The Effect of Straining Techniques on Women and Newborn

The Effect of Straining Techniques on Duration of Labor, Perineal Trauma Status, and Newborn Apgar Score

Purpose: To examine the effects of straining techniques on the duration of labor, perineal trauma status and newborn apgar score.

Method: This study is a randomized controlled trial. The straining techniques were explained to the pregnant women who gave written consent to participate in the study and were randomly assigned to groups in the latent phase (natural, spontaneous, Valsalva), and the techniques were applied in the second phase of labor.

Study Overview

• Status: Completed
• Conditions: Newborn; Vitality; Prolonged Second Stage of Labor; Other Specified Trauma to Perineum and Vulva During Delivery
• Intervention / Treatment: Other: Straining types

Detailed Description

Purpose: The present study was planned to determine the effects of straining techniques on the duration of labor, perineal trauma status, and newborn Apgar score.

Method: The study, which had a randomized-controlled experimental design, was conducted in Sivas Numune Hospital Birth Unit. The sampling size was calculated using power analysis. In the literature, spontaneous straining is used by pregnant women in the range of 25-81%, and Valsalva -type straining has a rate of 32-75%. To represent the population of the study, sample volume was determined at =0.05 significance level, 1- =0.95 Confidence Interval, =0.20 error risk, and 1- =0.80 power, and the total number of individuals was determined as 354. The data of the study were collected with the "Pre-Evaluation Form", "Personal Information Form", "Labor Evaluation Form", and "Apgar Score" created by the researchers in line with the literature data. The straining techniques were explained to the pregnant women who gave written consent to participate in the study and were randomly assigned to groups in the latent phase (natural, spontaneous, Valsalva), and the techniques were applied in the second phase of labor. ANOVA, Kruskal Wallis H-test, Chi-square test, Exact test, Tamhane T2 test, and Dunn Test were used to evaluate the data obtained in the study. Statistical significance was evaluated at a 0.05 significance level and the SPSS version 23.0 was used.

• Study Type: Interventional
• Enrollment (Actual): 354
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sivas, Turkey
    • Sivas sample hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 38-42. being at the gestational week,
• Having a singleton pregnancy
• Fetus in vertex position
• Being in the latent phase in the first stage of labor
• Planning and having a normal vaginal birth,
• Not having a diagnosed chronic physical disease,
• Not having a diagnosed psychiatric disease,
• No risk of risky pregnancy or fetal anomaly,
• Being literate,
• No communication problem
• Giving birth in the lithotomy position
• Volunteering to participate in the study

Exclusion Criteria:

• 38-42. not in the week of pregnancy,
• Having multiple pregnancy
• Fetus out of vertex position
• Being in the latent phase in the first stage of birth,
• Having a cesarean section while planning a normal vaginal delivery,
• Having a diagnosed chronic physical illness,
• Having a diagnosed psychiatric illness,
• Having a risky pregnancy or fetal anomaly risk,
• illiteracy,
• Having a communication problem
• Giving birth in different positions
• Not willing to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Valsalva Straining (Control Group); The straining techniques for the groups were explained by the researcher in line with the process steps in the latent phase. Valsalva straining is supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.	Other: Straining types; Valsalva, spontaneous and natural strainings are supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.
Experimental: Spontaneous Straining; The straining techniques for the groups were explained by the researcher in line with the process steps in the latent phase. Spontaneous straining is supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.	Other: Straining types; Valsalva, spontaneous and natural strainings are supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.
Experimental: Natural Straining; The straining techniques for the groups were explained by the researcher in line with the process steps in the latent phase. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.	Other: Straining types; Valsalva, spontaneous and natural strainings are supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The distribution of the duration of the second phase according to the straining styles of women in labor	The distribution of the duration of the second phase was evaluated according to the pushing styles of the women who gave birth. The duration of the second stage of labor was calculated by keeping the hours and minutes according to the type of straining used. The time from the woman's full dilation (10 cm) to the birth of the baby was measured.	2-90 minute
The perineal trauma status according to the straining styles of women during labor	Perineal trauma status of women was evaluated according to their pushing styles during delivery. Episiotomy or laceration status after delivery of the placenta was evaluated by observation and examination method.	10-30 minute
The distribution of the mean Apgar Scores of the newborns according to the straining types of women during labor	The newborn apgar scores were evaluated according to the straining types of the women at the time of delivery. Apgar Score is the expression of the physiological condition of the infant at a certain time (ACOG, 2015). In studies examining the relationship between mortality rates and Apgar scores, it was shown that infants with low scores (0-2) had higher mortality rates (14%). Infants with high scores (7-10) had lower mortality rates (0.13%). The scoring system showed that overall Apgar scores of infants born with cesarean section were lower than those born vaginally (Apgar, 1966; Rubarth, 2012). Apgar developed this evaluation tool with 5 objective criteria (heart rate, respiration, reflex irritability, muscle tonus, and color). The Apgar Evaluation System is used in the 1st and 5th minutes after the infant is born. Apgar scores of 7-10 are reassuring, normal, 4-6 moderately abnormal, and 0-3 are considered low in term and preterm infants (ACOG, 2015).	1-5 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The distribution of women's satisfaction and considerations about the practice according to the way they strain during labor	According to the types of straining during childbirth, women's satisfaction and thoughts about the application were evaluated. The satisfaction of women with the pushing techniques was evaluated with the questions asked in the questionnaire. Each woman was asked whether she would like to use the type of pushing she used in her next birth.	30 minute- 4 hours

Collaborators and Investigators

• Sponsor: Cumhuriyet University
• Investigators: Principal Investigator: Gulbahtiyar Demirel, Cumhuriyet University

Publications and helpful links

Helpful Links

• Second Stage of Labor
• Is directed open-glottis pushing more effective than directed closed-glottis pushing during the second stage of labor? A pragmatic randomized trial-the EOLE study.
• The impact of valsalva's versus spontaneous pushing techniques during second stage of labor on postpartum maternal fatigue and neonatal outcome.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Labor; Apgar Score; Midwife; Pregnant; Perineal trauma; Straining techniques
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: OAkgun

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No