Detection of Preterm Labour by Cervical Length
Primary Purpose
Preterm Labour
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
transvaginal ultrasound
Progesterone Vaginal Suppository
cervical cercalage
digital vaginal exam
abdominal ultrasound
Tocolytic Agents
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Labour
Eligibility Criteria
Inclusion Criteria:
- pregnant women with gestational age between 14-24 weeks and having singletone or multiple viable fetus
Exclusion Criteria:
.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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
control group not follow NICE guide lines
study group follow NICE guide lines
Arm Description
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.
- 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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Mean GA at delivery
detection of Mean gastational age at delivery
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.
Birth Wight ( mean +SD) in grams
detection of Birth Wight ( mean +SD) in grams
compliance to medication.
determine if the 466 of study group patient taking the medication regularly as progesterone vaginal suppository by questioning the patient.
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
Mode of delivery
recording which patients deliver normal vaginal delivery or by cesarean section
perinatal mortality.
record the numbers of perinatal death who's mothers undergo treatment during pregnancy of overall 922 patients
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 .
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 .
Maternal morbidity
record Maternal morbidity like maternal haemorrhage , maternal infection ,maternal medication from 922 patients with short cervix.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04104984
Brief Title
Detection of Preterm Labour by Cervical Length
Official Title
Antenatal Management Based on Transvaginal Ultrasound Cervical Length Screening for Preventing Preterm Birth
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2020 (Anticipated)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
November 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labour
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
966 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group not follow NICE guide lines
Arm Type
Experimental
Arm Description
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.
Arm Title
study group follow NICE guide lines
Arm Type
Experimental
Arm 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 . and will be managed according NICE guide lines
Intervention Type
Device
Intervention Name(s)
transvaginal ultrasound
Intervention Description
a transvaginal ultrasound is done to patient to determine cervical length
Intervention Type
Drug
Intervention Name(s)
Progesterone Vaginal Suppository
Intervention Description
a progesterone vaginal suppository to prevent preterm labour
Intervention Type
Procedure
Intervention Name(s)
cervical cercalage
Intervention Description
Mcdonald's cervical cercalage . a stitch taken around the cervix to prevent preterm labour
Intervention Type
Other
Intervention Name(s)
digital vaginal exam
Intervention Description
vaginal examination to detect short cervix
Intervention Type
Device
Intervention Name(s)
abdominal ultrasound
Intervention Description
use abdominal ultrasound to measure cervical length
Intervention Type
Drug
Intervention Name(s)
Tocolytic Agents
Intervention Description
a medication is given to prevent uterine contraction
Primary Outcome Measure Information:
Title
preterm birth, defined as delivery before 37 weeks 0 days of gestation
Description
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
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Mean GA at delivery
Description
detection of Mean gastational age at delivery
Time Frame
baseline
Title
Birth Wight less than 2500 grams.
Description
determine number of infants born from patients with short cervix and undergo management and record Birth Wight less than 2500 grams.
Time Frame
baseline
Title
Birth Wight ( mean +SD) in grams
Description
detection of Birth Wight ( mean +SD) in grams
Time Frame
baseline
Title
compliance to medication.
Description
determine if the 466 of study group patient taking the medication regularly as progesterone vaginal suppository by questioning the patient.
Time Frame
baseline
Title
side effect related to intervention either progesterone or cercalage
Description
detection and record the side effect related to intervention either progesterone or cercalage by questioning the patient
Time Frame
baseline
Title
Mode of delivery
Description
recording which patients deliver normal vaginal delivery or by cesarean section
Time Frame
baseline
Title
perinatal mortality.
Description
record the numbers of perinatal death who's mothers undergo treatment during pregnancy of overall 922 patients
Time Frame
baseline
Title
Neonatal morbidity
Description
record infants born to mother of study group and study group after birth with any morbidity like respiratory distress syndrome,necrotizing enterocolities,jaundice .
Time Frame
baseline
Title
admission to Neonatal intensive care unit
Description
determine which infant born will be admitted to the intensive care unit after delivery and record numbers of infants .
Time Frame
baseline
Title
Maternal morbidity
Description
record Maternal morbidity like maternal haemorrhage , maternal infection ,maternal medication from 922 patients with short cervix.
Time Frame
baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pregnant women with gestational age between 14-24 weeks and having singletone or multiple viable fetus
Exclusion Criteria:
.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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shehab A Millad, MD
Phone
+201206507003
Email
shehab_yanni@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa Eldeen M Ismail, MD
Organizational Affiliation
Asssiut University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed M Alaa eldeen, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hany A Ali, MD
Organizational Affiliation
Asssiut University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Detection of Preterm Labour by Cervical Length
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