Induced Vaginal DeliveryNCT04416022
Cervical Gland Area as a Predictor of Success of Labour Induction
An observational study of Induced Vaginal Delivery, run by Rambam Health Care Campus.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Vaginal Delivery
- What is being tested?
- Ultrasound examination
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 7 Jun 2020to 7 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women who are planned form labour induction
Who may be able to join
- 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)
Who cannot join
- Intrauterine fetal demise (IUFD)
- Contraindication to vaginal delivery
- Status post cervical cerclage
- Previous attempt of labor induction
- History of cervical surgery
- Active vaginal bleeding
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Induced Vaginal Delivery
- Being tested
- Ultrasound examination
- Keywords
- Labour induction, Cervical glandular area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examinationDiagnostic test
Women that are planned for labour induction, will undergo a routine ultrasound examination prior to the initiation of the induction process.
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of active labour
Percent of patients that reached the active stage of labour (defined as measurement of cervical dilation of greater than 6 cm)
Measured: Up to delivery
Secondary outcomes (6)
Time from Induction to second stage
Duration of time from initiation of labpur induction to cervical dilation of 10cm
Measured: Up to delivery
Time from Induction to delivery
Duration of time from initiation of labpur induction to delivery
Measured: Up to delivery
Rate of vaginal delivery
The rate of patient that deliver vaginally including instrumental deliverires
Measured: Up to delivery
Neonatal outcome - PH
The fetal arterial pH measuerment following the delivery
Measured: Up to 10 minutes from delivery
Neonatal outcome - APGAR (Apearance, Pulse, Grimace, Activity, Respiration score)
The fetal APGAR score as recieved by pediatrician
Measured: Up to 5 minutes from delivery
Neonatal outcome - NICU (Neonatal Intensive Care Unit) admission
Percent of neonated that requiered NICU admission
Measured: Up to 48 hours from delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start7 Jun 2020 (estimated)
- Primary completion7 Jun 2022 (estimated)
- Study completion7 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced Vaginal DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SAAR AHARONI MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416022
- Sponsor's protocol ID
- 0711-19-RMB
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Gland Area as a Predictor of Success of Labour Induction
- ClinicalTrials.gov ID
- NCT04416022
- Acronym / sponsor ID
- 0711-19-RMB
- Conditions
- Induced Vaginal Delivery
- Keywords
- Labour induction, Cervical glandular area
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 7 Jun 2020 (estimated)
- Primary completion
- 7 Jun 2022 (estimated)
- Study completion
- 7 Jun 2022 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women who are planned form labour induction
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- Intrauterine fetal demise (IUFD)
- Contraindication to vaginal delivery
- Status post cervical cerclage
- Previous attempt of labor induction
- History of cervical surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound examinationWomen that are planned for labour induction, will undergo a routine ultrasound examination prior to the initiation of the induction process. | Diagnostic test | – |
Primary outcome
Onset of active labour
Time frame: Up to delivery
Percent of patients that reached the active stage of labour (defined as measurement of cervical dilation of greater than 6 cm)
6 secondary outcomes
Time from Induction to second stage
Time frame: Up to delivery
Time from Induction to delivery
Time frame: Up to delivery
Rate of vaginal delivery
Time frame: Up to delivery
Neonatal outcome - PH
Time frame: Up to 10 minutes from delivery
Neonatal outcome - APGAR (Apearance, Pulse, Grimace, Activity, Respiration score)
Time frame: Up to 5 minutes from delivery
Neonatal outcome - NICU (Neonatal Intensive Care Unit) admission
Time frame: Up to 48 hours from delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Induced Vaginal Delivery
Not yet recruiting
Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy
Induced; Birth
Recruiting
Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)
Nulliparous Women Who Scheduled for Labor Induction, Pregnancy
Not yet recruiting
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal Trauma, Postpartum Pain
Active, not recruiting
Comparison of Vaginal PGE2 (Dinoprostone) and Vaginal Misoprostol for Induction of Labour in Primigravid Term Pregnancy
Labor, Induced, Term Pregnancy
Recruiting
PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)
Premature Rupture of Fetal Membranes, Labor, Induced
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Induced Vaginal Delivery, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saar Aharoni, M.D (+ 523395351, s_aharoni@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of active labour (time frame: Up to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.