivery room were performed on the pregnant women in the control group, and the researcher carried out no intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- High-risk pregnancy, developing complications during labor, and having a diagnosed psychiatric disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fırat University
Elâzığ, 23119, Turkey (Türkiye)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator (Assoc. Dr.)
Study Record Dates
First Submitted
December 22, 2023
First Posted
January 18, 2024
Study Start
November 1, 2021
Primary Completion
March 31, 2022
Study Completion
May 30, 2022
Last Updated
January 18, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- starting 6 months after publication
individual participant data that underlie results in a publication