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

Pregnancy, Prolonged Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02680093
• Other study ID #: 0602-15
• Status: Not yet recruiting
• Phase: N/A
• First received: January 21, 2016
• Last updated: February 8, 2016
• Start date: February 2016
• Est. completion date: January 2018

Study information

• Verified date: February 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: yariv yogev, professor
• Phone: 97236925603
• Email: yarivy[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy, Prolonged

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks.	No
Secondary	Delivery with in 48 hours		48 hours	No
Secondary	Delivery with in 7 days		7 days	No
Secondary	Necessity of labor induction duo to post date	yes or no. documenting what kind of induction performed.	2 weeks	No