Prolonged Second Stage of LaborNCT05578794
The Effect of Straining Techniques on Women and Newborn
A study testing Straining types in people with Prolonged Second Stage of Labor and Other Specified Trauma to Perineum and Vulva During Delivery, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 19 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolonged Second Stage of Labor, Other Specified Trauma to Perineum and Vulva During Delivery, Newborn; Vitality
- What is being tested?
- Straining types
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prolonged Second Stage of Labor, Other Specified Trauma to Perineum and Vulva During Delivery, Newborn; Vitality
- Being tested
- Straining types
- Keywords
- Labor, Midwife, Pregnant, Straining techniques, Perineal trauma, Apgar Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straining typesOther
Valsalva, spontaneous and natural strainings are supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Valsalva Straining (Control Group) | Experimental | 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. Receives: Other: Straining types |
| Spontaneous Straining | Experimental | 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. Receives: Other: Straining types |
| Natural Straining | Experimental | 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. Receives: Other: Straining types |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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).
Measured: 1-5 minute
Secondary outcomes (1)
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.
Measured: 30 minute- 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start24 Feb 2020
- Primary completion15 Mar 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Second Stage of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Valsalva-type Straining (Group I), Spontaneous Straining (Group II), Natural Straining (Group III))
- Masking
- None (open label)
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Akgün, Cumhuriyet University
- Investigators
- Gulbahtiyar Demirel, Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578794
- Sponsor's protocol ID
- OAkgun
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Straining Techniques on Duration of Labor, Perineal Trauma Status, and Newborn Apgar Score
- ClinicalTrials.gov ID
- NCT05578794
- Acronym / sponsor ID
- OAkgun
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Valsalva-type Straining (Group I), Spontaneous Straining (Group II), Natural Straining (Group III))
| Arm | Type | Receives |
|---|---|---|
| Valsalva Straining (Control Group) | Experimental | Other: Straining typesThe 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. |
| Spontaneous Straining | Experimental | Other: Straining typesThe 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. |
| Natural Straining | Experimental | Other: Straining typesThe 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. |
Who may qualify
- Ages
- 19 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Straining typesValsalva, spontaneous and natural strainings are supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated. | Other | Natural Straining, Spontaneous Straining, Valsalva Straining (Control Group) |
Primary outcome
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.
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.
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Second Stage of LaborLink provided by the sponsor.
- 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.Link provided by the sponsor.
- The impact of valsalva's versus spontaneous pushing techniques during second stage of labor on postpartum maternal fatigue and neonatal outcome.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Prolonged Second Stage of Labor
Recruiting
Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery
Prolonged Second Stage of Labor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulbahtiyar Demirel principal investigator
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Straining types in people with Prolonged Second Stage of Labor and Other Specified Trauma to Perineum and Vulva During Delivery, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distribution of the duration of the second phase according to the straining styles of women in labor (time frame: 2-90 minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.