CervixNCT03034434
Cervical Recuperation After Vaginal Delivery
An observational study of Cervix, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Patients after vaginal delivery will undergo 3 trans-vaginal ultrasounds in order to examine the process of cervical recuperation post delivery. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervix
- What is being tested?
- Trans-vaginal ultrasound
- Type of treatment
- Medical device
- How many people
- 1,384 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Mar 2017to 30 Jun 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients after vaginal delivery.
Who may be able to join
- Any patient after vaginal delivery.
Who cannot join
- Any patient after cesarean section.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 8 hours post delivery.
- 24 hours post delivery.
- 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.
- Conditions
- Cervix
- Being tested
- Trans-vaginal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients after vaginal delivery | Patients after vaginal delivery willing to undergo 3 trans-vaginal ultrasounds within the 48 hours after delivery. Receives: Device: Trans-vaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical length after vaginal delivery.
Measurement of cervical length 8, 24, 48 hours after vaginal delivery by trans-vaginal ultrasound.
Measured: Up to 48 hours post delivery.
Secondary outcomes (1)
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.
Measured: Up to 48 hours post delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start14 Mar 2017
- Primary completion29 Feb 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CervixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,384 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034434
- Sponsor's protocol ID
- 0154-16-RMB
- Status last verified
- Jul 2020
- First submitted
- 25 Jan 2017
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36265677
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonography Evaluation of Cervical Recuperation After Vaginal Delivery
- ClinicalTrials.gov ID
- NCT03034434
- Acronym / sponsor ID
- 0154-16-RMB
- Conditions
- Cervix
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,384 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients after vaginal delivery will undergo 3 trans-vaginal ultrasounds in order to examine the process of cervical recuperation post delivery.
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:
- 8 hours post delivery.
- 24 hours post delivery.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after vaginal delivery | – | Device: Trans-vaginal ultrasoundPatients after vaginal delivery willing to undergo 3 trans-vaginal ultrasounds within the 48 hours after delivery. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients after vaginal delivery.
Key inclusion criteria (1 listed)
- Any patient after vaginal delivery.
Key exclusion criteria (1 listed)
- Any patient after cesarean section.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-vaginal ultrasoundThree 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. | Device | Patients after vaginal delivery |
Primary outcome
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.
1 secondary outcome
Differences in cervical length after vaginal delivery.
Time frame: Up to 48 hours post delivery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Derived from this study: PubMed 36265677Lauterbach 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.
- Individual participant dataSharing planned: Undecided
Related trials for Cervix
Not yet recruitingObservational study
Immunotherapy in Neuroendocrine Carcinoma of the Cervix
Cervical Neuroendocrine Carcinoma
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 4
Azithromycin for Cerclage Prophylaxis
Cervical Insufficiency
RecruitingObservational study
International PPB/DICER1 Registry
Pleuropulmonary Blastoma, Sertoli-Leydig Cell Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Lauterbach, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervix, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical length after vaginal delivery. (time frame: Up to 48 hours post delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03034434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.