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

Preterm Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03440281
• Other study ID #: 1182015
• Status: Completed
• Phase: N/A
• First received: February 5, 2018
• Last updated: February 14, 2018
• Start date: August 1, 2015
• Est. completion date: November 1, 2017

Study information

• Verified date: February 2018
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Diagnostic Test:
• Uterine artery doppler
Uterine artery Doppler pulsatility indices
• Maternal serum homocysteine estimation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gestational age at delivery	Gestational age at delivery (Weeks),	Single measurement at the end of the study ( around 37 gestational weeks)
Secondary	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