Management of Threatened Preterm Labor by Cervical Length-based Approach or Conventional Approach

Study Overview
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Brief Summary
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To compare the effectiveness of treatment of threatened preterm labor between transvaginal cervical length-based approach and conventional approach (Per vaginal examination)

Official Title
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A Comparison of the Effectiveness in Management of Threatened Preterm Labor Between Cervical Length-based Approach and Conventional Approach: A Randomized Control Trial

Conditions
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Preterm Delivery Within 7 Day After Admission

Intervention / Treatment
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* Procedure: Transvaginal ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TVCL-based<br>Monitor progression of labor by shortening of cervix examined by transvaginal cervical length | Procedure: Transvaginal ultrasound<br>* Transvaginal ultrasound to measure cervical length if persist regular uterine contraction<br>|
| Active Comparator: Conventional-based<br>Monitor progression of labor by per vaginal exam to detect cervical change | Procedure: Transvaginal ultrasound<br>* Transvaginal ultrasound to measure cervical length if persist regular uterine contraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From admission to no uterine contraction in 10 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of tocolysis courses, length of hospital stay | In case of tocolytic used for stop labor. The number of medication will be recorded. | 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. | From admission to no uterine contraction in 10 minute |