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

• Sponsor: ChaingMai University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04301388
• Collaborator: (none)
• Enrollment: 0
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 11.3
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Preterm Delivery Within 7 Day After Admission	Procedure: Transvaginal ultrasound	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Comparison of the Effectiveness in Management of Threatened Preterm Labor Between Cervical Length-based Approach and Conventional Approach: A Randomized Control Trial
• Actual Study Start Date: Jan 22, 2020
• Actual Primary Completion Date: May 4, 2020
• Anticipated Study Completion Date: Jan 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kuntharee Traisrisilp	Chiang Mai		Thailand	50200
2	Maharaj Nakorn ChiangMai Hospital	ChiangMai		Thailand	50200

Sponsors and Collaborators

• ChaingMai University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kuntharee Traisrisilp, Assistant professor, ChaingMai University
• ClinicalTrials.gov Identifier: NCT04301388
• Other Study ID Numbers: OBG-2562-06699
• First Posted: Mar 10, 2020
• Last Update Posted: Aug 9, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Premature Birth; Obstetric Labor, Premature

Study Results

No Results Posted as of Aug 9, 2021