Antenatal Management Based on Transvaginal Ultrasound Cervical Length Screening for Preventing Preterm Birth
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 966
- 主要终点
- preterm birth, defined as delivery before 37 weeks 0 days of gestation
研究概览
简要总结
Detection of short cervix by transvaginal ultrasound and its evidence based management to prevent preterm birth .
详细描述
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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 .
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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.
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Gynaecological history will be taken from the patient include any vaginal bleeding, history of vaginal infection, operations like D and C with cervical dilatation.
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Examination Examination of the patient include vital signs, general examination ( head, neck ,chest ,heart ) obstetric examination include inspection, palpation, auscultation and speculum vaginal examination.
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-Investigation Investigation includes antenatal care laboratory tests like urine analysis ,CBC, RH factor and random blood sugar .
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women with gestational age between 14-24 weeks and having singletone or multiple viable fetus
排除标准
- •.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.
研究组 & 干预措施
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.
干预措施: digital vaginal exam (Other)
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.
干预措施: abdominal ultrasound (Device)
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.
干预措施: Tocolytic Agents (Drug)
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
干预措施: transvaginal ultrasound (Device)
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
干预措施: Progesterone Vaginal Suppository (Drug)
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
干预措施: cervical cercalage (Procedure)
结局指标
主要结局
preterm birth, defined as delivery before 37 weeks 0 days of gestation
时间窗: 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
次要结局
- Birth Wight ( mean +SD) in grams(baseline)
- perinatal mortality.(baseline)
- Neonatal morbidity(baseline)
- admission to Neonatal intensive care unit(baseline)
- Mean GA at delivery(baseline)
- Birth Wight less than 2500 grams.(baseline)
- compliance to medication.(baseline)
- side effect related to intervention either progesterone or cercalage(baseline)
- Mode of delivery(baseline)
- Maternal morbidity(baseline)
研究者
Shehab Alam Millad
principle investigator
Assiut University