Clinical trial NCT04104984: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Preterm Labour
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 966
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: preterm birth, defined as delivery before 37 weeks 0 days of gestation
timeFrame: baseline
Secondary outcomes:
measure: Mean GA at delivery
timeFrame: baseline
measure: Birth Wight less than 2500 grams.
timeFrame: baseline
measure: Birth Wight ( mean +SD) in grams
timeFrame: baseline
measure: compliance to medication.
timeFrame: baseline
measure: side effect related to intervention either progesterone or cercalage
timeFrame: baseline
measure: Mode of delivery
timeFrame: baseline
measure: perinatal mortality.
timeFrame: baseline
measure: Neonatal morbidity
timeFrame: baseline
measure: admission to Neonatal intensive care unit
timeFrame: baseline
measure: Maternal morbidity
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Asssiut University
name: Alaa Eldeen M Ismail, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Ahmed M Alaa eldeen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asssiut University
name: Hany A Ali, MD
role: PRINCIPAL_INVESTIGATOR
References: