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

Completed

• Conditions: Preterm Labor
• Interventions: Diagnostic Test: Uterine artery doppler; Diagnostic Test: Maternal serum homocysteine estimation

• Registration Number: NCT03440281
• Lead Sponsor: Benha University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-08-01
• Primary Completion: 2017-11-01
• Study Completion: 2017-11-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-14
• Last Update Submitted: 2018-02-14
• Study First Posted: 2018-02-22
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preterm group	Maternal serum homocysteine estimation	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
Preterm group	Uterine artery doppler	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	Maternal serum homocysteine estimation	Included pregnant females delivered after completed 37 weeks of gestation. All participants underwent assessment of uterine artery Doppler indices and maternal serum homocysteine estimation
Term group	Uterine artery doppler	Included pregnant females delivered after completed 37 weeks of gestation. All participants underwent assessment of uterine artery Doppler indices and maternal serum homocysteine estimation

Primary Outcome Measures

Name	Time	Method
The accuracy of serum homocysteine levels and uterine artery pulsatility indices (UtA-PI ) for prediction of preterm labor	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 Outcome Measures

Name	Time	Method
Gestational age at delivery	Single measurement at the end of the study ( around 37 gestational weeks)	Gestational age at delivery (Weeks),
Demographic and clinical characteristics of the study groups	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)