Pregnancy, ProlongedNCT02680093
Birth Rate in Conservative Monitoring of Pregnancy Beyond the Date of Birth.
An observational study of Pregnancy, Prolonged, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Pregnant Women beyond the date of birth. will be followed while coming to routine monitoring. physiological parameter of cervical length will be measured as the differential predictor to determine their due date. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Prolonged
- What is being tested?
- Cervical length in pregnant women.
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jan 2018
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant Women beyond the date of birth in conservative monitoring and prenatal follow-up.
Who may be able to join
- Age 18-50 .
- Individual fetus
- The dating of gestational age based on first- trimester ultrasonography or by last menstrual
- Gestational age between 39 weeks and 0 days to 41 weeks and 6 days .
- The pregnant women is not in pain ( VAS <3 ) while signing on consent to participate.
- Normal fetal monitoring measures and Sonar
- Expectant mother is in active labor
- Consent to participate
Who cannot join
- Multi-pass Pregnancy
- Without accurate dating of gestational age based on first- trimester ultrasonography or by last menstrual
- Indicators for abnormal fetal monitoring and / or Sonar
- Active labor
- pain ( VAS > = 3 )
- Expectant mother does not agree to participate or delivery if consent was given earlier
Trial locations and contacts
No sites are listed yet.
About this study
Pregnant Women beyond the date of birth. will be followed while coming to routine monitoring. physiological parameter of cervical length will be measured as the differential predictor to determine their due date. the cervical length will be measured as part of routine gynecologic examination to women who come for routine over due date follow up.
additional medical data will be collected from the patient medical record.- demographic data, and all the routine prenatal medical care the women will receive up to the delivery.and delivery outcomes.
Read the detailed description
The clinical part of the study: the first visit of pregnancy monitoring is carried out at 40 full weeks. First visit to make sure the gestational age to receive full medical anamnesis , perform physical examination and vaginal and NST and BPP. Also, assess the clinical weight and when the need arises assessment of weight sonography. monitoring fetal movements . The women are ordered to return for routine check ups every 3 days. from - 41 full weeks the women should come every two days and 42 weeks should be referred for induction. In practice, the women offered induction at 41 weeks + 3 or 4 days.
- Conditions
- Pregnancy, Prolonged
- Being tested
- Cervical length in pregnant women.
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical length in pregnant women.Other
Pregnant Women beyond the date of birth. will be followed while coming to routine monitoring. physiological parameter of cervical length will be measured as the differential predictor to determine their due date. the cervical length will be measured as part of routine gynecologic examination to women who come for routine over due date follow up.
additional medical data will be collected from the patient medical record.- demographic data, and all the routine prenatal medical care the women will receive up to the delivery.and delivery out comes.
| Study group | Role | What they receive |
|---|---|---|
| Cervical length in pregnant women. | Pregnant Women beyond the date of birth in conservative monitoring and prenatal follow-up. will be followed while coming to routine monitoring.
physiological parameter of cervical length will be measured as the differential predictor to determine their due date. Receives: Other: Cervical length in pregnant women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time interval between measurement of cervical length and delivery
According to our local protocol post date surveillance is stated from 40+0 weeks of gestation. Each gravida undergoes vaginal examination using sonographic measurement of cervical length(in mm) using trans-vaginal sonar.
Measured: 2 weeks.
Secondary outcomes (3)
Delivery with in 48 hours
Measured: 48 hours
Delivery with in 7 days
Measured: 7 days
Necessity of labor induction duo to post date
yes or no. documenting what kind of induction performed.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, ProlongedStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- yariv yogev, professor, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680093
- Sponsor's protocol ID
- 0602-15
- Status last verified
- Feb 2016
- First submitted
- 21 Jan 2016
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Birth Rate in Conservative Monitoring of Pregnancy Beyond the Date of Birth.
- ClinicalTrials.gov ID
- NCT02680093
- Acronym / sponsor ID
- 0602-15
- Conditions
- Pregnancy, Prolonged
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Feb 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 11 Feb 2016 (estimated)
- 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.
Pregnant Women beyond the date of birth. will be followed while coming to routine monitoring. physiological parameter of cervical length will be measured as the differential predictor to determine their due date. the cervical length will be measured as part of routine gynecologic examination to women who come for routine over due date follow up.
additional medical data will be collected from the patient medical record.- demographic data, and all the routine prenatal medical care the women will receive up to the delivery.and delivery outcomes.
Detailed description
The clinical part of the study: the first visit of pregnancy monitoring is carried out at 40 full weeks. First visit to make sure the gestational age to receive full medical anamnesis , perform physical examination and vaginal and NST and BPP. Also, assess the clinical weight and when the need arises assessment of weight sonography. monitoring fetal movements . The women are ordered to return for routine check ups every 3 days. from - 41 full weeks the women should come every two days and 42 weeks should be referred for induction. In practice, the women offered induction at 41 weeks + 3 or 4 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical length in pregnant women. | – | Other: Cervical length in pregnant women.Pregnant Women beyond the date of birth in conservative monitoring and prenatal follow-up. will be followed while coming to routine monitoring. physiological parameter of cervical length will be measured as the differential predictor to determine their due date. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant Women beyond the date of birth in conservative monitoring and prenatal follow-up.
Key inclusion criteria (8 listed)
- Age 18-50 .
- Individual fetus
- The dating of gestational age based on first- trimester ultrasonography or by last menstrual
- Gestational age between 39 weeks and 0 days to 41 weeks and 6 days .
- The pregnant women is not in pain ( VAS <3 ) while signing on consent to participate.
Key exclusion criteria (6 listed)
- Multi-pass Pregnancy
- Without accurate dating of gestational age based on first- trimester ultrasonography or by last menstrual
- Indicators for abnormal fetal monitoring and / or Sonar
- Active labor
- pain ( VAS > = 3 )
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 |
|---|---|---|
| Cervical length in pregnant women.Pregnant Women beyond the date of birth. will be followed while coming to routine monitoring. physiological parameter of cervical length will be measured as the differential predictor to determine their due date. the cervical length will be measured as part of routine gynecologic examination to women who come for routine over due date follow up. additional medical data will be collected from the patient medical record.- demographic data, and all the routine prenatal medical care the women will receive up to the delivery.and delivery out comes. | Other | Cervical length in pregnant women. |
Primary outcome
Time interval between measurement of cervical length and delivery
Time frame: 2 weeks.
According to our local protocol post date surveillance is stated from 40+0 weeks of gestation. Each gravida undergoes vaginal examination using sonographic measurement of cervical length(in mm) using trans-vaginal sonar.
3 secondary outcomes
Delivery with in 48 hours
Time frame: 48 hours
Delivery with in 7 days
Time frame: 7 days
Necessity of labor induction duo to post date
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
- Individual participant dataSharing planned: No
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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.
yariv yogev, professor principal investigator
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, Prolonged, run by Tel-Aviv Sourasky Medical Center.
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 8 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 11 Feb 2016. 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 yariv yogev, professor (97236925603, yarivy@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time interval between measurement of cervical length and delivery (time frame: 2 weeks.). 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 11 Feb 2016.