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

Chiang Mai University

Status: Withdrawn

Conditions: Preterm Delivery Within 7 Day After Admission

Treatments: Procedure: Transvaginal ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04301388

OBG-2562-06699

Details and patient eligibility

About

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

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

TVCL-based

Experimental group

Description:

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

Treatment:

Procedure: Transvaginal ultrasound

Conventional-based

Active Comparator group

Description:

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

Treatment:

Procedure: Transvaginal ultrasound