Clinical trial NCT06210087: Open-glottis Pushing Technique Versus the Valsalva Pushing Technique in the Second Stage of Labor
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evidence-Based Practice
Labor; Prolonged, Second Stage
Labor
Fetal Acidosis Complicating Labor and Delivery
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Spontaneous pushing-Experimental Group Valsalva-type pushing-Control Group
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: During the data collection period of 7 months
measure: questionnaire-Postpartum Interview Form
timeFrame: During the data collection period of 7 months
measure: blood samples-Examination of blood samples in the laboratory
timeFrame: During the data collection period of 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Fırat University
Study officials:
affiliation: Ataturk University
name: Ayla Kanbur, PhD
role: STUDY_DIRECTOR
affiliation: Tarsus University
name: Özlem Koç, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Health Science, Faculty of Medicine, Erzurum City Hospital
name: Sibel EJDER TEKGÜNDÜZ, Dr.
role: STUDY_CHAIR
affiliation: Firat University
name: Özlem Selime MERTER, PhD
role: STUDY_CHAIR
affiliation: Ataturk University
name: Serap EJDER APAY
role: STUDY_DIRECTOR
References: