Cervical Gland Area as a Predictor of Success of Labour Induction
- Conditions
- Induced Vaginal Delivery
- Registration Number
- NCT04416022
- Lead Sponsor
- Rambam Health Care Campus
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- 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)
- Intrauterine fetal demise (IUFD)
- Contraindication to vaginal delivery
- Status post cervical cerclage
- Previous attempt of labor induction
- History of cervical surgery
- Active vaginal bleeding
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Onset of active labour Up to delivery Percent of patients that reached the active stage of labour (defined as measurement of cervical dilation of greater than 6 cm)
- Secondary Outcome Measures
Name Time Method Rate of vaginal delivery Up to delivery The rate of patient that deliver vaginally including instrumental deliverires
Time from Induction to delivery Up to delivery Duration of time from initiation of labpur induction to delivery
Neonatal outcome - PH Up to 10 minutes from delivery The fetal arterial pH measuerment following the delivery
Neonatal outcome - APGAR (Apearance, Pulse, Grimace, Activity, Respiration score) Up to 5 minutes from delivery The fetal APGAR score as recieved by pediatrician
Time from Induction to second stage Up to delivery Duration of time from initiation of labpur induction to cervical dilation of 10cm
Neonatal outcome - NICU (Neonatal Intensive Care Unit) admission Up to 48 hours from delivery Percent of neonated that requiered NICU admission