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

NCT03584763 | Completed

• 1 other identifier: HRD2010
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

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.

Conditions

High Risk Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Stillbirth

  at delivery

• Neonatal death

  28 days

• Fetal acidosis

  at delivery

• Apgar score less than seven at five minutes

  5 minutes

• Induction of labour

  24 hours

Study Arms (2)

Bi-Weekly Umbilical Artery Doppler

ACTIVE COMPARATOR

will undergo Doppler every other week

Diagnostic Test: Umbilical artery Doppler

Weekly Umbilical Artery Doppler

EXPERIMENTAL

will undergo Doppler every week

Diagnostic Test: Umbilical artery Doppler

Interventions

Umbilical artery Doppler DIAGNOSTIC_TEST

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.

Bi-Weekly Umbilical Artery Doppler; Weekly Umbilical Artery Doppler

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Pregestational diabetes (Ang et al., 2006)
• Renal diseases (such as nephrotic syndrome, chronic renal failure, renal transplant and hemodialysis) (Divon and Ferber, 2012).
• Autoimmune diseases (such as systemic lupus erythromatosis and rheumatoid arthritis) (Divon and Ferber, 2012).
• 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).
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, 11221, Egypt

Location

Related Publications (3)

• 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.

  PMID: 11803092 RESULT

• 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.

  PMID: 24222334 RESULT

• Salama MH, Rizk HH, Nawara M. Frequency of third trimester umbilical artery Doppler for improving neonatal outcomes in high-risk pregnancies: a randomized trial. Obstet Gynecol Sci. 2023 May;66(3):161-168. doi: 10.5468/ogs.22130. Epub 2023 Jan 3.

  PMID: 36593702 DERIVED

Study Officials

• Ashraf F Nabhan, Professor

  Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding of the patients or staff in this study is not generally feasible. However, the measured outcomes in this study are objective and are unlikely to be biased by lack of blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynaecology

Model Details: 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

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 12, 2018
• Study Start: January 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)