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NCT Number: NCT03440281

Maternal Serum Homocysteine Levels and Uterine Artery Pulsatility Indices in Preterm Labor

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.

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Key information

Conditions

Preterm Labor Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

About this study

Prospective cohort study. Study approval by local ethics committee. Informed written consent. 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton pregnancy
  • More than 28 and less than 35 gestational weeks.
  • Threatened preterm labor

Exclusion criteria

  • Medical disorders complicating pregnancy
  • Obstetric conditions complicating pregnancy (e.g., placenta previa, multiple gestation,PPROM, ....etc)
  • Fetal anomalies or distress

Treatment and study plan

Uterine artery doppler

Diagnostic Test

Uterine artery Doppler pulsatility indices

Maternal serum homocysteine estimation

Diagnostic Test

Primary outcomes

  1. The accuracy of serum homocysteine levels and uterine artery pulsatility indices (UtA-PI ) for prediction of preterm labor

    Time frame: Single measurement at the end of the study ( around 37 gestational weeks)

    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

Secondary outcomes

  1. Gestational age at delivery

    Time frame: Single measurement at the end of the study ( around 37 gestational weeks)

    Gestational age at delivery (Weeks),

  2. Demographic and clinical characteristics of the study groups

    Time frame: Single measurement on the day one of hospital admission between 28-35 gestational weeks

    Maternal age (year), Body mass index (kilogram per squared meter), Gestational age at admission (Weeks), Maternal serum Homocysteine level ( micromoles/liter), uterine artery pulsatility index ( number)

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Maternal Serum Homocysteine Levels and Uterine Artery Pulsatility Index as Predictors of Spontaneous Preterm Labor

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 22, 2018
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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