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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Preterm Delivery Within 7 Day After Admission
• Intervention / Treatment: Procedure: Transvaginal ultrasound

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Kuntharee Traisrisilp
  • ChiangMai, Thailand, 50200
    • Maharaj Nakorn Chiangmai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TVCL-based; Monitor progression of labor by shortening of cervix examined by transvaginal cervical length	Procedure: Transvaginal ultrasound; Transvaginal ultrasound to measure cervical length if persist regular uterine contraction
ACTIVE_COMPARATOR: Conventional-based; Monitor progression of labor by per vaginal exam to detect cervical change	Procedure: Transvaginal ultrasound; Transvaginal ultrasound to measure cervical length if persist regular uterine contraction

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ChaingMai University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2020
• Primary Completion (ACTUAL): May 4, 2020
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (ACTUAL): March 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: OBG-2562-06699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No