NCT06210087

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

December 22, 2023

Last Update Submit

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

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.

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.

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.

Spontaneous pushing

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Location

Study Officials

  • Ayla Kanbur, PhD

    Ataturk University

    STUDY DIRECTOR
  • Özlem Koç, PhD

    Tarsus University

    PRINCIPAL INVESTIGATOR
  • Sibel EJDER TEKGÜNDÜZ, Dr.

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

    STUDY CHAIR
  • Özlem Selime MERTER, PhD

    Firat University

    STUDY CHAIR
  • Serap EJDER APAY

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Spontaneous pushing-Experimental Group Valsalva-type pushing-Control Group
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

individual participant data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
starting 6 months after publication

Locations