Trial Outcomes & Findings for Cervical Length and Bishop Score in Preinduction Cervical Assessment Prior to Induction of Labor (NCT NCT02694315)

NCT ID: NCT02694315

Last Updated: 2016-11-07

Results Overview

median cervical length measured by transvaginal ultrasound in centimetres

• Recruitment status: COMPLETED
• Target enrollment: 200 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2016-11-07

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	200
Overall Study COMPLETED	200
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cervical Length and Bishop Score in Preinduction Cervical Assessment Prior to Induction of Labor

Baseline characteristics by cohort

Measure	Induction of Labor n=200 Participants 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
Age, Continuous	23.5 years n=5 Participants
Sex: Female, Male Female	200 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Gestational age	39.8 weeks n=5 Participants
Previous abortions no abortions	173 participants n=5 Participants
Previous abortions one abortion	22 participants n=5 Participants
Previous abortions two abortions	4 participants n=5 Participants
Previous abortions three abortions	1 participants n=5 Participants
Indication of induction of labor severe pre-eclampsia	8 participants n=5 Participants
Indication of induction of labor mild pre-eclampsia	11 participants n=5 Participants
Indication of induction of labor intrauterine growth restriction	3 participants n=5 Participants
Indication of induction of labor oligohydramnios	17 participants n=5 Participants
Indication of induction of labor postdate	89 participants n=5 Participants
Indication of induction of labor term rupture of membranes	72 participants n=5 Participants
Need for oxytocin needed oxytocin	116 participants n=5 Participants
Need for oxytocin did not need oxytocin	84 participants n=5 Participants
Outcome of induction of labor successful vaginal delivery	114 participants n=5 Participants
Outcome of induction of labor need for cesarean section	86 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

median cervical length measured by transvaginal ultrasound in centimetres

Outcome measures

Measure	Induction of Labor n=200 Participants 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
Cervical Length Prior to Labor Induction successful induction of labor	2.9 centimetres Interval 2.8 to 3.1
Cervical Length Prior to Labor Induction failed induction of labor	3 centimetres Interval 2.8 to 3.2

PRIMARY outcome

Timeframe: 72 hours

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.

Outcome measures

Measure	Induction of Labor n=200 Participants 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
Bishop Score Prior to Induction of Labor successful induction of labor	4 units on a scale Interval 3.0 to 5.0
Bishop Score Prior to Induction of Labor failed induction of labor	3 units on a scale Interval 3.0 to 4.0

Adverse Events

Induction of Labor

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Induction of Labor n=200 participants at risk 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
Pregnancy, puerperium and perinatal conditions low APGAR score	5.0% 10/200 • Number of events 10 • All participants and their livebirths were followed for 72 hours following delivery for adverse events
Pregnancy, puerperium and perinatal conditions low birth weight	0.50% 1/200 • Number of events 1 • All participants and their livebirths were followed for 72 hours following delivery for adverse events
Pregnancy, puerperium and perinatal conditions neonatal ICU admission	2.5% 5/200 • Number of events 5 • All participants and their livebirths were followed for 72 hours following delivery for adverse events
Pregnancy, puerperium and perinatal conditions maternal traumatic birth injury	1.5% 3/200 • Number of events 3 • All participants and their livebirths were followed for 72 hours following delivery for adverse events

Additional Information

amr ahmed mahmoud riad

Ain Shams Maternity hospital

Phone: 01005347179

Email: amr.riad@med.asu.edu.eg

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place