NCT06403059

Brief Summary

This prospective study was carried out on 263 pregnant females aged from 19 to 35 years old carrying singleton, and uncomplicated pregnancy. TVS examination was performed in all cases at 28 and 32 weeks of gestation. The pregnant women recruited in the study closely followed up to delivery. Maternal progesterone was given to all women with short CL (\<20mm and more than 10mm) to support pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
263

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 3, 2024

Last Update Submit

May 3, 2024

Conditions

Preterm Pregnancy

Keywords

preterm deliveryCervical LengthUterocervical Angle

Outcome Measures

Primary Outcomes (2)

  • cervical length

    TVS examination

    28 and 32 weeks of gestation

  • uterocervical angle

    TVS examination

    28 and 32 weeks of gestation

Interventions

Cervical LengthDIAGNOSTIC_TEST

trans vaginal ultrasound

Uterocervical AngleDIAGNOSTIC_TEST

by trans vaginal ultrasound

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

28 to 32 weeks

You may qualify if:

  • pregnant 28 to 32 weeks

You may not qualify if:

  • additional signs of preterm labour in the mother
  • foetus, polyhydramnios,
  • multiple pregnancies,
  • a previous cervix operation,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, 62511, Egypt

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Cervical Length Measurement

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography, PrenatalUltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisPrenatal DiagnosisDiagnostic Techniques, Obstetrical and Gynecological

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 7, 2024

Study Start

October 15, 2023

Primary Completion

April 15, 2024

Study Completion

April 30, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Locations

EG(1)