Birth Rate in Conservative Monitoring of Pregnancy Beyond the Date of Birth.

February 8, 2016 updated by: Tel-Aviv Sourasky Medical Center

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

Unknown

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant Women beyond the date of birth in conservative monitoring and prenatal follow-up.

Description

Inclusion Criteria:

  1. Age 18-50 .
  2. Individual fetus
  3. The dating of gestational age based on first- trimester ultrasonography or by last menstrual
  4. Gestational age between 39 weeks and 0 days to 41 weeks and 6 days .
  5. The pregnant women is not in pain ( VAS <3 ) while signing on consent to participate.
  6. Normal fetal monitoring measures and Sonar
  7. Expectant mother is in active labor
  8. Consent to participate

Exclusion Criteria:

  1. Multi-pass Pregnancy
  2. Without accurate dating of gestational age based on first- trimester ultrasonography or by last menstrual
  3. Indicators for abnormal fetal monitoring and / or Sonar
  4. Active labor
  5. pain ( VAS > = 3 )
  6. Expectant mother does not agree to participate or delivery if consent was given earlier

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

February 8, 2016

First Posted (Estimate)

February 11, 2016

Study Record Updates

Last Update Posted (Estimate)

February 11, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

February 1, 2016

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)?

No

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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