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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Preterm Labor

Intervention / Treatment
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* Diagnostic Test: Uterine artery doppler
* Diagnostic Test: Maternal serum homocysteine estimation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm group<br>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 | Diagnostic Test: Uterine artery doppler<br>* Uterine artery Doppler pulsatility indices<br>Diagnostic Test: Maternal serum homocysteine estimation<br> <br> |
| Term group<br>Included pregnant females delivered after completed 37 weeks of gestation. All participants underwent assessment of uterine artery Doppler indices and maternal serum homocysteine estimation | Diagnostic Test: Uterine artery doppler<br>* Uterine artery Doppler pulsatility indices<br>Diagnostic Test: Maternal serum homocysteine estimation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at delivery | Gestational age at delivery (Weeks), | Single measurement at the end of the study ( around 37 gestational weeks) | 
| Demographic and clinical characteristics of the study groups | 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) | Single measurement on the day one of hospital admission between 28-35 gestational weeks |