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PreventionNCT04207658

The Effects Of Pushing Techniques During Second Stage Of Labour On Maternal and Newborn Health

A study testing Valsalva's Style Pushing in people with Prevention and Newborn Complication, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose :To determine the impact of directed Valsalva's's versus spontaneous pushing techniques during second stage of labour on postpartum maternal fatigue. . Methods: The control group participants have an onset of spontaneous pushing when the cervical dilatation was 6cm while the directed pushing group carried out… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Prevention, Newborn Complication
What is being tested?
Valsalva's Style Pushing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2017to 20 May 2018
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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women are accepted in the study on condition that they are aged 18 and more
  • Primigravida
  • bearing single foetus between 2500 and 3999gr of birth weight in vertex position
  • in 38-42 gestation weeks
  • they must also accept to participate in the study
  • with a cervical dilatation of 6cm

Who cannot join

  • obstetrical or medical complications during labour,
  • expected to have spontaneous vaginal labour with risk factors

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Evrim Bayraktar

    Kayseri, Melikgazi, 38039

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects Of Pushing Techniques During Second Stage Of Labour

Purpose :To determine the impact of directed Valsalva's's versus spontaneous pushing techniques during second stage of labour on postpartum maternal fatigue. .

Methods: The control group participants have an onset of spontaneous pushing when the cervical dilatation was 6cm while the directed pushing group carried out the Valsalva's manoeuvre.The data of the study are obtained by utilizing Baseline Obstetric Data Form and Visual Analogue Fatigue Scale (VAFS). The investigators have done postpartum tests on perineal tear, hemorrhagia, haemoglobin level, vital findings, blood pH, pO2 and pCO2, and lactate level for the mother while the neonatal tests of APGAR score for 1st and 5th minutes, umbilical artery blood pH, pO2 and pCO2 levels are done for the newborn.

Read the detailed description

Vaginal births are often associated with some form of trauma to the genital tract, and tears that affect the anal sphincter or mucosa (third- and fourth-degree tears) can cause serious problems. Perineal trauma can occur spontaneously or result from a surgical incision (episiotomy). Different perineal techniques are being used to slow down the birth of the baby's head, and allow the perineum to stretch slowly to prevent injury. Massage, warm compresses and different perineal management techniques are widely used by midwives and birth attendants.

A computer program designed by an independent group of the clinical research centre is creating the randomisation list, in blocks of four to six (randomly chosen by the electronic system and well balanced by centre) and stratified by maternity ward and within maternity wards by both parity (nulliparous vs multiparous) and epidural analgesia use at randomisation. The randomisation and the data collection will be performed at a website available 24 hours a day.

After the midwives-investigators have verified the inclusion and exclusion criteria and collected the signed informed consent, the randomisation will take place. There is no conceivable way to conduct this study on either a double-blinded or single-blinded basis.

Sample The population of our study consists of primigravida hospitalized at Erciyes University Training and Research Hospital. In line with data in the literature, the computations are done considering the fulfilment rate of Valsalva's Manoeuvre pushing as 20% and 50% in spontaneous pushing for fewer interventions through wellness of baby and the mother. Thus, sample volumes to represent the population are p1= 0.20 (control group), p2= 0.50 (experimental group), %95 confidence interval, α= 0.05, β = 0.20, power = 0.80 (1-β) for each group n=82 women, and in total 164 mothers.

Criteria of primigravida in the study; Women are accepted in the study on condition that they are aged 18 and more, primigravida, bearing single foetus between 2500 and 3999gr of birth weight in vertex position, in 38-42 gestation weeks, expected to have spontaneous vaginal labour with no or little risk factors, without obstetrical or medical complications during labour, with a cervical dilatation of 6cm and an amnion sack opening at 3cm of cervical dilatation, and they must also accept to participate in the study.

Practices on Spontaneous Pushing Group The gravitas are informed about spontaneous pushing at the active phase of dilatation (6cm) in second stage of labour and they are encouraged for spontaneous pushing just at the onset of pushing. Just after feeling the push, the gravitas are requested perform pushing as follows; Breathe normally until participants feel the push when contractions start, pull back muscles surrounding the uterus while breathing. Start pushing gradually and breathe out smoothly by minimizing lips. Push between breaths for 5-6 seconds while pushing downwards by breathing out. Breathe normally when contractions weaken.

Practices on Valsalva's Style Pushing Group The gravitas are informed about spontaneous pushing at the active phase of dilatation (6cm) in second stage of labour and they are encouraged for spontaneous pushing just at the onset of pushing. At the expulsion phase (baby's head is visible in vulva), they are encouraged to perform the Valsalva's manoeuvre that they have practised in routines of delivery; When contractions start, breathe twice normally. Take a deep breath and hold. Compress the air with the help of diaphragm and abdominal muscles. Push strongly and long (for 10-15 sec). Breathe out and take another deep breath, hold it and push as strongly as possible for another 10-15 seconds. Stop pushing when contractions are mild. Breathe 2-3 times in normal style. Relax and have a rest until the next contraction.

Data collection tools and forms The data of the study is collected by using Baseline Obstetric Data Form in which demographic, obstetric, and first stage features of labour with features of 2nd, 3rd and 4th stages of pregnancy are registered, and Visual Analogue Fatigue Scale (VAFS).

.Management of Data Collection Tools and Forms Randomization of gravitas participated in the study is done with the help of computers. The second stage of labour is defined as the time passed after the cervical dilatation reaches 10cm. The expulsion stage is the time between the sight of baby's head in the vulva and the end of labour.

The pushing is initiated; when the servical dilatation is 10cm along with strong uterus contractions until foetal head rotation is over and when the foetal head is at least "+1" in the pelvis. In addition, at the onset of pushing in spontaneous group, woman's desire to push is not ignored.

The practices on gravids of our study (spontaneous and Valsalva's pushing) are applied as follows;

  • The participants are given information about the study after self introduction of each gravid is done for completing baseline obstetric data forms by midwives. Also, blood samples for pre and postpartum haemoglobin level changes are collected. The perineal area is examined for postpartum tears through pad checks. Vital findings (respiration, pulse and TA) are evaluated prior to their transfer to the delivery room. Just after the birth, mothers are tested for pH, pO2, pCO2 and lactate levels in blood while the newborns are tested for pH, pO2 (mmHg) and pCO2 levels through umbilical artery along with 1st min and 5 min APGAR analysis. The visual scale is utilized for determination of first 24-hour fatigue and they are recorded in follow-up forms.

Data Assessment The obtained data is assessed through SPSS 22.0 (Statistical Package of Social Science). While assessing these data, along with descriptive statistical methods, tests that are appropriate for data distribution in comparison of quantitative data (mean, standard deviation or median) are utilized. The results are assessed in 95% confidence interval and p<0.05 meaningful.

2.7 Data Analysis Shapiro-Wilk's test was used, histograms and q-q plots were also assessed to test the data normality. Levene test was used to assess variance homogeneity. For comparisons, either two-sided independent samples t test or Mann-Whitney U test was used for continuous variables and chi-square analysis were used for categorical variables. Values are expressed n(%), mean±SD or median(25th-75th percentiles). All analysis were performed using R 3.2.1 (www.r-project.org) software. A p value less than 5% was considered as statistically significant

Being tested
Valsalva's Style Pushing
Keywords
pushing technıques, maternal health, fetal health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Valsalva's Style PushingBehavioural

    The second stage of labour is defined as the time passed after the cervical dilatation reaches 10cm. The expulsion stage is the time between the sight of baby's head in the vulva and the end of labour. the participants are given information about the study after self introduction of each gravid is done for completing baseline obstetric data forms by midwives. Also, blood samples for pre and postpartum haemoglobin level changes are collected. The perineal area is examined for postpartum tears through pad checks. Vital findings (respiration, pulse and TA) are evaluated prior to their transfer to the delivery room. Just after the birth, mothers are tested for pH, pO2, pCO2 and lactate levels in blood while the newborns are tested for pH, pO2 (mmHg) and pCO2 levels through umbilical artery along with 1st min and 5 min APGAR analysis. The visual scale is utilized for determination of first 24-hour fatigue and they are recorded in follow-up forms.

Study groups in NCT04207658
Study groupRoleWhat they receive
Valsalva's PushingExperimentalThe gravitas are informed about spontaneous pushing at the active phase of dilatation (6cm) in second stage of labour and they are encouraged for spontaneous pushing just at the onset of pushing. At the expulsion phase (baby's head is visible in vulva), they are encouraged to perform the Valsalva's manoeuvre that they have practised in routines of delivery; When contractions start, breathe twice normally. Take a deep breath and hold. Compress the air with the help of diaphragm and abdominal muscles. Push strongly and long (for 10-15 sec). Breathe out and take another deep breath, hold it and push as strongly as possible for another 10-15 seconds. Stop pushing when contractions are mild. Breathe 2-3 times in normal style. Relax and have a rest until the next contraction.
Receives: Behavioral: Valsalva's Style Pushing
controlNo interventionPractices on Spontaneous Pushing Group The gravitas are informed about spontaneous pushing at the active phase of dilatation (6cm) in second stage of labour and they are encouraged for spontaneous pushing just at the onset of pushing. Just after feeling the push, the gravitas are requested perform pushing as follows; Breathe normally until participants feel the push when contractions start, pull back muscles surrounding the uterus while breathing. Start pushing gradually and breathe out smoothly by minimizing lips. Push between breaths for 5-6 seconds while pushing downwards by breathing out. Breathe normally when contractions weaken.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Women with valsalva pushing in upright position during second stage of labor will have proper fetal wellbeing than those with spontaneous pushing stage of labor duration and maternal and fetal arterial blood gas tests.

    Just after the birth, mothers are tested for pH, pO2, pCO2 and lactate levels in blood while the newborns are tested for pH, pO2 (mmHg) and pCO2 levels through umbilical artery

    Measured: 15 minutes from birth

  2. Women with valsalva pushing in upright position during second stage of labor will have proper fetal wellbeing than those with spontaneous pushing stage of labor duration and maternal postpartum hemorrhage

    The perineal area is examined for postpartum tears through pad checks.

    Measured: 24 hours from birth.

  3. Women with valsalva pushing in upright position during second stage of labor will have proper fetal wellbeing than those with spontaneous pushing stage of labor duration and newborn APGAR scores.

    1st min and 5 min APGAR analysis for newborn

    Measured: 1st min and 5 minutes from birth.

  4. Women with valsalva pushing in upright position during second stage of labor will have proper fetal wellbeing than those with spontaneous pushing stage of labor duration and maternal vital finding.

    Vital findings (respiration, pulse and TA) are evaluated prior to their transfer to the delivery room.

    Measured: 24 hours from birth.

  5. Women with valsalva pushing in upright position during second stage of labor will have proper fetal wellbeing than those with spontaneous pushing stage of labor duration and maternal haemoglobin level.

    Blood samples for pre and postpartum haemoglobin level changes are collected.

    Measured: 6 and 24 hours from birth.

Secondary outcomes (5)
  1. Women with spontaneous pushing in upright position during second stage of labor will have proper fetal wellbeing than those with valsalva pushing stage of labor duration and maternal haemoglobin level.

    Blood samples for pre and postpartum haemoglobin level changes are collected.

    Measured: 6 and 24 hours from birth.

  2. Women with spontaneous pushing in upright position during second stage of labor will have proper fetal wellbeing than those with valsalva pushing stage of labor duration and maternal and fetal arterial blood gas tests.

    just after the birth, mothers are tested for pH, pO2, pCO2 and lactate levels in blood while the newborns are tested for pH, pO2 (mmHg) and pCO2 levels through umbilical artery

    Measured: 15 minutes from birth

  3. Women with spontaneous pushing in upright position during second stage of labor will have proper fetal wellbeing than those with valsalva pushing stage of labor duration and maternal postpartum hemorrhage

    The perineal area is examined for postpartum tears through pad checks.

    Measured: 24 hours from birth.

  4. Women with spontaneous pushing in upright position during second stage of labor will have proper fetal wellbeing than those with valsalva pushing stage of labor duration and newborn APGAR analysis

    1st min and 5 min APGAR analysis for newborn

    Measured: 1st min and 5 minutes from birth.

  5. Women with spontaneous pushing in upright position during second stage of labor will have proper fetal wellbeing than those with valsalva pushing stage of labor duration and maternal Vital findings.

    Vital findings (respiration, pulse and TA) are evaluated prior to their transfer to the delivery

    Measured: 24 hours from birth.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2019
  2. Study start1 Feb 2017
  3. Primary completion15 Nov 2017
  4. Study completion20 May 2018

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The data of the study is collected by using Baseline Obstetric Data Form in which demographic, obstetric, and first stage features of labour with features of 2nd, 3rd and 4th stages of pregnancy are registered, and Visual Analogue Fatigue Scale (VAFS). .Management of Data Collection Tools and Forms Randomization of gravitas participated in the study is done with the help of computers. The second stage of labour is defined as the time passed after the cervical dilatation reaches 10cm. The expulsion stage is the time between the sight of baby's head in the vulva and the end of labour. The pushing is initiated; when the servical dilatation is 10cm along with strong uterus contractions until foetal head rotation is over and when the foetal head is at least "+1" in the pelvis. In addition, at the onset of pushing in spontaneous group, woman's desire to push is not ignored.
Masking
Single blind
Who is masked
Participant
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04207658
Sponsor's protocol ID
ERU
Status last verified
Dec 2019
First submitted
8 Nov 2019
Last updated
23 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Valsalva's Style Pushing in people with Prevention and Newborn Complication, run by TC Erciyes 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 6 inclusion and 2 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 23 Dec 2019. 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?

Women with valsalva pushing in upright position during second stage of labor will have proper fetal wellbeing than those with spontaneous pushing stage of labor duration and maternal and fetal arterial blood gas tests. (time frame: 15 minutes from birth). The study lists 5 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 23 Dec 2019.

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