Preterm LaborNCT03440281
Maternal Serum Homocysteine Levels and Uterine Artery Pulsatility Indices in Preterm Labor
An observational study of Preterm Labor, run by Benha University.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- Uterine artery doppler and Maternal serum homocysteine estimation
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 1 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Adult
Study population: Pregnant with singleton pregnancy, more than 28 and less than 35 gestational weeks.
Who may be able to join
- Singleton pregnancy
- More than 28 and less than 35 gestational weeks.
- Threatened preterm labor
Who cannot join
- Medical disorders complicating pregnancy
- Obstetric conditions complicating pregnancy (e.g., placenta previa, multiple gestation,PPROM, ....etc)
- Fetal anomalies or distress
About this study
Official title: Maternal Serum Homocysteine Levels and Uterine Artery Pulsatility Index as Predictors of Spontaneous 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.
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.
- Conditions
- Preterm Labor
- Being tested
- Uterine artery doppler, Maternal serum homocysteine estimation
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine artery dopplerDiagnostic test
Uterine artery Doppler pulsatility indices
Maternal serum homocysteine estimationDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Uterine artery doppler; Diagnostic Test: Maternal serum homocysteine estimation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Single measurement at the end of the study ( around 37 gestational weeks)
Secondary outcomes (2)
Gestational age at delivery
Gestational age at delivery (Weeks),
Measured: 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)
Measured: Single measurement on the day one of hospital admission between 28-35 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Aug 2015
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Walid Anwar Murad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440281
- Sponsor's protocol ID
- 1182015
- Status last verified
- Feb 2018
- First submitted
- 5 Feb 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Serum Homocysteine Levels and Uterine Artery Pulsatility Index as Predictors of Spontaneous Preterm Labor
- ClinicalTrials.gov ID
- NCT03440281
- Acronym / sponsor ID
- 1182015
- Conditions
- Preterm Labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm group | – | Diagnostic Test: Uterine artery doppler, Diagnostic Test: Maternal serum homocysteine estimationincluded 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 | – | Diagnostic Test: Uterine artery doppler, Diagnostic Test: Maternal serum homocysteine estimationIncluded pregnant females delivered after completed 37 weeks of gestation. All participants underwent assessment of uterine artery Doppler indices and maternal serum homocysteine estimation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant with singleton pregnancy, more than 28 and less than 35 gestational weeks.
Key inclusion criteria (3 listed)
- Singleton pregnancy
- More than 28 and less than 35 gestational weeks.
- Threatened preterm labor
Key exclusion criteria (3 listed)
- Medical disorders complicating pregnancy
- Obstetric conditions complicating pregnancy (e.g., placenta previa, multiple gestation,PPROM, ....etc)
- Fetal anomalies or distress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine artery dopplerUterine artery Doppler pulsatility indices | Diagnostic test | Preterm group, Term group |
| Maternal serum homocysteine estimation | Diagnostic test | Preterm group, Term group |
Primary outcome
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
2 secondary outcomes
Gestational age at delivery
Time frame: Single measurement at the end of the study ( around 37 gestational weeks)
Demographic and clinical characteristics of the study groups
Time frame: Single measurement on the day one of hospital admission between 28-35 gestational weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor, run by Benha University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.