NCT07336173

Brief 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 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 .

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

January 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 2, 2026

Last Update Submit

January 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    From 24 to 34 weeks gestation

Interventions

Trans abdominal ultrasound will be used to measure uterine artery doppler indices Trans vaginal ultrasound will be used to measure anterior uterocervical angle

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly pregnant females
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Eligible participants will be recruited among those attending the antenatal clinic or Obstetrics Emergency Unite at Kafrelsheikh University Hospital.

You may qualify if:

  • 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%.

You may not qualify if:

  • Obstetric:
  • Ruptured membranes
  • Clinical evidence of Chorioamnionitis.
  • Fetal compromise on evaluation.
  • Severe obstetric complications (e.g., severe Preeclampsia, Eclampsia).
  • Diagnosed intrauterine growth restriction (IUGR).
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafr elsheikh university hospital

Kafr ash Shaykh, Egypt

RECRUITING

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Nourhan M Shalaby, Master

CONTACT

Ahmed M Fathy, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician doctor

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 13, 2026

Study Start

January 15, 2026

Primary Completion

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations