Evidence-Based PracticeNCT06210087
Open-glottis Pushing Technique Versus the Valsalva Pushing Technique in the Second Stage of Labor
A study testing Spontaneous pushing technique in people with Evidence-Based Practice and Labor; Prolonged, Second Stage, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Evidence-Based Practice, Labor; Prolonged, Second Stage, Labor
- What is being tested?
- Spontaneous pushing technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- High-risk pregnancy, developing complications during labor, and having a diagnosed psychiatric disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Evidence-Based Practice, Labor; Prolonged, Second Stage, Labor, Fetal Acidosis Complicating Labor and Delivery
- Being tested
- Spontaneous pushing technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spontaneous pushing techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous pushing | Experimental | 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. Receives: Other: Spontaneous pushing technique |
| Valsalva-type pushing | No intervention | Routine procedures of the delivery room were performed on the pregnant women in the control group, and the researcher carried out no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: During the data collection period of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Nov 2021
- Primary completion31 Mar 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evidence-Based PracticeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Spontaneous pushing-Experimental Group Valsalva-type pushing-Control Group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayla Kanbur, Ataturk University
- Investigators
- Ayla Kanbur, PhD, Study director, Ataturk UniversityÖzlem Koç, PhD, Principal investigator, Tarsus UniversitySibel EJDER TEKGÜNDÜZ, Dr., Study chair, University of Health Science, Faculty of Medicine, Erzurum City HospitalÖzlem Selime MERTER, PhD, Study chair, Firat UniversitySerap EJDER APAY, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210087
- Sponsor's protocol ID
- VALSPONPUSH
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06210087
- Acronym / sponsor ID
- VALSPONPUSH
- Conditions
- Evidence-Based Practice, Labor; Prolonged, Second Stage, Labor, Fetal Acidosis Complicating Labor and Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Spontaneous pushing-Experimental Group Valsalva-type pushing-Control Group
| Arm | Type | Receives |
|---|---|---|
| Spontaneous pushing | Experimental | Other: Spontaneous pushing techniqueThe 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 intervention | –Routine procedures of the delivery room were performed on the pregnant women in the control group, and the researcher carried out no intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- High-risk pregnancy, developing complications during labor, and having a diagnosed psychiatric disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spontaneous pushing techniquePregnant 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. | Other | Spontaneous pushing |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: During the data collection period of 7 months
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.
questionnaire-Postpartum Interview Form
Time frame: During the data collection period of 7 months
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.
blood samples-Examination of blood samples in the laboratory
Time frame: During the data collection period of 7 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Yes. individual participant data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayla Kanbur, PhD study director
Ataturk University
Özlem Koç, PhD principal investigator
Tarsus University
Sibel EJDER TEKGÜNDÜZ, Dr. study chair
University of Health Science, Faculty of Medicine, Erzurum City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spontaneous pushing technique in people with Evidence-Based Practice and Labor; Prolonged, Second Stage, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: During the data collection period of 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.