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Comparison between Sonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment prior to induction of labor as regards induction success.
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:
Examination of the participants:
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:
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 prostaglandin 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction of labor | 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 participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bishop score | Other | calculation of modified Bishop score in numbers by digital vaginal examination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cervical Length Prior to Labor Induction | median cervical length measured by transvaginal ultrasound in centimetres | 24 hours |
| Bishop Score Prior to Induction of Labor | median Bishop score assessed by digital vaginal examination as follows:
Note that a score more than 10 means patient is in labor not needing induction of labor. | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams maternity hospital | Cairo | Egypt |
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| ID | Title | Description |
|---|---|---|
| FG000 | Induction of Labor | 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 participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length. Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination cervical length: measuring cervical length by trans-vaginal ultrasound |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Raslan et al., 2013 reported accuracy of cervical length or Bishop score was 72% vs 63%. So, proportion of discordant pairs is 0.37. A sample of 200 would achieve a power of 80% to detect statistical significance for an effect size equivalent to odds ratio of 1.9. Two sided McNemar test was used with a confidence level 95%.
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| ID | Title | Description |
|---|---|---|
| BG000 | Induction of Labor | 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 participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length. Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination cervical length: measuring cervical length by trans-vaginal ultrasound |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cervical Length Prior to Labor Induction | median cervical length measured by transvaginal ultrasound in centimetres | Posted | Median | Inter-Quartile Range | centimetres | 24 hours |
|
|
All participants and their livebirths were followed for 72 hours following delivery for adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Induction of Labor | 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 participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length. Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination cervical length: measuring cervical length by trans-vaginal ultrasound |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| low APGAR score | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | neonatal APGAR score less than 7 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| amr ahmed mahmoud riad | Ain Shams Maternity hospital | 01005347179 | +2 | amr.riad@med.asu.edu.eg |
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| cervical length | Other | measuring cervical length by trans-vaginal ultrasound |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Gestational age | Median | Inter-Quartile Range | weeks |
|
| Previous abortions | Number | participants |
|
| Indication of induction of labor | Number | participants |
|
| Need for oxytocin | Number | participants |
|
| Outcome of induction of labor | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Bishop Score Prior to Induction of Labor | median Bishop score assessed by digital vaginal examination as follows:
Note that a score more than 10 means patient is in labor not needing induction of labor. | Posted | Median | Inter-Quartile Range | units on a scale | 72 hours |
|
|
|
| 0 |
| 200 |
| 19 |
| 200 |
|
| low birth weight | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | fetal birth weight less than 2500 grams |
|
| neonatal ICU admission | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | number of neonates admitted in neonatal ICU |
|
| maternal traumatic birth injury | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | any trauma in the birth tract related to delivery |
|
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