Management of Threatened Preterm Labor by Cervical Length-based Approach or Conventional Approach
Not Applicable
Withdrawn
- Conditions
- Preterm Delivery Within 7 Day After Admission
- Interventions
- Procedure: Transvaginal ultrasound
- Registration Number
- NCT04301388
- Lead Sponsor
- Chiang Mai University
- Brief Summary
To compare the effectiveness of treatment of threatened preterm labor between transvaginal cervical length-based approach and conventional approach (Per vaginal examination)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TVCL-based Transvaginal ultrasound Monitor progression of labor by shortening of cervix examined by transvaginal cervical length Conventional-based Transvaginal ultrasound Monitor progression of labor by per vaginal exam to detect cervical change
- Primary Outcome Measures
Name Time Method Number of cases with delivery within 7 day after admission 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.
- Secondary Outcome Measures
Name Time Method The number of tocolysis courses, length of hospital stay From admission to no uterine contraction in 10 minute In case of tocolytic used for stop labor. The number of medication will be recorded.
The number of steroid courses From admission to no uterine contraction in 10 minute In case of stop labor, the course of steroid for promote lung maturity is recorded.
Trial Locations
- Locations (2)
Maharaj Nakorn ChiangMai Hospital
🇹🇭ChiangMai, Thailand
Kuntharee Traisrisilp
🇹🇭Chiang Mai, Thailand