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Cervical Gland Area as a Predictor of Success of Labour Induction

Cervical Gland Area as a Predictor of Success of Labour Induction

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04416022
Enrollment
100
Registered
2020-06-04
Start date
2020-06-07
Completion date
2022-06-07
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induced Vaginal Delivery

Keywords

Labour induction, Cervical glandular area

Brief summary

Women who fulfil the inclusion criteria and who are planned for labour induction will be recruited. Bishop score, cervical length, and the presence of cervical glandular area (CGA) will be documented for every patient up to 12 hours prior to the induction process, and patient information and maternal and neonatal outcome will be documented following the delivery.

Detailed description

Patient consent to participate in the study will be retrieved following the medical decision of labor induction and the mode of induction and following the patient consent to the induction. Bishop score, cervical length, and the presence of cervical glandular area (CGA) will be documented for every patient up to 12 hours prior to the induction process. The method of induction, data regarding patient demographics, the progress of labor, and the maternal and neonatal outcome will be documented following the delivery.

Interventions

DIAGNOSTIC_TESTUltrasound examination

Women that are planned for labour induction, will undergo a routine ultrasound examination prior to the initiation of the induction process.

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Singleton and twins' pregnancies * Pregnancy 34-41 weeks of gestation * Vertex presentation * Induction methods (Oxytocin, prostaglandin 1 (PGE1), prostaglandin 2 (PGE2), double balloon catheter, rupture of memebrane (ROM)

Exclusion criteria

* Intrauterine fetal demise (IUFD) * Contraindication to vaginal delivery * Status post cervical cerclage * Previous attempt of labor induction * History of cervical surgery * Active vaginal bleeding

Design outcomes

Primary

MeasureTime frameDescription
Onset of active labourUp to deliveryPercent of patients that reached the active stage of labour (defined as measurement of cervical dilation of greater than 6 cm)

Secondary

MeasureTime frameDescription
Time from Induction to deliveryUp to deliveryDuration of time from initiation of labpur induction to delivery
Rate of vaginal deliveryUp to deliveryThe rate of patient that deliver vaginally including instrumental deliverires
Time from Induction to second stageUp to deliveryDuration of time from initiation of labpur induction to cervical dilation of 10cm
Neonatal outcome - APGAR (Apearance, Pulse, Grimace, Activity, Respiration score)Up to 5 minutes from deliveryThe fetal APGAR score as recieved by pediatrician
Neonatal outcome - NICU (Neonatal Intensive Care Unit) admissionUp to 48 hours from deliveryPercent of neonated that requiered NICU admission
Neonatal outcome - PHUp to 10 minutes from deliveryThe fetal arterial pH measuerment following the delivery

Contacts

Primary ContactSaar Aharoni, M.D
s_aharoni@rambam.health.gov.il+ 523395351

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026