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CompletedNCT03440281Updated Feb 22, 2018

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

An observational study in Preterm Labor, sponsored by Benha University. Completed. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-02-22.

Sponsored by Benha University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 35 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

Pregnant with singleton pregnancy, more than 28 and less than 35 gestational weeks.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Diagnostic Test: Uterine artery doppler · Diagnostic Test: 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

    Diagnostic Test: Uterine artery doppler · Diagnostic Test: Maternal serum homocysteine estimation

Interventions

  • Diagnostic testUterine artery doppler

    Uterine artery Doppler pulsatility indices

  • Diagnostic testMaternal serum homocysteine estimation
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What researchers measure

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

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

Secondary outcomes

  1. Gestational age at delivery

    Gestational age at delivery (Weeks),

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

  2. 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)

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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03440281
Lead sponsor
Benha University
Responsible party
Ahmed Walid Anwar Murad (Assisstant proffessor of Obestetrics &Gynecology, Benha University) — Principal investigator
First posted
Feb 22, 2018
Start date
Aug 1, 2015
Primary completion
Nov 1, 2017
Completion
Nov 1, 2017
Last update
Feb 22, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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