Cervical Recuperation After Vaginal Delivery

Sonography Evaluation of Cervical Recuperation After Vaginal Delivery

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

Study Overview

• Status: Completed
• Conditions: Cervix
• Intervention / Treatment: Device: Trans-vaginal ultrasound

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1384

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients after vaginal delivery.

Description

Inclusion Criteria:

• Any patient after vaginal delivery.

Exclusion Criteria:

• Any patient after cesarean section.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients after vaginal delivery; Patients after vaginal delivery willing to undergo 3 trans-vaginal ultrasounds within the 48 hours after delivery.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2017
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 0154-16-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No