Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02694315 |
| Other study ID # |
sonographic cervical length |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
February 23, 2016 |
| Last updated |
March 1, 2016 |
| Start date |
October 2014 |
| Est. completion date |
March 2016 |
Study information
| Verified date |
March 2016 |
| Source |
Ain Shams Maternity Hospital |
| Contact |
Amr A Riad, MD |
| Phone |
01005347179 |
| Email |
amr.riad[@]med.asu.edu.eg |
| Is FDA regulated |
No |
| Health authority |
Egypt: Ministry of Health and Population |
| Study type |
Observational
|
Clinical Trial Summary
Comparison between Sonographic Cervical Length and Bishop Score in Preinduction Cervical
Assessment prior to induction of labor as regards induction success.
Description:
Type of the study:
assessment of accuracy of diagnostic test.
Study setting:
The study will be performed at Ain Shams university Maternity hospital on nulliparous women
at term admitted to causality for induction of labor.
Study population:
The study will be held on 200 women all are primigravida between 37-42 weeks gestation to
whom induction of labor will be carried out in the casualty of Ain Shams University
Maternity Hospital.
All patients will have cervical assessment by modified Bishop score and cervical length
measurement by ultrasound.
Plan for induction of labor:
- Detailed and careful history will be taken from the participants as follows:
1. Personal history: including name, age, occupation, residence and special habits of
medical importance.
2. Obstetric history: including gestational age and regular antenatal care.
3. Past history: including any medical disorder e.g Diabetes mellitus, hypertension
or any surgical procedure.
4. History of present pregnancy: duration of pregnancy from last menstrual period,
any complications occurred or any medication used during pregnancy.
- Examination of the participants:
1. General examination: level of consciousness, vital data, complexion.
2. Abdominal examination: fundal level, lie of the fetus, detection of any uterine
contractions and fetal heart rate.
3. Pelvic Examination : presenting part, presence of ruptured membranes and cervical
assessment as regard cervical dilation, effacement, station and presenting part to
calculate the modified Bishop Score.
- Investigations: complete blood count, blood group, non stress test.
- All women will have trans-vaginal ultrasound sound for assessment of cervical length.
- Protocol of trans-vaginal ultrasound will be as follows:
1. Patient will be asked to void.
2. Vaginal probe will be inserted using direct visualization.
3. Identification of bladder and fetal presenting part.
4. Identification of abnormal findings as placenta previa or absence of fetal heart
motion.
5. Identification of mid-line sagital plane of the cervix and looking in the proximal
one third of the image for the internal cervical os then pulling back the probe
until the lightest touch provides good image of the cervical canal and moving the
probe slightly to get the best long axis of the cervix then measuring the cervical
length three times by placing the calibers appropriately and recording the
distance between internal and external os then at last recording the measurement
of the best image .
- If cervical length assessed by trans-vaginal ultrasound is less than 28 mm or modified
Bishop Value is less than 7, the patient will receive 3mg prostaglandine E2 for
pre-induction cervical ripening to be repeated after 6 hours with maximum of 2 doses.
If failed cervical ripening, Cesarean section will be done.
- All Patients will be tested by antepartum fetal heart monitoring "Non stress test".This
will be considered reactive if there are two or more fetal heart rate accelerations
peaking at least by 15 beats/min above the baseline and lasting for 15 seconds or more
from baseline, within a 20 minutes period, with or without fetal movement felt by the
mother. A non-reactive tracing will be one without sufficient fetal heart rate
accelerations over a 40 minutes period. Any patient with non-reassuring non stress test
will be excluded.
- Successful induction will be defined as vaginal delivery within 24 hours.
- Failed induction after 24 hours will indicate lower segment cesarean section. Failed
induction will be defined as an inability to achieve the active phase of labor
corresponding to a cervical dilatation ≥4 cm within 12 hours of initiating oxytocin.
Failure of progress was defined as no cervical dilatation during the active phase of
labor for at least 2 hours or no descent of the fetal head during the second stage of
labor for at least 1 hour despite adequate uterine contraction. This will be considered
an indication for cesarean delivery.
- No further induction agent will be given when uterine contractions reach frequency of
three in ten minutes each lasting 30-60 seconds with cervical changes. Amniotomy and
oxytocin augmentation will begin when cervical dilation becomes > 3 cm.
- Oxytocin infusion will be prepared by placing 5 IU ampoule in 500 ml Ringer or Saline
to achieve concentration of 10 ml\minute.
- The rate of infusion will be started at a rate of 5 miu/ml (about 10 drops per minute)
and will be increased at same increment every 20 minutes according to uterine
contractions.
- When the patient become in the active phase of labor, vaginal examination will be
repeated every 1-2 hours to know the rate of cervical dilation.
- If patient requests pain relieve, epidural analgesia will be used.
- Fetal heart rate will be recorded every half an hour.
- Labor progress will be plotted on partogram.
