Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
EARLY_PHASE1
966 participants
INTERVENTIONAL
2020-02-15
2021-11-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prediction of Preterm Delivery with Serial Cervical Length Measurements After Threatened Preterm Labor
NCT05044143
Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth
NCT03591042
Cervical Volume and Prediction of Preterm Labor
NCT06190496
Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth
NCT02928302
Prevention and Treatment of Premature Labour for Asymptomatic Pregnant Women
NCT02598323
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* History taking .Obstetric history will be obtained from the patient includes gravidity and parity , last menstrual period , duration of gestation at birth time , mode of delivery , gender, birth Wight, any complication in each pregnancy, miscarriage and causes of miscarriage . Past history will be obtained from the patient for any medical disease like ( severe anaemia, hypertensive disease, heart disease, antiretroviral therapy in pregnancy and genitourinary infection) and History of cervical cercalage . Family history will be obtained to determine any history of family preterm birth. Socioeconomic status will be obtained include occupation and financial status. Special Habits for both couples.
* Gynaecological history will be taken from the patient include any vaginal bleeding, history of vaginal infection, operations like D and C with cervical dilatation.
* Examination Examination of the patient include vital signs, general examination ( head, neck ,chest ,heart ) obstetric examination include inspection, palpation, auscultation and speculum vaginal examination.
* -Investigation Investigation includes antenatal care laboratory tests like urine analysis ,CBC, RH factor and random blood sugar .
* Transvaginal ultrasound:
Study group : Cervical length will be measured using transvaginal ultrasonography with the standard longitudinal view of cervix while patient's bladder is empty. TVS probe will be used to measure cervical length. It will be measured by keeping the probe 3cm away from the posterior fornix. The cervical length is defined as the length between the internal OS and external OS
Those with short cervix less than 25 mm will be managed According to NICE guide lines :
Offer a choice of either prophylactic vaginal progesterone or prophylactic cervical cerclage to women: with a history of spontaneous preterm birth or mid-trimester loss between 16+0 and 34+0 weeks of pregnancy and in whom a transvaginal ultrasound scan has been carried out between 16+0 and 24+0 weeks of pregnancy that reveals a cervical length of less than 25 mm.
Discuss the benefits and risks of prophylactic progesterone and cervical cerclage with the woman and take her preferences into account.
Offer prophylactic vaginal progesterone to women with no history of spontaneous preterm birth or mid-trimester loss in whom a transvaginal ultrasound scan has been carried out between 16+0 and 24+0 weeks of pregnancy that reveals a cervical length of less than 25 mm.
Consider prophylactic cervical cerclage for women in whom a transvaginal ultrasound scan has been carried out between 16+0 and 24+0 weeks of pregnancy that reveals a cervical length of less than 25 mm and who have either: had preterm prelabour rupture of membranes (P-PROM) in a previous pregnancy or a history of cervical trauma (17) .
progesterone will be given in form of vaginal suppository 200 mg once daily . Start receiving it once diagnoses is established till 34 week gestation.
A McDonald cerclage will be be preformed for women once diagnoses is established and removed at 36 week gestational or when labour pain start.
Control group : All pregnant women who fulfil the same inclusion criteria, exclusion criteria, diagnoses established as short cervix by digital vaginal exam or trans abdominal ultrasound or not specified and do not undergo transvaginal ultrasound assessment , and do not managed according to NICE guide lines will be treated and managed according to their units as a control group.
• Then all patients will be followed up every 4 weeks by taking history , any complaint of new symptoms , compliance to treatment, obstetric exam and investigation if indicated till delivery and record the time of delivery or termination of pregnancy. After delivery, record maternal and fetal outcome.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
control group not follow NICE guide lines
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.
digital vaginal exam
vaginal examination to detect short cervix
abdominal ultrasound
use abdominal ultrasound to measure cervical length
Tocolytic Agents
a medication is given to prevent uterine contraction
study group follow NICE guide lines
\- 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
transvaginal ultrasound
a transvaginal ultrasound is done to patient to determine cervical length
Progesterone Vaginal Suppository
a progesterone vaginal suppository to prevent preterm labour
cervical cercalage
Mcdonald's cervical cercalage . a stitch taken around the cervix to prevent preterm labour
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
transvaginal ultrasound
a transvaginal ultrasound is done to patient to determine cervical length
Progesterone Vaginal Suppository
a progesterone vaginal suppository to prevent preterm labour
cervical cercalage
Mcdonald's cervical cercalage . a stitch taken around the cervix to prevent preterm labour
digital vaginal exam
vaginal examination to detect short cervix
abdominal ultrasound
use abdominal ultrasound to measure cervical length
Tocolytic Agents
a medication is given to prevent uterine contraction
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
16 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shehab Alam Millad
principle investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alaa Eldeen M Ismail, MD
Role: PRINCIPAL_INVESTIGATOR
Asssiut University
Ahmed M Alaa eldeen, MD
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Hany A Ali, MD
Role: PRINCIPAL_INVESTIGATOR
Asssiut University
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VUS cervical Length
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.