Frequency of Performing Umbilical Artery Doppler in the Third Trimester in High Risk Pregnancy

Not Applicable

Completed

• Conditions: High Risk Pregnancy
• Interventions: Diagnostic Test: Umbilical artery Doppler

• Registration Number: NCT03584763
• Lead Sponsor: Ain Shams University

Brief Summary

The aim of the current study was to produce a high quality evidence on the best frequency of performing umbilical artery Doppler for high risk pregnant women in the third trimester.

Detailed Description

Nowadays, high risk pregnancy forms a significant increasing proportion of any pregnant population, according to some authors up to 50% of all pregnancies would have the label of high risk pregnancies.

At present, it is recommended that high risk pregnancies, thought to be at risk of placental insufficiency should be monitored with Doppler studies of the umbilical artery. Doppler assessment of the placental circulation plays an important role in screening for impaired placentation and its complications of intrauterine growth restriction.

The purpose of umbilical artery Doppler surveillance is to predict fetal academia thereby allowing timely delivery prior to irreversible end-organ damage and intrauterine fetal death.

According to a Cochrane Pregnancy and Childbirth Group's systematic review and meta-analysis, in which Published and unpublished randomised and quasi-randomised trials evaluating the effects of one or more described antenatal fetal surveillance regimens were searched, the optimal frequency of umbilical artery Doppler surveillance is unclear.

Our randomized controlled study was conducted on patients with high risk pregnancies at their third trimester who attended Ain Shams University Maternity Hospital. A total of 292 high risk pregnant women fulfilling the inclusion criteria were selected by random sampling and divided between two groups with 146 patients in each group. Group I underwent Doppler every other week and Group II underwent Doppler once weekly.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-06-29
• Study First Submitted QC: 2018-06-29
• Study First Posted: 2018-07-12
• Primary Completion: 2019-07-01
• Study Completion: 2019-09-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 292

Inclusion Criteria

• I-Singleton pregnancy. II-In the third trimester (starting from 28 weeks of gestation till the time of delivery), Gestational age will be determined by the date of the last menstrual period and early ultrasound.

III-Patient considered as high-risk pregnancies will be included in this study.

The following will be considered as high-risk status:

1. Previous obstetric history of preeclampsia or eclampsia, abruptio placenta, intra-uterine growth restriction or still birth.

2. Pre-existing medical disorders like:

   1. Pregestational diabetes (Ang et al., 2006)
   2. Renal diseases (such as nephrotic syndrome, chronic renal failure, renal transplant and hemodialysis) (Divon and Ferber, 2012).
   3. Autoimmune diseases (such as systemic lupus erythromatosis and rheumatoid arthritis) (Divon and Ferber, 2012).
   4. Acquired thrombophilias (such as antiphospholipid syndrome). On the other hand, inherited thrombophilias (such as protein C or S deficiency) are not associated with IUGR (Reeves and Galan, 2012).
   5. Chronic maternal hypoxemia due to pulmonary disease (such as uncontrolled asthma, chronic obstructive pulmonary disease and cystic fibrosis), cardiac disease (such as cyanotic heart disease) or hematologic disorders (such as severe anemia, sickle cell anemia and β-thalassemia) (Baschat et al., 2012).

3. Current preeclampsia or pregnancy-induced hypertension (PIH). PIH is diagnosed in women whose blood pressure reaches 140/90 mm Hg or greater for the first time after midpregnancy, but proteinuria is not identified. Preeclampsia is best described as pregnancy-specific syndrome that can affect virtually every organ system.It is much more than simply gestational hypertension with proteinuria (Cunningham et al, 2010).

IV- Obtaining valid informed consent to participate in the study

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Exclusion Criteria

• I-Patients with congenital anomaly of the fetus. As this will affect fetal outcome with no effect of Doppler changes.

II- Patients with multiple gestations. As they have different growth pattern. III- Patients with unconfirmed Gestational age due to lack of sure reliable date and absent early trimesteric scan. As we cannot diagnose small for gestational age without sure date.

IV- Withdrawal of consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weekly Umbilical Artery Doppler	Umbilical artery Doppler	will undergo Doppler every week
Bi-Weekly Umbilical Artery Doppler	Umbilical artery Doppler	will undergo Doppler every other week

Primary Outcome Measures

Name	Time	Method
Neonatal admission to r intensive care unit within the first 24 hours	first 24 hours of life	Neonatal admission to special care and/or intensive care unit within the first 24 hours

Secondary Outcome Measures

Name	Time	Method
Stillbirth	at delivery	Stillbirth
Induction of labour	24 hours	Induction of labour
Neonatal death	28 days	Neonatal death
Fetal acidosis	at delivery	cord blood pH
Apgar score less than seven at five minutes	5 minutes	Apgar score less than seven at five minutes
Preterm labour	37 weeks	onset of labour before 37 completed week of pregnancy
Gestational age at birth	28 weeks	Gestational age at birth
Infant respiratory distress syndrome	24 hours	Infant respiratory distress syndrome
Hypoxic ischaemic encephalopathy	96 hours	Hypoxic ischaemic encephalopathy
Intraventricular haemorrage	96 hours	Intraventricular haemorrage
Necrotizing enterocolitis	96 hours	Necrotizing enterocolitis

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt