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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2021-01-31

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)

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Detailed Description

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Conditions

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Preterm Delivery Within 7 Day After Admission

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TVCL-based

Monitor progression of labor by shortening of cervix examined by transvaginal cervical length

Group Type EXPERIMENTAL

Transvaginal ultrasound

Intervention Type PROCEDURE

Transvaginal ultrasound to measure cervical length if persist regular uterine contraction

Conventional-based

Monitor progression of labor by per vaginal exam to detect cervical change

Group Type ACTIVE_COMPARATOR

Transvaginal ultrasound

Intervention Type PROCEDURE

Transvaginal ultrasound to measure cervical length if persist regular uterine contraction

Interventions

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Transvaginal ultrasound

Transvaginal ultrasound to measure cervical length if persist regular uterine contraction

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes