Preterm LabourEarly Phase 1NCT04104984
Detection of Preterm Labour by Cervical Length
A Early Phase 1 study testing transvaginal ultrasound, Progesterone Vaginal Suppository and cervical cercalage in people with Preterm Labour, run by Assiut University.
Trial summary
Detection of short cervix by transvaginal ultrasound and its evidence based management to prevent preterm birth . Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labour
- What is being tested?
- transvaginal ultrasound, Progesterone Vaginal Suppository and cervical cercalage
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 966 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2020to 15 Nov 2021
- Phase
- Early Phase 1
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- pregnant women with gestational age between 14-24 weeks and having singletone or multiple viable fetus
Who cannot join
- .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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Antenatal Management Based on Transvaginal Ultrasound Cervical Length Screening for Preventing Preterm Birth
Detection of short cervix by transvaginal ultrasound and its evidence based management to prevent preterm birth .
Read the detailed description
- 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 .
- 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
- Preterm Labour
- Being tested
- transvaginal ultrasound, Progesterone Vaginal Suppository, cervical cercalage, digital vaginal exam, abdominal 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.
transvaginal ultrasoundDevice
a transvaginal ultrasound is done to patient to determine cervical length
Progesterone Vaginal SuppositoryDrug
a progesterone vaginal suppository to prevent preterm labour
cervical cercalageProcedure or surgery
Mcdonald's cervical cercalage . a stitch taken around the cervix to prevent preterm labour
digital vaginal examOther
vaginal examination to detect short cervix
abdominal ultrasoundDevice
use abdominal ultrasound to measure cervical length
Tocolytic AgentsDrug
a medication is given to prevent uterine contraction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: digital vaginal exam; Device: abdominal ultrasound; Drug: 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 Receives: Device: transvaginal ultrasound; Drug: Progesterone Vaginal Suppository; Procedure: cervical cercalage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (10)
Mean GA at delivery
detection of Mean gastational age at delivery
Measured: baseline
Birth Wight less than 2500 grams.
determine number of infants born from patients with short cervix and undergo management and record Birth Wight less than 2500 grams.
Measured: baseline
Birth Wight ( mean +SD) in grams
detection of Birth Wight ( mean +SD) in grams
Measured: baseline
compliance to medication.
determine if the 466 of study group patient taking the medication regularly as progesterone vaginal suppository by questioning the patient.
Measured: baseline
side effect related to intervention either progesterone or cercalage
detection and record the side effect related to intervention either progesterone or cercalage by questioning the patient
Measured: baseline
Mode of delivery
recording which patients deliver normal vaginal delivery or by cesarean section
Measured: baseline
perinatal mortality.
record the numbers of perinatal death who's mothers undergo treatment during pregnancy of overall 922 patients
Measured: baseline
Neonatal morbidity
record infants born to mother of study group and study group after birth with any morbidity like respiratory distress syndrome,necrotizing enterocolities,jaundice .
Measured: baseline
admission to Neonatal intensive care unit
determine which infant born will be admitted to the intensive care unit after delivery and record numbers of infants .
Measured: baseline
Maternal morbidity
record Maternal morbidity like maternal haemorrhage , maternal infection ,maternal medication from 922 patients with short cervix.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start15 Feb 2020 (estimated)
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LabourStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 966 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shehab Alam Millad, Assiut University
- Investigators
- Alaa Eldeen M Ismail, MD, Principal investigator, Asssiut UniversityAhmed M Alaa eldeen, MD, Principal investigator, Assiut UniversityHany A Ali, MD, Principal investigator, Asssiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104984
- Sponsor's protocol ID
- VUS cervical Length
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Management Based on Transvaginal Ultrasound Cervical Length Screening for Preventing Preterm Birth
- ClinicalTrials.gov ID
- NCT04104984
- Acronym / sponsor ID
- VUS cervical Length
- Conditions
- Preterm Labour
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 966 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Feb 2020 (estimated)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Nov 2021 (estimated)
- First posted
- 26 Sep 2019 (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.
Detection of short cervix by transvaginal ultrasound and its evidence based management to prevent preterm birth .
Detailed description
- 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 .
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group not follow NICE guide lines | Experimental | Other: digital vaginal exam, Device: abdominal ultrasound, Drug: Tocolytic AgentsAll 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. |
| study group follow NICE guide lines | Experimental | Device: transvaginal ultrasound, Drug: Progesterone Vaginal Suppository, Procedure: cervical cercalage- 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 |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- pregnant women with gestational age between 14-24 weeks and having singletone or multiple viable fetus
Key exclusion criteria (3 listed)
- .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.
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 |
|---|---|---|
| transvaginal ultrasounda transvaginal ultrasound is done to patient to determine cervical length | Device | study group follow NICE guide lines |
| Progesterone Vaginal Suppositorya progesterone vaginal suppository to prevent preterm labour | Drug | study group follow NICE guide lines |
| cervical cercalageMcdonald's cervical cercalage . a stitch taken around the cervix to prevent preterm labour | Procedure or surgery | study group follow NICE guide lines |
| digital vaginal examvaginal examination to detect short cervix | Other | control group not follow NICE guide lines |
| abdominal ultrasounduse abdominal ultrasound to measure cervical length | Device | control group not follow NICE guide lines |
| Tocolytic Agentsa medication is given to prevent uterine contraction | Drug | control group not follow NICE guide lines |
Primary outcome
preterm birth, defined as delivery before 37 weeks 0 days of gestation
Time frame: baseline
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
10 secondary outcomes
Mean GA at delivery
Time frame: baseline
Birth Wight less than 2500 grams.
Time frame: baseline
Birth Wight ( mean +SD) in grams
Time frame: baseline
compliance to medication.
Time frame: baseline
side effect related to intervention either progesterone or cercalage
Time frame: baseline
Mode of delivery
Time frame: baseline
perinatal mortality.
Time frame: baseline
Neonatal morbidity
Time frame: baseline
admission to Neonatal intensive care unit
Time frame: baseline
Maternal morbidity
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
Related trials for Preterm Labour
RecruitingObservational study
Cervical Stiffness in Women With Threatened Preterm Labor
Preterm Labor, Preterm Birth
Recruiting
Intravenous Papaverine for Term Prelabor Rupture of Membranes
Premature Rupture of Fetal Membranes
Recruiting
Maternal Stress on Human Milk and Infant Outcomes
Postpartum Depression, Preterm Labor
Active, not recruitingObservational study
Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?
Preterm Birth, Preterm Labor
Active, not recruitingObservational study
IL-6 and Lactates in Cord Blood and Neonatal Outcomes
Fetal Infection, Fetal Inflammatory Response Syndrome
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.
Alaa Eldeen M Ismail, MD principal investigator
Asssiut University
Ahmed M Alaa eldeen, MD principal investigator
Assiut University
Hany A Ali, MD principal investigator
Asssiut University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing transvaginal ultrasound, Progesterone Vaginal Suppository and cervical cercalage in people with Preterm Labour, run by Assiut University.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shehab A Millad, MD (+201206507003, shehab_yanni@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preterm birth, defined as delivery before 37 weeks 0 days of gestation (time frame: baseline). 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 14 Jan 2020.