Detection of Preterm Labour by Cervical Length

Preterm Labour Clinical Trial

Official title:

Antenatal Management Based on Transvaginal Ultrasound Cervical Length Screening for Preventing Preterm Birth

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04104984
• Other study ID #: VUS cervical Length
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: February 15, 2020
• Est. completion date: November 15, 2021

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: Shehab A Millad, MD
• Phone: +201206507003
• Email: shehab_yanni[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 966
• Est. completion date: November 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labour

Intervention

Device:
• transvaginal ultrasound
a transvaginal ultrasound is done to patient to determine cervical length

Drug:
• Progesterone Vaginal Suppository
a progesterone vaginal suppository to prevent preterm labour

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

Other:
• digital vaginal exam
vaginal examination to detect short cervix

Device:
• abdominal ultrasound
use abdominal ultrasound to measure cervical length

Drug:
• Tocolytic Agents
a medication is given to prevent uterine contraction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean GA at delivery	detection of Mean gastational age at delivery	baseline
Secondary	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.	baseline
Secondary	Birth Wight ( mean +SD) in grams	detection of Birth Wight ( mean +SD) in grams	baseline
Secondary	compliance to medication.	determine if the 466 of study group patient taking the medication regularly as progesterone vaginal suppository by questioning the patient.	baseline
Secondary	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	baseline
Secondary	Mode of delivery	recording which patients deliver normal vaginal delivery or by cesarean section	baseline
Secondary	perinatal mortality.	record the numbers of perinatal death who's mothers undergo treatment during pregnancy of overall 922 patients	baseline
Secondary	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 .	baseline
Secondary	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 .	baseline
Secondary	Maternal morbidity	record Maternal morbidity like maternal haemorrhage , maternal infection ,maternal medication from 922 patients with short cervix.	baseline