Back to resultsManagement of Threatened Preterm Labor by Cervical Length-based Approach or Conventional Approach
Primary Purpose
Preterm Delivery Within 7 Day After Admission
Status
Withdrawn
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Transvaginal ultrasound
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Delivery Within 7 Day After Admission
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Kuntharee Traisrisilp
- Maharaj Nakorn ChiangMai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TVCL-based
Conventional-based
Arm Description
Monitor progression of labor by shortening of cervix examined by transvaginal cervical length
Monitor progression of labor by per vaginal exam to detect cervical change
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The number of tocolysis courses, length of hospital stay
In case of tocolytic used for stop labor. The number of medication will be recorded.
The number of steroid courses
In case of stop labor, the course of steroid for promote lung maturity is recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04301388
Brief Title
Management of Threatened Preterm Labor by Cervical Length-based Approach or Conventional Approach
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why 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.
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
May 4, 2020 (Actual)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ChaingMai University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the effectiveness of treatment of threatened preterm labor between transvaginal cervical length-based approach and conventional approach (Per vaginal examination)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Delivery Within 7 Day After Admission
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TVCL-based
Arm Type
Experimental
Arm Description
Monitor progression of labor by shortening of cervix examined by transvaginal cervical length
Arm Title
Conventional-based
Arm Type
Active Comparator
Arm Description
Monitor progression of labor by per vaginal exam to detect cervical change
Intervention Type
Procedure
Intervention Name(s)
Transvaginal ultrasound
Intervention Description
Transvaginal ultrasound to measure cervical length if persist regular uterine contraction
Primary Outcome Measure Information:
Title
Number of cases with delivery within 7 day after admission
Description
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.
Time Frame
From admission to no uterine contraction in 10 minute
Secondary Outcome Measure Information:
Title
The number of tocolysis courses, length of hospital stay
Description
In case of tocolytic used for stop labor. The number of medication will be recorded.
Time Frame
From admission to no uterine contraction in 10 minute
Title
The number of steroid courses
Description
In case of stop labor, the course of steroid for promote lung maturity is recorded.
Time Frame
From admission to no uterine contraction in 10 minute
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Study in pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Facility Information:
Facility Name
Kuntharee Traisrisilp
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Maharaj Nakorn ChiangMai Hospital
City
ChiangMai
ZIP/Postal Code
50200
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Management of Threatened Preterm Labor by Cervical Length-based Approach or Conventional Approach
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