An observational study in Cervical Dystocia, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to female participants aged 17 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-07.
Sponsored by Ain Shams Maternity Hospital · Observational
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:
Protocol of trans-vaginal ultrasound will be as follows:
Ain Shams Maternity Hospital is the lead sponsor of 139 studies on the registry; 8 are open to participants now.
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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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Exclusion Criteria:
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.
Other: Bishop score · Other: cervical length
calculation of modified Bishop score in numbers by digital vaginal examination
measuring cervical length by trans-vaginal ultrasound
Cervical Length Prior to Labor Induction
median cervical length measured by transvaginal ultrasound in centimetres
Time frame: 24 hours
Bishop Score Prior to Induction of Labor
median Bishop score assessed by digital vaginal examination as follows: 1. Cervical dilatation in centimeters will be given a score of zero if closed, a score of 1 if 1-2 cm dilated, a score of 2 if 3-4 cm dilated and a score of 3 if 5 cm or more dilataion. 2. Effacement of the cervix will be given a score of zero if 0-30%, a score of 1 if 40-50%, a score of 2 if 60-70% and a score of 3 if 80% or more. 3. Station of fetal head will be given a score of zero if -3, a score of 1 if -2, a score of 2 if -1 to zero and a score of 3 if 1 or more. 4. Consistency of the cervix will be given a score of zero if firm, a score of 1 if medium and a score of 2 if soft. 5. Position of the cervix will be given a score of zero if posterior, a score of 1 if mid position and a score of 2 if anterior. So, a total score (sum of all scores) of zero at a minimum to 10 at a maximum can be estimated. Note that a score more than 10 means patient is in labor not needing induction of labor.
Time frame: 72 hours
| Milestone | Induction of Labor |
|---|---|
| Started | 200 |
| Completed | 200 |
| Not completed | 0 |
median cervical length measured by transvaginal ultrasound in centimetres
| centimetres | Induction of Labor |
|---|---|
| successful induction of labor | 2.9 (2.8 to 3.1) |
| failed induction of labor | 3 (2.8 to 3.2) |
median Bishop score assessed by digital vaginal examination as follows: 1. Cervical dilatation in centimeters will be given a score of zero if closed, a score of 1 if 1-2 cm dilated, a score of 2 if 3-4 cm dilated and a score of 3 if 5 cm or more dilataion. 2. Effacement of the cervix will be given a score of zero if 0-30%, a score of 1 if 40-50%, a score of 2 if 60-70% and a score of 3 if 80% or more. 3. Station of fetal head will be given a score of zero if -3, a score of 1 if -2, a score of 2 if -1 to zero and a score of 3 if 1 or more. 4. Consistency of the cervix will be given a score of zero if firm, a score of 1 if medium and a score of 2 if soft. 5. Position of the cervix will be given a score of zero if posterior, a score of 1 if mid position and a score of 2 if anterior. So, a total score (sum of all scores) of zero at a minimum to 10 at a maximum can be estimated. Note that a score more than 10 means patient is in labor not needing induction of labor.
| units on a scale | Induction of Labor |
|---|---|
| successful induction of labor | 4 (3 to 5) |
| failed induction of labor | 3 (3 to 4) |
Collected over All participants and their livebirths were followed for 72 hours following delivery for adverse events. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Induction of Labor | — | 0/200 (0%) | 19/200 (9.5%) |
| Event | Induction of Labor |
|---|---|
| low APGAR scorePregnancy, puerperium and perinatal conditions | 10/200 |
| neonatal ICU admissionPregnancy, puerperium and perinatal conditions | 5/200 |
| maternal traumatic birth injuryPregnancy, puerperium and perinatal conditions | 3/200 |
| low birth weightPregnancy, puerperium and perinatal conditions | 1/200 |
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%.
| Age, Continuous(years) | Induction of Labor |
|---|---|
| Median | 23.5 (21 to 27) |
| Sex: Female, Male(Participants) | Induction of Labor |
|---|---|
| Female | 200 |
| Male | 0 |
| Gestational age(weeks) | Induction of Labor |
|---|---|
| Median | 39.8 (38.2 to 40.4) |
| Previous abortions(participants) | Induction of Labor |
|---|---|
| no abortions | 173 |
| one abortion | 22 |
| two abortions | 4 |
| three abortions | 1 |
| Indication of induction of labor(participants) | Induction of Labor |
|---|---|
| severe pre-eclampsia | 8 |
| mild pre-eclampsia | 11 |
| intrauterine growth restriction | 3 |
| oligohydramnios | 17 |
| postdate | 89 |
| term rupture of membranes | 72 |
| Need for oxytocin(participants) | Induction of Labor |
|---|---|
| needed oxytocin | 116 |
| did not need oxytocin | 84 |
| Outcome of induction of labor(participants) | Induction of Labor |
|---|---|
| successful vaginal delivery | 114 |
| need for cesarean section | 86 |
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Oct 2014, a primary completion of Mar 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2016, 8 months after primary completion.
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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