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The Effect of Straining Techniques on Women and Newborn

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Straining types
Sponsored by
Cumhuriyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prolonged Second Stage of Labor focused on measuring Labor, Midwife, Pregnant, Straining techniques, Perineal trauma, Apgar Score

Eligibility Criteria

19 Years - 41 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Sivas sample hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Valsalva Straining (Control Group)

Spontaneous Straining

Natural Straining

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

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.

Full Information

First Posted
October 5, 2022
Last Updated
October 11, 2022
Sponsor
Cumhuriyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05578794
Brief Title
The Effect of Straining Techniques on Women and Newborn
Official Title
The Effect of Straining Techniques on Duration of Labor, Perineal Trauma Status, and Newborn Apgar Score
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cumhuriyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolonged Second Stage of Labor, Other Specified Trauma to Perineum and Vulva During Delivery, Newborn; Vitality
Keywords
Labor, Midwife, Pregnant, Straining techniques, Perineal trauma, Apgar Score

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Valsalva-type Straining (Group I), Spontaneous Straining (Group II), Natural Straining (Group III))
Masking
None (Open Label)
Allocation
Randomized
Enrollment
354 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valsalva Straining (Control Group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Spontaneous Straining
Arm Type
Experimental
Arm Description
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.
Arm Title
Natural Straining
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Straining types
Intervention Description
Valsalva, spontaneous and natural strainings are supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.
Primary Outcome Measure Information:
Title
The distribution of the duration of the second phase according to the straining styles of women in labor
Description
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.
Time Frame
2-90 minute
Title
The perineal trauma status according to the straining styles of women during labor
Description
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.
Time Frame
10-30 minute
Title
The distribution of the mean Apgar Scores of the newborns according to the straining types of women during labor
Description
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).
Time Frame
1-5 minute
Secondary Outcome Measure Information:
Title
The distribution of women's satisfaction and considerations about the practice according to the way they strain during labor
Description
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.
Time Frame
30 minute- 4 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulbahtiyar Demirel
Organizational Affiliation
Cumhuriyet University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sivas sample hospital
City
Sivas
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://doi.org/10.1097/GRF.0000000000000113
Description
Second Stage of Labor
URL
http://doi.org/10.1016/j.midw.2020.102843
Description
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.
URL
http://www.sjmms.net/text.asp?2014/2/2/101/137000
Description
The impact of valsalva's versus spontaneous pushing techniques during second stage of labor on postpartum maternal fatigue and neonatal outcome.

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The Effect of Straining Techniques on Women and Newborn

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