NCT03113227

Brief Summary

Seventy ladies indicated for induction of delivery will be recruited. Two ways of assessment of their cervices will be done before actual induction of labor. First, ultrasound will be done to assess the angle and the length of the cervix. Then vaginal examination will be done to assess the characteristics of cervix. Analysis will be done to identify the best predictor of successful induction of labour.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

April 15, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2017

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

April 10, 2017

Last Update Submit

July 13, 2017

Conditions

Induced; Birth

Keywords

induction of laborBishop scoreposterior cervical anglecervical length

Outcome Measures

Primary Outcomes (1)

  • Value of posterior cervical angle

    Value of posterior cervical angle will be measured by an investigator

    At around 10 minutes from admission to hospital

Secondary Outcomes (2)

  • Length of the cervix

    At around 10 minutes from admission to hospital

  • Bishop score

    At around 30 minutes from admission to hospital

Study Arms (2)

Successful Induction of labor group

ACTIVE COMPARATOR

Both transvaginal ultrasound and vaginal examination will be done for that group

Diagnostic Test: Transvaginal ultrasoundDiagnostic Test: Vaginal examination

Failed induction of labor group

ACTIVE COMPARATOR

Both transvaginal ultrasound and vaginal examination will be done for that group

Diagnostic Test: Transvaginal ultrasoundDiagnostic Test: Vaginal examination

Interventions

Transvaginal ultrasoundDIAGNOSTIC_TEST

Transvaginal ultrasound will be made for assessment of posterior cervical angle and cervical length

Failed induction of labor groupSuccessful Induction of labor group
Vaginal examinationDIAGNOSTIC_TEST

Vaginal examination will be done for assessment of Bishop score

Failed induction of labor groupSuccessful Induction of labor group

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy
  • Gestational age between 35 and 42
  • Presence of an indication for induction of labour as post-term pregnancy or rupture of membranes
  • The fetus is living
  • Cephalic presentation

You may not qualify if:

  • Estimated fetal weight more than 4 kilograms
  • Malpresentation
  • Oligohydramnios
  • Polyhydramnios
  • Non-reassuring non-stress test before induction of labor
  • Cephalo-pelvic disproportion
  • Previous operation on the cervix as cautery or cerclage
  • Previous cesarean section
  • Any contraindication to vaginal delivery including placenta previa
  • Anomalous fetus
  • Morbid obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Cairo, Greater Cairo, 11956, Egypt

Location

Related Publications (1)

  • Al-Adwy AM, Sobh SM, Belal DS, Omran EF, Hassan A, Saad AH, Afifi MM, Nada AM. Diagnostic accuracy of posterior cervical angle and cervical length in the prediction of successful induction of labor. Int J Gynaecol Obstet. 2018 Apr;141(1):102-107. doi: 10.1002/ijgo.12425. Epub 2018 Jan 18.

    PMID: 29224196DERIVED

MeSH Terms

Interventions

Gynecological Examination

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Eman Omran, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 13, 2017

Study Start

April 15, 2017

Primary Completion

July 9, 2017

Study Completion

July 9, 2017

Last Updated

July 17, 2017

Record last verified: 2017-07

Locations

EG(1)