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.
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.
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:
- Half-hourly documentation of frequency of contractions
- Hourly pulse
- 4-hourly temperature and blood pressure
- 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:
- Half-hourly documentation of the frequency of contractions.
- Hourly blood pressure.
- Continued 4-hourly temperature.
- Frequency of passing urine .
- A vaginal examination hourly in the active second stage.
- Conditions
- Labor Onset and Length Abnormalities
- 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 group | Role | What they receive |
|---|---|---|
| Mohamedabosena | Not 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.
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)
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.
- First posted19 Oct 2021
- Study start3 Nov 2020
- Primary completion3 Oct 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor Onset and Length AbnormalitiesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- mohamed abosena
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, mohamed abosena, Ain Shams University
- Investigators
- Mohamed M sami, Consultant, Study director, As.Professor
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engagement of Fetal Head as a Predictor of a Successful Vaginal Delivery in Primigravidas Presented in Early Labor
- ClinicalTrials.gov ID
- NCT05084326
- Acronym / sponsor ID
- AinShamsU Hos
- Conditions
- Labor Onset and Length Abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- mohamed abosenaUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 3 Oct 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 19 Oct 2021 (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.
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.
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:
- Half-hourly documentation of frequency of contractions
- Hourly pulse
- 4-hourly temperature and blood pressure
- 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:
- Half-hourly documentation of the frequency of contractions.
- Hourly blood pressure.
- Continued 4-hourly temperature.
- Frequency of passing urine .
- A vaginal examination hourly in the active second stage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mohamedabosena | – | Procedure: Engagement of fetal head as a predictor of a successful vaginal delivery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primigravidas, full term in early labor, Ain shams maternity hospital.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Engagement of fetal head as a predictor of a successful vaginal deliveryIn 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. | Procedure or surgery | Mohamedabosena |
Primary outcome
Incidence of cesarean section in primigravidas with unengaged fetal head in compare to primigavidas with engaged fetal head .
Time frame: 24 hours
section in primigravidas with unengaged fetal head in compare to primigavidas with engaged fetal head .
1 secondary outcome
Duration of labor progress in patients with unengaged
Time frame: 24 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 21 Jan 2022.
- Individual participant dataSharing planned: No
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Recruiting
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Labor Dystocia, Labor Complication
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.
Mohamed M sami, Consultant study director
As.Professor
1 site in 1 country: see every site and its status.
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.