Preterm LaborNCT07336173
Uterine Artery Doppler Indices and Uterocervical Angle Measurment in Prediction of Preterm Labor
An observational study of Preterm Labor, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The goal of this observational study is to evaluate the role of uterine artery doppler indices and uterocervical angle measurement in prediction of preterm labor .The main question it aims to answer is: Does combination of both uterine artery doppler indices and uterocervical angle measurement increase sensitivity and… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2026to 8 Jul 2026
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Eligible participants will be recruited among those attending the antenatal clinic or Obstetrics Emergency Unite at Kafrelsheikh University Hospital.
Who may be able to join
- Patient who will give verbal \& written will informed consent.
- Pregnant women between 18 and 40 years old of age
- Singleton pregnancy
- Gestational age will be confirmed by first trimester ultrasound scan (<14 weeks).
- Gestational age between 24 and 34 weeks .
- Threatened preterm labor which is defined as:
- Presence of at least one uterine contraction every 10 minutes lasting ≥30 seconds . Cervical dilatation ≤3 cm . Cervical effacement <80%.
Who cannot join
- Obstetric:
- Ruptured membranes
- Clinical evidence of Chorioamnionitis.
- Fetal compromise on evaluation.
- Severe obstetric complications (e.g., severe Preeclampsia, Eclampsia).
- Diagnosed intrauterine growth restriction (IUGR).
Show all 12Show fewer
- Congenital fetal anomalies.
- Multiple pregnancies.
- Prior cervical surgery (e.g., cone biopsy, cerclage).
- Non-Obstetric:
- Significant maternal medical disorders (e.g., chronic hypertension, diabetes mellitus, liver dysfunction).
- Severe non-obstetric complications (e.g., acute abdomen).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Uterine Artery Doppler Indices and Sonographic Measurement of Uterocervical Angle in Predicting Preterm Labor
The goal of this observational study is to evaluate the role of uterine artery doppler indices and uterocervical angle measurement in prediction of preterm labor .The main question it aims to answer is:
Does combination of both uterine artery doppler indices and uterocervical angle measurement increase sensitivity and specificity for prediction of established preterm labor ? Participants already performing uterine artery doppler as part of their regular antenatal care .measurement of anterior uterocervical angle will be added between 24 to 34 weeks gestation to predict preterm labor in candidates .
Read the detailed description
In this study the aim is to evaluate the combined predictive value of both uterine artery doppler and uterocervical angle measurement in a prospective cohort study design to predict preterm labor . The abnormal mid-trimester uterine artery resistance, pulsatility index and diastolic notching measured with Doppler sonography is known to be predictive for preeclampsia and, hence, for iatrogenic Preterm labor. It will be measured via trans abdominal approach.
The measurement of UCA in the second trimester of pregnancy is strongly associated with the occurrence of spontaneous Preterm labor and will be measured via transvaginal approach .
Both measurement will be conducted between 24 to 34 weeks gestational .
- Conditions
- Preterm Labor
- Being tested
- Ultrasound
- 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.
UltrasoundDevice
Trans abdominal ultrasound will be used to measure uterine artery doppler indices Trans vaginal ultrasound will be used to measure anterior uterocervical angle
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity and accuracy performance of uterine artery Doppler indices and uterocervical angle assed by ultrasound for prediction of preterm labor
Its hypothesized that:
Abnormal uterine artery Doppler indices and an abnormal (acute) uterocervical angle (< 95°) are significant predictors of preterm labor. The combination of these two parameters will enhance the sensitivity and specificity of preterm labor prediction.
Measured: From 24 to 34 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start15 Jan 2026
- Primary completion8 Jul 2026
- Study completion8 Jul 2026
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 Kafrelsheikh 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Moustafa Elsayed Shalaby, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336173
- Sponsor's protocol ID
- KFSIRB200-597
- Status last verified
- Aug 2026
- First submitted
- 2 Jan 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Uterine Artery Doppler Indices and Sonographic Measurement of Uterocervical Angle in Predicting Preterm Labor
- ClinicalTrials.gov ID
- NCT07336173
- Acronym / sponsor ID
- KFSIRB200-597
- Conditions
- Preterm Labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 8 Jul 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 13 Jan 2026 (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.
The goal of this observational study is to evaluate the role of uterine artery doppler indices and uterocervical angle measurement in prediction of preterm labor .The main question it aims to answer is:
Does combination of both uterine artery doppler indices and uterocervical angle measurement increase sensitivity and specificity for prediction of established preterm labor ? Participants already performing uterine artery doppler as part of their regular antenatal care .measurement of anterior uterocervical angle will be added between 24 to 34 weeks gestation to predict preterm labor in candidates .
Detailed description
In this study the aim is to evaluate the combined predictive value of both uterine artery doppler and uterocervical angle measurement in a prospective cohort study design to predict preterm labor . The abnormal mid-trimester uterine artery resistance, pulsatility index and diastolic notching measured with Doppler sonography is known to be predictive for preeclampsia and, hence, for iatrogenic Preterm labor. It will be measured via trans abdominal approach.
The measurement of UCA in the second trimester of pregnancy is strongly associated with the occurrence of spontaneous Preterm labor and will be measured via transvaginal approach .
Both measurement will be conducted between 24 to 34 weeks gestational .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Eligible participants will be recruited among those attending the antenatal clinic or Obstetrics Emergency Unite at Kafrelsheikh University Hospital.
Key inclusion criteria (7 listed)
- Patient who will give verbal \& written will informed consent.
- Pregnant women between 18 and 40 years old of age
- Singleton pregnancy
- Gestational age will be confirmed by first trimester ultrasound scan (<14 weeks).
- Gestational age between 24 and 34 weeks .
Key exclusion criteria (12 listed)
- Ruptured membranes
- Clinical evidence of Chorioamnionitis.
- Fetal compromise on evaluation.
- Severe obstetric complications (e.g., severe Preeclampsia, Eclampsia).
- Diagnosed intrauterine growth restriction (IUGR).
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 |
|---|---|---|
| UltrasoundTrans abdominal ultrasound will be used to measure uterine artery doppler indices Trans vaginal ultrasound will be used to measure anterior uterocervical angle | Device | – |
Primary outcome
Sensitivity, specificity and accuracy performance of uterine artery Doppler indices and uterocervical angle assed by ultrasound for prediction of preterm labor
Time frame: From 24 to 34 weeks gestation
Its hypothesized that: Abnormal uterine artery Doppler indices and an abnormal (acute) uterocervical angle (< 95°) are significant predictors of preterm labor. The combination of these two parameters will enhance the sensitivity and specificity of preterm labor prediction.
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 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Preterm Labor
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor, run by Kafrelsheikh University at 1 site in Egypt.
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 7 inclusion and 12 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Sensitivity, specificity and accuracy performance of uterine artery Doppler indices and uterocervical angle assed by ultrasound for prediction of preterm labor (time frame: From 24 to 34 weeks gestation). 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 10 Aug 2026.