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Cervical Recuperation After Vaginal Delivery

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ClinicalTrials.gov Identifier: NCT03034434
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : June 11, 2019
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]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Sonography Evaluation of Cervical Recuperation After Vaginal Delivery
Actual Study Start Date : March 14, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 31, 2019

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


Contacts
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Contact: Roy Lauterbach, MD 0529432416 r_lauterbach@rambam.health.gov.il
Contact: Yuval Ginsberg, MD 0523571199 y_ginsberg@rambam.health.gov.il

Locations
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Israel
Rambam health care campus Recruiting
Haifa, Israel
Contact: Roy Lauterbach, MD    0529432416    r_lauterbach@rambam.health.gov.il   
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     History of Changes
Other Study ID Numbers: 0154-16-RMB
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
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