Clinical trial NCT03430804: Transvaginal Sonographic Measurement of Cervical Length Versus Bishop Score in Induction of Labour for Prediction of Caesarean Delivery.
Official title: Transvaginal Sonographic Measurement of Cervical Length Versus Bishop Score in Induction of Labour at Term for Prediction of Caesarean Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Failed Induction
Cervical Dystocia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Single group 320 parturients udergoing induction of labour at term

Brief summary: Transvaginal sonographic measurement of cervical length versus Bishop score in labour induction at term for prediction of Caesarean delivery. This study is prospective study. This study will be carried out in Ain-shams maternity hospital. Sample size of 320 parturients.

Detailed description: Patients and Methods

Study design:

This study is prospective study, comparative clinical trial for a test against a gold standard with blinding of the evaluator

Study setting:

This study will be carried out in Ain-Shams university maternity hospital.

Methods:

* All patients recruited were given an oral consent.
* All patients were subjected to the following:

History of the patient:

* Detailed and careful history was taken from the patient as the following:

  1. Personal history: name, age, occupation, residence and special habit of medical importance.
  2. Obstetric history: including last menstrual period, Gestation 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 patient:

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  1. General examination: as regard level of consciousness, vital data, and complexion.
  2. Abdominal examination: as regard fundal level, lie of the fetus, detection of any uterine contractions and fetal heart rate.
  3. Pelvic Examination: as regard pelvic capacity, presenting part, presence of rupture of membranes and cervical assessment as regard cervical dilation, station and presenting part.
* Investigations. Complete blood count , Rh, transvaginal ultra sound and non-stress test.
* All patients had vaginal examination for assessing the (Bishop Score,1964) before induction of labour.
* All women had transvaginal ultrasound for assessment of cervical length using (median digital GAIA) Ultrasonic machine.

Protocol of transvaginal ultrasound will be done as follow:

1. Patient will be asked to void.
2. Vaginal probe will be inserted using direct visualization with K-Y gel.
3. Identification of bladder, amniotic fluid and fetal presenting part.
4. Identification of abnormal findings as placenta pervia or absence of fetal heart motion.
5. Identification of midline sagittal plane of the cervix and looking in the proximal one third of the image for the internal 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 by placing the calipers appropriately and recording the distance between internal and external cervical os.

   * Transvaginal ultrasound will be done to assess cervical length using medison sonoace 8800 (median digital GAIA) ultrasound machine equipped with a 7.5 m hertz by vaginal probe in Ain-Shams University Maternity Hospital.
   * Induction of labour will be done using intravaginal misoprostol (25 microgram) then digital examination will be made 6 h after the first intravaginal administration; if necessary, 3 doses were given at 6 hours interval. External Cardiotocography will be regularly performed to monitor the condition of the fetus.
   * Continuous Cardiotocography will be used in all cases. If necessary, amniotomy will be performed. Intravenous oxytocin administration will be started when there is an arrest of dilatation, starting at 1milli-international unit/minute and increasing 1 mIU every 30 min as necessary. For analgesia, intramuscular pethidine will be offered.
   * Caesarean delivery will be done due to pathological fetal heart rate trace, arrest the fetal head for at least one hour despite adequate uterine contractions.

Eligibility criteria: Inclusion Criteria:

* 1. Age (18-35) years. 2. Singleton pregnancy. 3. (37-42) weeks gestation. 4. Living fetus. 5. Cephalic presentation. 6. Absence of active labour. 7. No contraindication to vaginal delivery. 8. Average amount of clear liquor. 9. No history of uterine scar (myomectomy or previous C.S(.

Exclusion Criteria:

* 1. Malpresentation. 2. Major fetal congenital anomalies as hydrocephalous \& dead fetus. 3. Patient received any pre induction ripping methods for example: (Acetic Acid-Prostaglandins).

  4. Any medical history contraindicating vaginal delivery. 5. Assessment meconium staining to liquor or any evidence of chorioamnionitis. 6. Previous uterine surgery. 7. Multiple gestations. 8. Women with allergy to prostaglandins.

Primary outcomes:
measure: Cervical length
timeFrame: 24 hours
measure: Bishop score
timeFrame: 72
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Mohamed adel mazroa
Study officials:
References: