- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02680093
Birth Rate in Conservative Monitoring of Pregnancy Beyond the Date of Birth.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delivery with in 48 hours
Time Frame: 48 hours
|
48 hours
|
|
|
Delivery with in 7 days
Time Frame: 7 days
|
7 days
|
|
|
Necessity of labor induction duo to post date
Time Frame: 2 weeks
|
yes or no.
documenting what kind of induction performed.
|
2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0602-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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