CompletedNCT03584763Updated Apr 1, 2022

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

An interventional study of Umbilical artery Doppler in High Risk Pregnancy, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-04-01.

Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention

From the registry’s dates

Registered 5 months after the study started (first participant enrolled Jan 2018, registered Jun 2018).

Phase: Not applicable
Study type: Interventional
Enrollment: 292
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: Female

Study 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.

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According to a Cochrane Pregnancy and Childbirth Group's systematic review and meta-analysis, in which Published and unpublished randomised and quasi-randomised trials evaluating the effects of one or more described antenatal fetal surveillance regimens were searched, the optimal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

Conditions studied

High Risk Pregnancy

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: Female
Accepts healthy volunteers: No

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:

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

Exclusion criteria

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.

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 292 participants (actual)

Study arms

Active comparator
Bi-Weekly Umbilical Artery Doppler
will undergo Doppler every other week
Diagnostic Test: Umbilical artery Doppler
Experimental
Weekly Umbilical Artery Doppler
will undergo Doppler every week
Diagnostic Test: Umbilical artery Doppler

Interventions

Diagnostic testUmbilical artery Doppler
Umbilical artery Doppler ultrasound will be performed by most expert sonographer in umbilical artery Doppler at the special care unit, using a 3.5MHz transabdominal probe of SAMSUNG MEDISON, SONOACE R5 ultrasound machine, using the standard protocol of the unit for minimizing the interobserver variations.

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Ain Shams University Maternity Hospital
Cairo, 11221, Egypt

References and documents

Publications

Alfirevic Z, Roberts D, Martlew V. How strong is the association between maternal thrombophilia and adverse pregnancy outcome? A systematic review. Eur J Obstet Gynecol Reprod Biol. 2002 Feb 10;101(1):6-14. doi: 10.1016/s0301-2115(01)00496-1. PubMed 11803092 ↗
Alfirevic Z, Stampalija T, Gyte GM. Fetal and umbilical Doppler ultrasound in high-risk pregnancies. Cochrane Database Syst Rev. 2013 Nov 12;2013(11):CD007529. doi: 10.1002/14651858.CD007529.pub3. PubMed 24222334 ↗

Individual participant data

Plan to share: No — The Investigator will make certain that an appropriate informed consent process is in place to ensure that potential research subjects are fully informed about the nature and objectives of the clinical study, the potential risks and benefits of study participation and their rights as research subjects. The Investigator will obtain the written, signed informed consent of each subject prior to performing any study-specific procedures. The Investigator will retain the original signed informed consent form. Personal information will not be collected or shared. Unique personal data will be her hospital number. Participants files will be maintained in storage for a period of 3 years after completion of the study.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03584763
Lead sponsor: Ain Shams University
Responsible party: Mohamed Hamed Salama (Lecturer of Obstetrics and Gynaecology, Ain Shams University) — Principal investigator
First posted: Jul 12, 2018
Start date: Jan 1, 2018
Primary completion: Jul 1, 2019
Completion: Sep 1, 2019
Last update: Apr 1, 2022

Study contacts

Ashraf F Nabhan, Professor

principal investigator · Faculty of Medicine, Ain Shams University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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