NCT04104984

Brief Summary

Detection of short cervix by transvaginal ultrasound and its evidence based management to prevent preterm birth .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
966

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2020

Status
unknown

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

First Submitted

Initial submission to the registry

September 17, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

February 15, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

January 14, 2020

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

September 17, 2019

Last Update Submit

January 10, 2020

Conditions

Preterm Labour

Outcome Measures

Primary Outcomes (1)

  • preterm birth, defined as delivery before 37 weeks 0 days of gestation

    determine number of patients with preterm birth under 37 week gastational age and trying to prevent early diagnosed conditions from 922 patient diagnosed with short cervix

    baseline

Secondary Outcomes (10)

  • Mean GA at delivery

    baseline

  • Birth Wight less than 2500 grams.

    baseline

  • Birth Wight ( mean +SD) in grams

    baseline

  • compliance to medication.

    baseline

  • side effect related to intervention either progesterone or cercalage

    baseline

  • +5 more secondary outcomes

Study Arms (2)

control group not follow NICE guide lines

EXPERIMENTAL

All pregnant women who fulfil the same inclusion criteria, exclusion criteria, diagnoses established as short cervix , and do not managed according to NICE guide lines will be treated and managed according to their units as a control group.

Other: digital vaginal examDevice: abdominal ultrasoundDrug: Tocolytic Agents

study group follow NICE guide lines

EXPERIMENTAL

\- All pregnant women will attend hospital between 14-24 weeks and fulfil inclusion and exclusion criteria will be approached for possibility to be included in the study . and will be managed according NICE guide lines

Device: transvaginal ultrasoundDrug: Progesterone Vaginal SuppositoryProcedure: cervical cercalage

Interventions

transvaginal ultrasoundDEVICE

a transvaginal ultrasound is done to patient to determine cervical length

study group follow NICE guide lines
Progesterone Vaginal SuppositoryDRUG

a progesterone vaginal suppository to prevent preterm labour

study group follow NICE guide lines
cervical cercalagePROCEDURE

Mcdonald's cervical cercalage . a stitch taken around the cervix to prevent preterm labour

study group follow NICE guide lines
digital vaginal examOTHER

vaginal examination to detect short cervix

control group not follow NICE guide lines
abdominal ultrasoundDEVICE

use abdominal ultrasound to measure cervical length

control group not follow NICE guide lines
Tocolytic AgentsDRUG

a medication is given to prevent uterine contraction

control group not follow NICE guide lines

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • pregnant women with gestational age between 14-24 weeks and having singletone or multiple viable fetus

You may not qualify if:

  • Current Cervical cercalage.
  • Major Fetal malformation .
  • Prenatal infection (bacterial vaginosis ) .Medical comorbidities . .Currently receiving Progesterone treatment. .Pregnancy from assisted reproductive technique . .Threatened miscarriage . .Rupture membrane. .Painful uterine contraction. .Low implanted placenta.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Tocolytic Agents

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Officials

  • Alaa Eldeen M Ismail, MD

    Asssiut University

    PRINCIPAL INVESTIGATOR

  • Ahmed M Alaa eldeen, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Hany A Ali, MD

    Asssiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shehab A Millad, MD

CONTACT

+201206507003shehab_yanni@hotmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 26, 2019

Study Start

February 15, 2020

Primary Completion

September 15, 2021

Study Completion

November 15, 2021

Last Updated

January 14, 2020

Record last verified: 2019-09