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Cervical Recuperation After Vaginal Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03034434
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
ROY LAUTERBACH MD, Rambam Health Care Campus

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

Condition or disease Intervention/treatment
Cervix 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1384 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Sonography Evaluation of Cervical Recuperation After Vaginal Delivery
Actual Study Start Date : March 14, 2017
Actual Primary Completion Date : February 29, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




Primary Outcome Measures :
  1. Cervical length after vaginal delivery. [ Time Frame: Up to 48 hours post delivery. ]
    Measurement of cervical length 8, 24, 48 hours after vaginal delivery by trans-vaginal ultrasound.


Secondary Outcome Measures :
  1. Differences in cervical length after vaginal delivery. [ Time Frame: Up to 48 hours post delivery. ]
    Differences in cervical length after vaginal delivery as a factor of gestational age at delivery, means of labor induction, parity, etc.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients only.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients after vaginal delivery.
Criteria

Inclusion Criteria:

  • Any patient after vaginal delivery.

Exclusion Criteria:

  • Any patient after cesarean section.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034434


Locations
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Israel
Rambam health care campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Roy Lauterbach, MD Rambam Health Care Campus
Additional Information:

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Responsible Party: ROY LAUTERBACH MD, Principal investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03034434    
Other Study ID Numbers: 0154-16-RMB
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No