The Effect of Straining Techniques on Women and Newborn

Newborn; Vitality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05578794
• Other study ID #: OAkgun
• Status: Completed
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: October 2022
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: November 30, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 41 Years

Eligibility

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

Related Conditions & MeSH terms

• Newborn; Vitality
• Prolonged Second Stage of Labor
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Turkey	Sivas sample hospital	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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

External Links

•   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.
•   Second Stage of Labor
•   The impact of valsalva's versus spontaneous pushing techniques during second stage of labor on postpartum maternal fatigue and neonatal outcome.