Open-glottis Pushing Technique Versus the Valsalva Pushing Technique in the Second Stage of Labor

NCT ID: NCT06210087

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Evidence-Based Practice Labor; Prolonged, Second Stage Labor Fetal Acidosis Complicating Labor and Delivery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Spontaneous pushing-Experimental Group Valsalva-type pushing-Control Group
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Spontaneous pushing technique

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ataturk University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ayla Kanbur

Principal Investigator (Assoc. Dr.)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ayla Kanbur, PhD

Role: STUDY_DIRECTOR

Ataturk University

Özlem Koç, PhD

Role: PRINCIPAL_INVESTIGATOR

Tarsus University

Sibel EJDER TEKGÜNDÜZ, Dr.

Role: STUDY_CHAIR

University of Health Science, Faculty of Medicine, Erzurum City Hospital

Özlem Selime MERTER, PhD

Role: STUDY_CHAIR

Firat University

Serap EJDER APAY

Role: STUDY_DIRECTOR

Ataturk University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fırat University

Elâzığ, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VALSPONPUSH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Management of the Third Stage of Labor
NCT02319707 UNKNOWN PHASE3