Maternal Serum Homocysteine Levels and Uterine Artery Pulsatility Indices in Preterm Labor
1 other identifier
observational
200
0 countries
N/A
Brief Summary
Study included all pregnant women admitted with threatened preterm labor during the study period. All participants underwent estimation of maternal serum homocysteine level and assessment of uterine artery Doppler indices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2015
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 5, 2018
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedFebruary 22, 2018
February 1, 2018
2.3 years
February 5, 2018
February 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The accuracy of serum homocysteine levels and uterine artery pulsatility indices (UtA-PI ) for prediction of preterm labor
Sensitivity (%), specificity (%), positive predictive value (%), negative predictive value (%), positive likelihood ratio (number), negative likelihood ratio (number), accuracy (%) of serum homocysteine and UtA-PI for prediction of preterm labor
Single measurement at the end of the study ( around 37 gestational weeks)
Secondary Outcomes (2)
Gestational age at delivery
Single measurement at the end of the study ( around 37 gestational weeks)
Demographic and clinical characteristics of the study groups
Single measurement on the day one of hospital admission between 28-35 gestational weeks
Study Arms (2)
Preterm group
included pregnant females delivered prior to completed 37 weeks of gestation. All participants underwent assessment of uterine artery Doppler indices and maternal serum homocysteine estimation
Term group
Included pregnant females delivered after completed 37 weeks of gestation. All participants underwent assessment of uterine artery Doppler indices and maternal serum homocysteine estimation
Interventions
Uterine artery Doppler pulsatility indices
Eligibility Criteria
Pregnant with singleton pregnancy, more than 28 and less than 35 gestational weeks.
You may qualify if:
- Singleton pregnancy
- More than 28 and less than 35 gestational weeks.
- Threatened preterm labor
You may not qualify if:
- Medical disorders complicating pregnancy
- Obstetric conditions complicating pregnancy (e.g., placenta previa, multiple gestation,PPROM, ....etc)
- Fetal anomalies or distress
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant proffessor of Obestetrics &Gynecology
Study Record Dates
First Submitted
February 5, 2018
First Posted
February 22, 2018
Study Start
August 1, 2015
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
February 22, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share