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The Length of Second Labor Stage in Primigravidae on Maternal & Neonatal OutcomesRCTNCT02676505

Effect of the Length of Second Stage of Labor in Primigravidae on Maternal & Neonatal Outcomes

An observational study of The Length of Second Labor Stage in Primigravidae on Maternal & Neonatal Outcomes, run by Kasr El Aini Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary purpose of this study is to compare the effects of two different methods of care during the second stage of labor for nulliparous women (coached versus uncoached pushing) on the length of the second stage and how this may affect maternal and neonatal outcome. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
What is being tested?
Coached pushing group and uncoached pushing group
How many people
434 participants
Where
No sites listed yet
Study dates
Nov 2015to May 2016
How long will I take part?
6 Months
Phase
Observational
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 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: The study was conducted on 434 primigravidae women admitted to Kasr El Ainy teaching Maternity Hospital for labor. The study will be done in the period between October 2015 and April 2016. The study will include 434 women with the diagnosis of the first stage of labor with at least cervical dilatation 4cm.

Who may be able to join

  • All patients admitted in the first stage of labor with cervical dilatation of 4 cm at least:
  • Women age 18-35 years.
  • 37-41 weeks gestation pregnancy.
  • Singleton pregnancy and vertex presentation.
  • Women have no chronic or pregnancy-induced illnesses.
  • Women are in established, spontaneous labor.

Who cannot join

  • Malpresentation.
  • Women with previous uterine scar.
  • Multiple pregnancy
  • Ante partum hemorrhage.
  • Cephalopelvic disproportion.
  • Women have chronic illnesses.
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  • Women with abnormal antenatal period.
  • Patients with foetal distress
  • Premature rupture of membrane
  • Woman having any contraindication to vaginal delivery.

About this study

The primary purpose of this study is to compare the effects of two different methods of care during the second stage of labor for nulliparous women (coached versus uncoached pushing) on the length of the second stage and how this may affect maternal and neonatal outcome.

Read the detailed description

The study was conducted on 434 primigravidae women admitted to Kasr El Ainy teaching Maternity Hospital for labor. The study will be done in the period between October 2015 and April 2016. The study will include 434 women with the diagnosis of the first stage of labor with at least cervical dilatation 4cm.

Ethical approval obtained and an informed consent will be taken from each patient after explaining the nature and scope of the study.

Methodology in details:

  1. Careful and detailed history taking regarding:
  • Personal history
  • Complaint.
  • History of present pregnancy.
  • Menstrual History.
  • Past history.
  1. Careful general examination.
  2. Abdominal examination.
  3. Local vaginal examination.
  4. Ultrasound examination.

Management of Cases:

Group (I)(Coached group):

It includes 217 patients who are admitted in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward. They are coached by the nurse to use closed-glottis and pushing three to four times during each contraction immediately when cervical dilation reached 10 cm and to continue pushing using this method with each contraction until birth. The nurse counts to 10 during each pushing effort to assist the woman in holding her breath for at least 10 seconds.

Group (II)(Uncoached group):

It includes 217 patients who are admitted early in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward at 10-cm cervical dilation where they remain until they feel the urge to push or the second stage had lasted 2 hours (whichever came first)., they are encouraged to bear down with contractions without holding their breath (open-glottis) for no more than 6-8 seconds and continue bearing down no more than three times with each contraction until birth. .

Patients admitted early in labor are subjected to active management of labor as follows:

Pelvic examination performed. Routine amniotomy performed and progress assessed. When dilatation is not increasing, a low dose protocol of oxytocin infusion will be started. Oxytocin diluted in the form of 5IU in 500 ml Ringer lactate making a concentration of nearly 1mu oxytocin/1ml Ringer solution. Infusion instituted at a rate of 1 -2 milliunit (15-30 drops) per minute and increased gradually in increments of 1 -2 milliunit per minute at 30 minutes interval, until at least three uterine contractions noted in a 10 minute period using cardio tocograph.

Assessment of each stage of labor was performed as follow:

  1. First stage of labor: It includes:
  • Duration of the first stage of labor.
  • Rate of cervical dilatation and foetal descent.
  • Adequacy of uterine contractions and documentation of labor dystocia.
  • Excess uterine activity consisted of uterine tachysystole, hypertonus or uterine hyperstimulation
  1. Second stage of labor: It includes:
  • Duration of the second stage.
  • Rate of the descent of foetus.
  • Monitoring of foetal heart rate every 5 minutes by sonicaid or continuous by CTG.
  • Use of mediolateral episiotomy.
  • Intervention will be considered either by instrumental delivery,fundal pressure or by CS If the second stage is prolonged more than 2 hours.
  • Monitoring of maternal oxygen saturation by pulse oximeter.
  1. Third stage of labor:
  • Duration of the third stage.
  1. Assessment of any vaginal laceration or perineal tears with their repair as well as repair of episiotomy.
  2. Assessment of quantity of blood loss and assessment of uterine atony(vital instability,number of soaked pads and hemoglobin drop) .
  3. Rate of caesarean section during varying stages of labor.
  4. Neonatal assessment:

It includes:

  • Foetal sex and body weight.
  • APGAR score at 1 and 5 minutes..
Being tested
Coached pushing group, uncoached pushing group

What participants receive

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

  • Coached pushing groupBehavioural

    It includes 217 patients who are admitted in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward. They are coached by the nurse to use closed-glottis and pushing three to four times during each contraction immediately when cervical dilation reached 10 cm and to continue pushing using this method with each contraction until birth. The nurse counts to 10 during each pushing effort to assist the woman in holding her breath for at least 10 seconds.

  • uncoached pushing groupBehavioural

    It includes 217 patients who are admitted early in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward at 10-cm cervical dilation where they remain until they feel the urge to push or the second stage had lasted 2 hours (whichever came first)., they are encouraged to bear down with contractions without holding their breath (open-glottis) for no more than 6-8 seconds and continue bearing down no more than three times with each contraction until birth. .

Study groups in NCT02676505
Study groupRoleWhat they receive
1Group (I)(Coached group): It includes 217 patients who are admitted in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward. They are coached by the nurse to use closed-glottis and pushing three to four times during each contraction immediately when cervical dilation reached 10 cm and to continue pushing using this method with each contraction until birth. The nurse counts to 10 during each pushing effort to assist the woman in holding her breath for at least 10 seconds.
Receives: Behavioral: Coached pushing group
2It includes 217 patients who are admitted early in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward at 10-cm cervical dilation where they remain until they feel the urge to push or the second stage had lasted 2 hours (whichever came first)., they are encouraged to bear down with contractions without holding their breath (open-glottis) for no more than 6-8 seconds and continue bearing down no more than three times with each contraction until birth.
Receives: Behavioral: uncoached pushing group

What is being measured

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

  1. Duration of the second stage

    Measured: 0-3 hours

Secondary outcomes (2)
  1. Severe maternal morbidity e.g post partum hemorrhage

    Measured: intrapartum and 2 hours postpartum.

  2. APGAR score after one and five minutes.

    Measured: 1-5 minutes

Timeline

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

  1. First posted8 Feb 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionMay 2016 (estimated)
  4. Study completionMay 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
434 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02676505
Sponsor's protocol ID
KasrELAini maternity hospital
Acronym
RCT
Status last verified
Feb 2016
First submitted
20 Nov 2015
Last updated
8 Feb 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of The Length of Second Labor Stage in Primigravidae on Maternal & Neonatal Outcomes, run by Kasr El Aini Hospital.

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 10 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: status not confirmed, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Duration of the second stage (time frame: 0-3 hours). 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 8 Feb 2016.

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