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Labor Onset and Length AbnormalitiesNCT05084326

Engagement of Fetal Head as a Predictor of a Successful Vaginal Delivery in Primigravidas Presented in Early Labor.

An observational study of Labor Onset and Length Abnormalities, run by mohamed abosena at 1 site in Egypt.

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

In primigravida, Delayed engagement of fetal head has been theorized that it is more likely in women with a possible cephalo-pelvic disproportion, so far they are associated with higher risk of cervical dystocia, which led to increased rate of caesarean section. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Labor Onset and Length Abnormalities
What is being tested?
Engagement of fetal head as a predictor of a successful vaginal delivery
Type of treatment
Surgery or procedure
How many people
226 participants
Where
1 siteEgypt
Study dates
3 Nov 2020to 20 Nov 2021
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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: primigravidas, full term in early labor, Ain shams maternity hospital.

Who may be able to join

  • Term pregnancy (37-42) weeks.
  • Expected foetal birth weight of 2.5-4.0 kg on USG at term.
  • Singleton live pregnancy.
  • Cephalic presentation.
  • Cervical dilatation of =/< 4cms.
  • Reactive CTG at onset of labour.
  • Confirmation of ROM by Direct visualization or Fern test.

Who cannot join

  • Contracted pelvis.
  • Previous uterine surgery " upper segment ".
  • Pregnancy complications like antepartum haemorrhage, pregnancy induced hypertension, gestational diabetes mellitus, IUGR.
  • Fetal congenital anomalies.
  • Abnormal or non reassuring fetal CTG at term or at onset of labour.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain Shams university

    Cairo, 11511

Other trials in Egypt

About this study

Official title: Engagement of Fetal Head as a Predictor of a Successful Vaginal Delivery in Primigravidas Presented in Early Labor

In primigravida, Delayed engagement of fetal head has been theorized that it is more likely in women with a possible cephalo-pelvic disproportion, so far they are associated with higher risk of cervical dystocia, which led to increased rate of caesarean section.

Read the detailed description

This study will involve total 226 of " 113 primigravida patients with engaged head and 113 primigravida patients with unengaged head .

while assessment of fetal head station, status of membrane should be evaluated and noted.

Engagement will be assessed by vaginal examination as described by Müller in 1868 , assumes that when the leading edge of the vertex is felt at the level of the ischial spines, the biparietal diameter will have just passed through the pelvic brim. The leading edge of the vertex at the level of the ischial spines is designated as being at station 0. If the leading edge is 1 cm below the level of the spines, this is referred to as station +1. Usually, a head on the pelvic floor is at station +4 or +5.

Uengaged head is still 2 cm above the level of the spines is at station -2, and so on.

The aim of this study will be to determine if primigravida patients with unengaged head after spontaneous onset of labor are at increased risk of cesarean section.

The patients will be admitted in the labour room. Name, age and detailed history will be noted A thorough general examination and systemic examination will be done to determine the fundal height, the baby's lie, presentation, position, engagement of the presenting part, and frequency and duration of contractions, auscultation of the fetal heart rate for a minimum of 1 minute immediately after a contraction.

A vaginal examination will be offered for more assessment of pelvic status, cervical dilation (in cm) and effacement, position of fetal head and status of membrane will be evaluated and noted.

Assessment of labor progress will be done by digital examination : to document cervical dilation, effacement, and fetal station are usually routinely performed:

  • At four hour intervals in the first stage
  • Prior to administering analgesia/anesthesia*
  • When the parturient feels the urge to push (to determine whether the cervix is fully dilated)
  • At one hour intervals in the second stage
  • If fetal heart rate abnormalities occur " to evaluate for complications such as cord prolapse "
  • All patients should be counselled and offered Epidural anesthesia during first and second stage of labor.

Observations during the established frst stage:

  1. Half-hourly documentation of frequency of contractions
  2. Hourly pulse
  3. 4-hourly temperature and blood pressure
  4. A vaginal examination 4-hourly or if there is concern about progress

If delay is established in first stage of labour of cervical dilatation of less than 2 cm in 4 hours for frst labour , amniotomy should be considered for all women with intact membranes increase the strength and pain of contractions, in normally progressing labour, do not perform amniotomy routinely.

vaginal examination 2 hours later, and diagnose delay if progress is less than 1 cm.

increase the strength and pain of contractions, vaginal examination 2 hours later, and diagnose delay if progress is less than 1 cm.

Decision about management options of oxytocin augmentation according NICE guidelines should considered.

According to RCOG guidelines, we will use a low-dose protocol for all patients, by adding 10 IU oxytocin to 1 litre of 0.9% normal saline.

Electronic fetal monitoring will be performed for a minimum of 20 minutes before starting oxytocin, and will be continued until the baby is delivered, intervention will be according to interpretation of CTG.

According to NICE guidelines, vaginal examination 4 hours after starting oxytocin in established labour:

  • If cervical dilatation has increased by less than 2 cm after 4 hours of oxytocin, further obstetric review is required to assess the need for caesarean section.
  • If cervical dilatation has increased by 2 cm or more, advise 4-hourly vaginal examinations.

Observations during the second stage:

  1. Half-hourly documentation of the frequency of contractions.
  2. Hourly blood pressure.
  3. Continued 4-hourly temperature.
  4. Frequency of passing urine .
  5. A vaginal examination hourly in the active second stage.
Being tested
Engagement of fetal head as a predictor of a successful vaginal delivery

What participants receive

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

  • Engagement of fetal head as a predictor of a successful vaginal deliveryProcedure or surgery

    In addition to the fetal lie, presentation, and position, the level or station of the presenting part in the maternal pelvis is an important factors in the labor process.

    In primigravida, Delayed engagement of fetal head has been theorized that it is more likely in women with a possible cephalo-pelvic disproportion, so far they are associated with higher risk of cervical dystocia, which led to increased rate of caesarean section.

Study groups in NCT05084326
Study groupRoleWhat they receive
MohamedabosenaNot described
Receives: Procedure: Engagement of fetal head as a predictor of a successful vaginal delivery

What is being measured

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

  1. Incidence of cesarean section in primigravidas with unengaged fetal head in compare to primigavidas with engaged fetal head .

    section in primigravidas with unengaged fetal head in compare to primigavidas with engaged fetal head .

    Measured: 24 hours

Secondary outcomes (1)
  1. Duration of labor progress in patients with unengaged

    Duration of labor progress in patients with unengaged fetal head in relation to patients with engaged fetal head

    Measured: 24 Hours

Timeline

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

  1. First posted19 Oct 2021
  2. Study start3 Nov 2020
  3. Primary completion3 Oct 2021
  4. Study completion20 Nov 2021

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
Cohort
Time perspective
Prospective
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05084326
Sponsor's protocol ID
AinShamsU Hos
Status last verified
Jan 2022
First submitted
3 Oct 2021
Last updated
21 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Labor Onset and Length Abnormalities, run by mohamed abosena at 1 site in Egypt.

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 7 inclusion and 5 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 21 Jan 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 Egypt. 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?

Incidence of cesarean section in primigravidas with unengaged fetal head in compare to primigavidas with engaged fetal head . (time frame: 24 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 21 Jan 2022.

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