Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05084326 |
| Other study ID # |
AinShamsU Hos |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 3, 2020 |
| Est. completion date |
November 20, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
