NCT04207658

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

November 8, 2019

Last Update Submit

December 18, 2019

Conditions

PreventionNewborn Complication

Keywords

pushing technıquesmaternal healthfetal health

Outcome Measures

Primary Outcomes (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 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

    15 minutes from birth

  • 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.

    24 hours from birth.

  • 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

    1st min and 5 minutes from birth.

  • 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.

    24 hours from birth.

  • 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.

    6 and 24 hours from birth.

Secondary Outcomes (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 haemoglobin level.

    6 and 24 hours from birth.

  • 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.

    15 minutes from birth

  • 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

    24 hours from birth.

  • 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 minutes from birth.

  • 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.

    24 hours from birth.

Study Arms (2)

Valsalva's Pushing

EXPERIMENTAL

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.

Behavioral: Valsalva's Style Pushing

control

NO INTERVENTION

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.

Interventions

Valsalva's Style PushingBEHAVIORAL

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.

Valsalva's Pushing

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evrim Bayraktar

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Location

Study Officials

  • Evrim Bayraktar

    Erciyes Üniversitesi Sağlık Bilimleri Fakültesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof.

Study Record Dates

First Submitted

November 8, 2019

First Posted

December 23, 2019

Study Start

February 1, 2017

Primary Completion

November 15, 2017

Study Completion

May 20, 2018

Last Updated

December 23, 2019

Record last verified: 2019-12

Locations

TU(1)