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Completed

NCT Number: NCT05578794

The Effect of Straining Techniques on Women and Newborn

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.

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Key information

Conditions

Prolonged Second Stage of Labor Newborn; Vitality Other Specified Trauma to Perineum and Vulva During Delivery

Age range

19 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sivas sample hospital

Sivas, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Straining types

Other

Valsalva, spontaneous and natural strainings are supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.

Primary outcomes

  1. The distribution of the duration of the second phase according to the straining styles of women in labor

    Time frame: 2-90 minute

    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. The perineal trauma status according to the straining styles of women during labor

    Time frame: 10-30 minute

    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.

  3. The distribution of the mean Apgar Scores of the newborns according to the straining types of women during labor

    Time frame: 1-5 minute

    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).

Secondary outcomes

  1. The distribution of women's satisfaction and considerations about the practice according to the way they strain during labor

    Time frame: 30 minute- 4 hours

    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.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 13, 2022
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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