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

High Risk Pregnancy Clinical Trial

Official title:

Frequency of Performing Umbilical Artery Doppler in the Third Trimester in High Risk Pregnancy A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03562598
• Other study ID #: HRD2010
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: June 2018
• Source: Ain Shams Maternity Hospital
• Contact: Ashraf F Nabhan, Professor
• Phone: 00201223317347
• Email: ashraf.nabhan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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According to a Cochrane Pregnancy and Childbirth Group's systematic review and meta-analysis, in which Published and unpublished randomised and quasi-randomised trials evaluating the effects of one or more described antenatal fetal surveillance regimens were searched, the optimal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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 292
• Est. completion date: August 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 ß-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

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.

Related Conditions & MeSH terms

• High Risk Pregnancy

Intervention

Diagnostic Test:
• Umbilical 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. Review. — View Citation

Alfirevic Z, Stampalija T, Gyte GM. Fetal and umbilical Doppler ultrasound in high-risk pregnancies. Cochrane Database Syst Rev. 2013 Nov 12;(11):CD007529. doi: 10.1002/14651858.CD007529.pub3. Review. Update in: Cochrane Database Syst Rev. 2017 Jun 13;6:C — View Citation

Outcome

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