Cervical Recuperation After Vaginal Delivery

Cervix Clinical Trial

Official title:

Sonography Evaluation of Cervical Recuperation After Vaginal Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034434
• Other study ID #: 0154-16-RMB
• Status: Completed
• Start date: March 14, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Patients after vaginal delivery will undergo 3 trans-vaginal ultrasounds in order to examine the process of cervical recuperation post delivery.

Description:

Patients after vaginal delivery will be recruited after receiving a full explanation and signing an informed consent.

The goal of the study is to examine cervical length after vaginal delivery at 3 different time intervals:

1. 8 hours post delivery.

2. 24 hours post delivery.

3. 48 hours post delivery. At each interval a trans-vaginal ultrasound will be performed, evaluating cervical length. At the end of the 3rd and final ultrasound, the patient will finish her participation in the study/ Information regarding obstetric conditions such as labor induction, gestational age at the time of delivery etc. will be collected from patients` electronic files.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1384
• Est. completion date: June 30, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Any patient after vaginal delivery.

Exclusion Criteria:

• Any patient after cesarean section.

Related Conditions & MeSH terms

• Cervix

Intervention

Device:
• Trans-vaginal ultrasound
Three trans-vaginal ultrasounds, the 1st to be performed 8 hours post delivery, the 2nd 24 hours after delivery and the 3rd 48 hours after delivery.

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical length after vaginal delivery.	Measurement of cervical length 8, 24, 48 hours after vaginal delivery by trans-vaginal ultrasound.	Up to 48 hours post delivery.
Secondary	Differences in cervical length after vaginal delivery.	Differences in cervical length after vaginal delivery as a factor of gestational age at delivery, means of labor induction, parity, etc.	Up to 48 hours post delivery.