NCT03034434

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,384

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 14, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

3 years

First QC Date

January 25, 2017

Last Update Submit

July 24, 2020

Conditions

Cervix

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Differences in cervical length after vaginal delivery.

    Up to 48 hours post delivery.

Study Arms (1)

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

Interventions

Trans-vaginal ultrasoundDEVICE

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.

Patients after vaginal delivery

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients only.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients after vaginal delivery.

You may qualify if:

  • Any patient after vaginal delivery.

You may not qualify if:

  • Any patient after cesarean section.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

Related Publications (1)

  • Lauterbach R, Bachar G, Ben-David C, Justman N, Siegler Y, Tzur L, Copel JA, Weiner Z, Beloosesky R, Ginsberg Y. Postpartum cervical length as a predictor of subsequent preterm birth-novel insights on an old enigma. Am J Obstet Gynecol. 2023 Apr;228(4):461.e1-461.e8. doi: 10.1016/j.ajog.2022.10.012. Epub 2022 Oct 18.

    PMID: 36265677DERIVED

Study Officials

  • Roy Lauterbach, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 25, 2017

First Posted

January 27, 2017

Study Start

March 14, 2017

Primary Completion

February 29, 2020

Study Completion

June 30, 2020

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations

IL(1)