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

NCT04301388 | Withdrawn

• 1 other identifier: OBG-2562-06699
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Preterm Delivery Within 7 Day After Admission

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The number of tocolysis courses, length of hospital stay

  From admission to no uterine contraction in 10 minute

• The number of steroid courses

  From admission to no uterine contraction in 10 minute

Study Arms (2)

TVCL-based

EXPERIMENTAL

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

Procedure: Transvaginal ultrasound

Conventional-based

ACTIVE COMPARATOR

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

Procedure: Transvaginal ultrasound

Interventions

Transvaginal ultrasound PROCEDURE

Transvaginal ultrasound to measure cervical length if persist regular uterine contraction

Conventional-based; TVCL-based

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study in pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• /7 - 33 6/7 weeks of gestation
• Uneventful antenatal care or low-risk pregnancies

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (2)

Kuntharee Traisrisilp

Chiang Mai, 50200, Thailand

Location

Maharaj Nakorn ChiangMai Hospital

Chiang Mai, 50200, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: January 22, 2020
• Primary Completion: May 4, 2020
• Study Completion: January 1, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)