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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06210087
Other study ID # VALSPONPUSH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date May 30, 2022

Study information

Verified date January 2024
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 162
Est. completion date May 30, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

Other:
Spontaneous pushing technique
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.

Locations

Country Name City State
Turkey Firat University Elazig

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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