Preterm Delivery Within 7 Day After AdmissionNCT04301388
Management of Threatened Preterm Labor by Cervical Length-based Approach or Conventional Approach
A study testing Transvaginal ultrasound in people with Preterm Delivery Within 7 Day After Admission, run by Chiang Mai University at 2 sites in Thailand.
Trial summary
To compare the effectiveness of treatment of threatened preterm labor between transvaginal cervical length-based approach and conventional approach (Per vaginal examination) Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Delivery Within 7 Day After Admission
- What is being tested?
- Transvaginal ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesThailand
- Study dates
- 22 Jan 2020to Jan 2021
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant with symptoms of threatened preterm labor which refer to regular uterine contractions at least 1 time in every 10 minutes and persist for 30 minute without cervical dilatation or cervical dilation ≤ 1 cm and < 80% of effacement.
- Age ≥ 18 years
- Singleton pregnancy
- 24 0/7 - 33 6/7 weeks of gestation
- Uneventful antenatal care or low-risk pregnancies
Who cannot join
- The definitive diagnosis of true labor
- Proceed to the active phase of labor
- Age < 18 years
- Multiple pregnancies
- < 24 or ≥ 34 weeks of gestation
- Fetal chromosomal or structural abnormalities
Show all 15Show fewer
- Abnormal fetal growth
- Abnormal amniotic fluid
- Evidence of placenta previa
- Significant vaginal bleeding that cannot be ruled out placenta previa
- Evidence of rupture of membranes
- Evidence of intrauterine infection
- Evidence of uterine malformation
- Evidence of lethal fetal malformation
- Unable to communicate or understand the information of the study
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Kuntharee Traisrisilp
Chiang Mai, 50200
Maharaj Nakorn ChiangMai Hospital
Chiang Mai, 50200
About this study
Official title: A Comparison of the Effectiveness in Management of Threatened Preterm Labor Between Cervical Length-based Approach and Conventional Approach: A Randomized Control Trial
To compare the effectiveness of treatment of threatened preterm labor between transvaginal cervical length-based approach and conventional approach (Per vaginal examination)
- Being tested
- Transvaginal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasoundProcedure or surgery
Transvaginal ultrasound to measure cervical length if persist regular uterine contraction
| Study group | Role | What they receive |
|---|---|---|
| TVCL-based | Experimental | Monitor progression of labor by shortening of cervix examined by transvaginal cervical length Receives: Procedure: Transvaginal ultrasound |
| Conventional-based | Active comparator | Monitor progression of labor by per vaginal exam to detect cervical change Receives: Procedure: Transvaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases with delivery within 7 day after admission
In case of threatened preterm labor if detection the progression of labor by transvaginal cervical length, the rate of delivery within 7 days will less or more than conventional group.
Measured: From admission to no uterine contraction in 10 minute
Secondary outcomes (2)
The number of tocolysis courses, length of hospital stay
In case of tocolytic used for stop labor. The number of medication will be recorded.
Measured: From admission to no uterine contraction in 10 minute
The number of steroid courses
In case of stop labor, the course of steroid for promote lung maturity is recorded.
Measured: From admission to no uterine contraction in 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start22 Jan 2020
- Primary completion4 May 2020
- Study completionJan 2021 (estimated)
Why it stopped: We unable to include the participants as we expected. Only 1 case included after 4 months of recruitment so we decided to withdrawn the study. This is because of COVID-19 pandemic, result in decreasing in the number of patient visiting our insitute.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Delivery Within 7 Day After AdmissionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuntharee Traisrisilp, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301388
- Sponsor's protocol ID
- OBG-2562-06699
- Status last verified
- Aug 2021
- First submitted
- 6 Mar 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effectiveness in Management of Threatened Preterm Labor Between Cervical Length-based Approach and Conventional Approach: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04301388
- Acronym / sponsor ID
- OBG-2562-06699
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We unable to include the participants as we expected. Only 1 case included after 4 months of recruitment so we decided to withdrawn the study. This is because of COVID-19 pandemic, result in decreasing in the number of patient visiting our insitute.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- Jan 2021 (estimated)
- First posted
- 10 Mar 2020 (actual)
- 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.
To compare the effectiveness of treatment of threatened preterm labor between transvaginal cervical length-based approach and conventional approach (Per vaginal examination)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TVCL-based | Experimental | Procedure: Transvaginal ultrasoundMonitor progression of labor by shortening of cervix examined by transvaginal cervical length |
| Conventional-based | Active comparator | Procedure: Transvaginal ultrasoundMonitor progression of labor by per vaginal exam to detect cervical change |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant with symptoms of threatened preterm labor which refer to regular uterine contractions at least 1 time in every 10 minutes and persist for 30 minute without cervical dilatation or cervical dilation ≤ 1 cm and < 80% of effacement.
- Age ≥ 18 years
- Singleton pregnancy
- 24 0/7 - 33 6/7 weeks of gestation
- Uneventful antenatal care or low-risk pregnancies
Key exclusion criteria (15 listed)
- The definitive diagnosis of true labor
- Proceed to the active phase of labor
- Age < 18 years
- Multiple pregnancies
- < 24 or ≥ 34 weeks of gestation
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 |
|---|---|---|
| Transvaginal ultrasoundTransvaginal ultrasound to measure cervical length if persist regular uterine contraction | Procedure or surgery | Conventional-based, TVCL-based |
Primary outcome
Number of cases with delivery within 7 day after admission
Time frame: From admission to no uterine contraction in 10 minute
In case of threatened preterm labor if detection the progression of labor by transvaginal cervical length, the rate of delivery within 7 days will less or more than conventional group.
2 secondary outcomes
The number of tocolysis courses, length of hospital stay
Time frame: From admission to no uterine contraction in 10 minute
The number of steroid courses
Time frame: From admission to no uterine contraction in 10 minute
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal ultrasound in people with Preterm Delivery Within 7 Day After Admission, run by Chiang Mai University at 2 sites in Thailand.
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 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of cases with delivery within 7 day after admission (time frame: From admission to no uterine contraction in 10 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2021.